New Challenges in Psycho Oncology Research III A Systematic Review

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Received: 14 March 2017 Revised: 19 March 2017 Accepted: 20 March 2017

DOI: 10.1002/pon.4431

INVITED EDITORIAL

New Challenges in Psycho‐Oncology Research III: A systematic


review of psychological interventions for prostate cancer
survivors and their partners: clinical and research implications
Suzanne K. Chambers1,2,3,4,5,6 | Melissa K. Hyde1,2 | David P. Smith1,6,7,8 |

Suzanne Hughes7 | Susan Yuill7 | Sam Egger7 | Dianne L. O'Connell7,8,9 | Kevin Stein10 |

Mark Frydenberg6,11,12 | Gary Wittert13 | Jeff Dunn1,2,5

1
Menzies Health Institute Queensland, Griffith University, Gold Coast, Queensland, Australia
2
Cancer Research Centre, Cancer Council Queensland, Brisbane, Queensland, Australia
3
Prostate Cancer Foundation of Australia, Sydney, New South Wales, Australia
4
Health & Wellness Institute, Edith Cowan University, Perth, Australia
5
Institute for Resilient Regions, University of Southern Queensland, Toowoomba, Queensland, Australia
6
Australian and New Zealand Urogenital and Prostate Cancer Trials Group, Sydney, New South Wales, Australia
7
Cancer Research Division, Cancer Council NSW, Sydney, New South Wales, Australia
8
Sydney Medical School‐Public Health, University of Sydney, Sydney, New South Wales, Australia
9
School of Medicine and Public Health, University of Newcastle, Newcastle, New South Wales, Australia
10
Behavioral Sciences and Health Education, Rollins School of Public Health, Emory University, Atlanta, Georgia, USA
11
Department of Urology, Monash Health, Melbourne, Victoria, Australia
12
Department of Surgery, Faculty of Medicine, Monash University, Melbourne, Victoria, Australia
13
Freemasons Foundation Centre for Men's Health, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia

Correspondence
Suzanne Chambers, Menzies Health Institute Queensland, Griffith University, Gold Coast Campus, QLD 4222, Australia.
Email: suzanne.chambers@griffith.edu.au
Funding information
National Health and Medical Research Council; NHMRC Centre for Research Excellence in Prostate Cancer Survivorship, Grant/Award Number: APP1116334

1 | B A CKG R O U N D 2012, there were over 1.1 million incident cases of PCa diagnosed
and more than 300 000 deaths worldwide.5 Five‐year prevalence esti-
The medical and social context of prostate cancer (PCa) has changed mates suggest that there are over 3.8 million PCa survivors globally6
dramatically since the introduction of PSA testing for early detection with this expected to increase rapidly in future.7 The challenges we
1
in the late 1980s, leading to a peak in incidence in the developed face in meeting the needs of these men and their families into the
world in the 1990s and again a decade later.2 Since that time, novel future are vast.
PCa treatments have rapidly emerged in the radiation and medical Up to 75% of men treated for localised PCa report severe and
oncology field, as well as surgical advances.3 The recent emergence persistent treatment side‐effects including sexual dysfunction, poor
of active surveillance for low‐risk disease has further expanded possi- urinary or bowel function.8 Psychosocial concerns are prevalent with
4
ble treatment approaches. Market forces from consumers, clinicians, 30%‐50% of PCa survivors reporting unmet sexuality, psychological,
and the therapeutic industry have driven changes in clinical and surgi- and health system and information needs9,10 and 10%‐23% of men
cal management and treatment; however, psycho‐oncological research clinically distressed.11 Risk of suicide is increased after PCa diagno-
and survivorship care arguably has lagged behind. Specifically, sis12,13 and can persist for a decade or more.14 In the longer term,
although men are surviving longer, they may not be surviving well. In 30%‐40% of PCa survivors report persistent health‐related distress,

--------------------------------------------------------------------------------------------------------------------------------
This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided
the original work is properly cited.
© 2017 The Authors. Psycho‐Oncology Published by John Wiley & Sons Ltd.

Psycho‐Oncology. 2017;26:873–913. wileyonlinelibrary.com/journal/pon 873


874 CHAMBERS ET AL.

worry, low mood15 and diminished quality of life (QoL).16 Partners of 2.2 | Selection criteria
PCa survivors also experience ongoing psychological concerns and
Studies were included if the following pre‐specified criteria were met:
changes in their intimate relationships17; with these impacts driven
in part by the man's level of distress, sexual concerns and physical
• Randomised controlled trial design.
QoL.18
In 2011, our group published the first criterion‐based systematic • ≥80% of participants were men diagnosed with PCa (no restric-

review of psychosocial interventions for men with PCa and their part- tions on disease stage or time since diagnosis) and/or partners/

ners. 19
We concluded that group cognitive‐behavioural interventions carers of men with PCa or results for men with PCa and/or part-

and psycho‐education appeared to be helpful in promoting better psy- ners/carers were reported separately.

chological adjustment and QoL for men with localised PCa, and coping • Intervention(s) were psychosocial or psychosexual.
skills training for female partners may improve their QoL. However, • Outcome(s) reported were psychosocial (including psychological,
data were limited by inconsistent results and low study quality. In relationships, decision‐making), health‐related QoL, and sexuality
response to the increasing burden of PCa, uncertainties about optimal outcomes (including sexual function, bother, and use of erectile
psychosocial care, and additions to the literature, we updated and dysfunction aids or treatments). Mediator outcomes such as cogni-
extended this review with the intent of determining benefit and tive reframing and coping were not included.
acceptability, and considering intervention content and format. In
• Outcomes were assessed using validated scales or scales adapted
brief, we considered the range of psychosocial and psychosexual inter-
from these.
ventions that may be optimal, and for whom.
• Intervention(s) were compared with usual care or supportive atten-
tion or no intervention, and/or another intervention(s) with differ-
ent psychosocial or psychosexual components, and/or the same
2 | METHODS intervention components with a different mode(s) of delivery. Mul-
timodal interventions such as lifestyle interventions were only
Two clinical questions guided the review20: In men diagnosed with PCa
included if they had a psychosocial or psychosexual component.
(Q1) and/or in their partners/carers (Q2), what is the effectiveness of
• Published in English language.
different psychosocial or psychosexual interventions compared with
(i) other psychosocial or psychosexual interventions, or (ii) usual care • Published after December 31, 1999 up to January 9, 2017.
or no intervention, in maintaining or improving QoL or psychological
wellbeing? Psychosocial or psychosexual interventions were included Two authors reviewed titles and abstracts and excluded irrelevant
if they had one or more of the following components: education articles and duplicates. Full‐text articles that potentially met criteria
(psycho‐education, psycho‐sexual education, PCa education), were then retrieved and reviewed by one author. A random sample
cognitive‐behavioural (cognitive restructuring, behaviour change, of 5% of articles was assessed for inclusion by 2 authors with 100%
cognitive‐behavioural stress management), relaxation (relaxation tech- agreement achieved.
niques, meditation), supportive counselling (counselling/psychother-
apy, health professional discussion), peer support (peer support, 2.3 | Data extraction
social support including discussion within a group of peers), communi-
One author extracted pre‐specified study characteristics (eg, partici-
cation (skill development to encourage communication with partners,
pant demographics, PCa treatments, intervention content, delivery
health professionals or generally) and decision support (aids or tools
and results) and another checked each extract. To support data extrac-
to assist decisions about PCa treatment or use of sexual aids). The
tion, published descriptions of interventions were content analysed to
review and reporting of results were guided by the PRISMA state-
create a framework of common psychosocial or psychosexual inter-
ment.21 Ethical approval was not required.
vention components (Appendix B).

2.4 | Risk of bias


2.1 | Search strategy The Cochrane Collaboration's tool was used to assess risk of bias
Our prior review (until December 1, 2009) identified 195 articles regarding sequence generation, allocation concealment, blinding of
19
that met criteria for the current study. Searches were updated participants and personnel collecting outcome data, incomplete out-
from 2009 onwards. Eleven relevant databases were searched (eg, come data, selective outcome reporting, and other sources (eg, differ-
MEDLINE, Embase, PsycINFO, and CINAHL; Figure 1) up to January ence in follow‐up between arms).22 Blinding is difficult to achieve in
9, 2017. Free‐text terms and database‐specific subject headings for psychological trials where consent mechanisms require participants
PCa and psychological and QoL outcomes were used (Appendix A to understand differences in treatments, which are often clearly dis-
shows full search strategies). Reference lists of included articles were cernible to the participant (eg, therapist‐delivered intervention vs
also searched. ClinicalTrials.gov (http://clinicaltrials.gov/) (June 2016) self‐help materials).19 On this basis, blinding was excluded from assess-
and the International Clinical Trials Registry Platform (http://apps. ment. Clinical trial registries at https://clinicaltrials.gov/, http://www.
who.int/trialsearch/) (October 2016) were searched for ongoing and isrctn.com/, and http://www.anzctr.org.au/ were searched for proto-
completed trials and associated publications. cols of included studies to identify pre‐specified outcomes and
CHAMBERS ET AL. 875

FIGURE 1 PRISMA flow diagram of study selection for systematic review

determine whether there was a risk of bias from selective outcome reported outcome (at the longest reported follow‐up), there was in
reporting. Differences in evaluations were resolved by discussion and favour of the intervention(s): (i) a statistically significant difference
where necessary adjudication by a third author. between arms; (ii) a moderate or large standardised effect size (eg,
Cohen's d ≥ 0.5, η2 ≥ 0.06); or (iii) a difference in mean score changes
from baseline calculated by ANCOVA or multiple linear regression
2.5 | Intervention acceptability between arms ≥10% of the scale of the differences in means. For a
23
The criteria of Yanez et al were used to identify and evaluate aspects given measurement scale, results from subscales were only considered
of interventions that indicate acceptability: ≥40% recruitment rate, in the absence of an overall score.
≥70% retention at end of intervention or follow‐up (or <30% with-
drawal), and ≥70% average intervention attendance.

3 | RESULTS
2.6 | Analyses
It was anticipated that some trials may be underpowered.19 Thus, an
3.1 | Search results
intervention was considered potentially beneficial compared with In all, 6631 citations were identified of which 161 full‐text (includ-
usual care or better than another intervention if for at least one ing 16 identified from reference lists) were retrieved and evaluated
876 CHAMBERS ET AL.

as well as 195 articles from the prior review.19 Of the total 356 29%; retention: 74% vs 64%). Approximately 40% of person and cou-
full‐text articles assessed for inclusion, 68 articles met criteria and ple interventions indicated acceptable mean attendance (Table 1).
reported a total of 57 RCTs. Forty‐one RCTs reported in 51 articles
(2 publications for 10 studies) included only patients (Q1); 1 RCT
included only partners (Q2); 15 RCTs reported in 16 articles (2 pub- 3.5 | Intervention effects
lications for 1 study) included patients and partners (Q1 and Q2)
Three trials reported couple‐focused interventions that, compared
(Figure 1). Most studies were excluded because of study design
with usual care, increased partner distress about sexual function,24
or population not meeting criteria, or results for patients or part-
worsened partner challenge appraisal,25 and reduced relationship satis-
ners/carers were not reported. Clinical trial registry searches identi-
faction and intimacy for partners who had high levels of these con-
fied 47 trials: 25 completed (16 included in the review); 20
structs at baseline26 (Appendix D). By contrast, for patients, all
ongoing; 2 terminated (slow accrual, funding unavailable).
intervention effects indicated improvement. Four trials included out-
comes of interest27-30 but did not report comparative results and were
3.2 | Risk of bias excluded. The remaining 29 trials (21 person‐focused: 20 patients, 1
Risk of bias from sequence generation (61% Q1; 64% Q2) and alloca- partner and patient; 8 couple‐focused) showed a benefit for psychoso-
tion concealment (71% Q1; 79% Q2), was unclear, and high for incom- cial or psychosexual outcomes (Table 2). Most (80%) person‐focused
plete outcome data (43% Q1; 43% Q2) for most studies. Risk of bias interventions were for men with localised disease. Of the effective
from selective outcome reporting was also high for majority of partner interventions, most (95% person‐focused, 86% couple‐focused) signif-
studies (43%) and unclear for patient studies (63%). Most studies were icantly impacted patient outcomes. No person‐focused trials had a
low risk for other sources of bias (70% Q1; 86% Q2) (Appendix C). significant effect on relationship outcomes. No couple‐focused trials
improved decision‐making outcomes or fatigue. No trials had a signifi-
cant effect on partner QoL or sexuality outcomes regardless of inter-
3.3 | Trial characteristics
vention focus. Table 3 reports intervention components.
Included trials randomised 8378 men (range 27‐740; 48% of trials had
<100 participants), and 1313 partners (range 27‐263; 57% of trials had
<100 participants; >90% partners were female in 14 trials; >80% part- 3.5.1 | Person‐focused
ners were spouses in 12 trials). Most (67%) trials were conducted in
Decision making
North America. In 10 trials (4 including partners), participation was
Six trials improved patient decision‐making mostly for men diagnosed
determined by socio‐demographic background (eg, African‐American),
with early stage disease and/or recruited prior to treatment. Decision
emotional state (eg, distress), or QoL (eg, urinary or sexual dysfunction,
support, aid, or navigation reduced patient uncertainty,31,32 conflict,33
ADT treatment side‐effects, fatigue). When reported, mean or median
and regret34,35 about their treatment decision, and a combined online
age was below 65 years in 49% of trials for patients and below 65 years
psycho‐educational intervention and moderated peer forum also
in 100% of trials for partners. In approximately half of trials (57% of
reduced regret.36,37 Patient self‐efficacy or confidence in their deci-
patient trials, 40% of partner trials) reporting college/university educa-
sion‐making was increased by decision navigation34 and interactive
tion, >50% of participants were university/college educated. In 25 tri-
education interventions.38
als (45%), men were diagnosed with or treated for localised disease in
the previous 6 months (14 trials enrolled men prior to treatment or
treatment decision). Men with recurrent or metastatic disease and TABLE 1 Acceptability of included trials comprising person‐ (n = 43)
their partners were included in 16% and 21% of trials, respectively. and couple‐ (n = 14) focused interventions
The number of relevant outcomes measured by trials varied from 1 Acceptability category Person* N (%) Couple N (%)
to 16 (patient) and 2 to 12 (partner). Most common outcomes for 1. Recruitment
patients were sexual bother and/or function and mental health; and for No: <40% 8 (19%) 6 (43%)
partners were relationships, general and cancer‐specific distress. Trials Yes: ≥40% 31 (72%) 4 (29%)
reported 41 patient, 1 patient and partner, and 1 partner person‐focused Unclear: Not reported 4 (9%) 4 (29%)
(targeted and delivered to the individual or person) interventions and 14 2. Retention/Withdrawal
couple‐focused interventions (targeted and delivered to the couple as a No: Retention <70%; 2 (5%) 1 (7%)
dyad) (Appendix D). Most interventions were compared with usual or Withdrawal > 30%
standard care; however, what the comparison group entailed was rarely Yes: Retention ≥70%; 32 (74%) 9 (64%)
Withdrawal ≤ 30%
described. Follow‐up ranged from immediately post‐intervention to
Unclear: Not reported 9 (21%) 4 (29%)
approximately 19 months (person‐focused, Median = 3 months) or
3. Attendance
12 months (couple‐focused, Median = 6 months) post‐intervention.
No: <70% 7 (16%) 2 (14%)
Yes: ≥70% 18 (42%) 6 (43%)
3.4 | Intervention acceptability Unclear: Not reported 18 (42%) 6 (43%)
Trials comprising interventions that were person‐focused were more *Includes 2 person‐focused trials for partners both rated acceptable on
acceptable than couple‐focused interventions (recruitment: 72% vs recruitment, retention, and attendance.
TABLE 2 Person ‐ (N = 21) and couple ‐ (N = 8) focused trials that significantly (or moderate‐large effect size) and positively impacted psychosocial or psychosexual outcomes
CHAMBERS

Outcomes Sig level or


Study N Intervention(s) that had an effect Comparison Components Deliverer Follow‐up impacted effect size *
ET AL.

Person‐focused interventions
Badger 71 1. Interpersonal psychotherapy + 2. Health education 1. E, SC, PS, C 1. Nurse or social 8 weeks post‐ Depression
2011,2013 cancer education: patient and attention: patient worker intervention • Patient P < 0.001
partner and partner 2. E • Partner P < 0.05
Patients + 2. Research
partners 8 (patients) or 4 (partners) individual telephone sessions over assistants Negative affect
8 weeks • Patient P < 0.001

Stress
• Patient P < 0.001

Fatigue
• Patient P < 0.01
• Partner P < 0.01

Social well‐being
• Partner P < 0.01

Spiritual well‐being
• Patient P < 0.01
• Partner P < 0.01
Bailey 39 Uncertainty management: cognitive UC E, CB, C, DS Nurse ~5 weeks post‐ QoL P = 0.01
2004 reframing tailored to patient needs intervention

5 weekly individual telephone


sessions
Berry 494 Decision support UC E, C, DS Self‐admin 6 months post‐ Decisional P = 0.04
2012,2013 intervention uncertainty
1 individual internet session
Campo 40 Qigong Stretch control R Qigong master 1 week post‐ Fatigue P = 0.02
2014 and instructors intervention
24 twice weekly group Distress P = 0.002
face‐to‐face sessions
Carmack‐Taylor 134 1. 30 minutes expert speaker or UC 1. E, PS Facilitator 6 months post‐ Anxiety Sub‐group
2006,2007 facilitated discussion supervised intervention P = 0.02
2. E, PS by clinical
2. 90 minutes expert speaker or psychologist Depression Sub‐group
facilitated discussion P = 0.002

Both interventions 21 group


face‐to‐face sessions over
6 months

(Continues)
877
878

TABLE 2 (Continued)

Outcomes Sig level or


Study N Intervention(s) that had an effect Comparison Components Deliverer Follow‐up impacted effect size *

Chabrera 142 Decision aid UC E, C, DS Self‐admin 3 months Decisional conflict P < 0.001
2015 post‐baseline
Individual printed
Chambers 740 Telephone psycho‐educational UC E, CB, R, DS Nurse Counsellor 24 months post‐tx Cancer‐specific Sub‐group
2013 distress P < 0.008
5 individual sessions: 2 pre‐tx, and
3 weeks, 7 weeks and 5 months Mental health Sub‐group
post‐tx P = 0.04
Diefenbach 91 1. Prostate Interactive Educational 2. Control 1. E, DS Self‐admin Immediately post‐ Confident about tx P = 0.02
2012 System with or without tailoring Read Standard intervention choice
to patient's information seeking National Cancer 2. E
style (combined results from arms) Institute booklets Prefer more P = 0.02
on PCa for information
1 individual internet/CD‐ROM 45 minutes
session
1 individual booklet
Hacking 123 Decision navigation UC DS Research 6 months post‐ Decisional self‐ P = 0.009
2013 assistants consult efficacy
1 individual face‐to–face or
telephone session, audiotape Decisional regret P = 0.04
and written notes
Lepore 250 1. Education + group discussion Standard medical 1. E, PS Multiple health 12 months post‐ Mental health Sub‐group
2003; (with family member/friend) care professionals intervention P < 0.05
Helgeson 2. E
2006 2. Education Depression Sub‐group
P < 0.05
Both 6 weekly face‐
to‐face group sessions Sexual bother P < 0.01
Mishel 252 1. Decision navigation: Patient only Control 1. E, SC, C, DS Nurse, Self‐admin 3 months post‐ Decisional regret P = 0.01
2009 baseline
2. Decision navigation: Patient and 2. E, SC, C, DS
support person

Both information + telephone


calls to review content, identify/
formulate questions and practise
skills delivered to patient and/or
support person individually (not
dyad)

Both individual/couple booklet,


DVD and 4 telephone calls over
7‐10 days

(Continues)
CHAMBERS
ET AL.
TABLE 2 (Continued)

Outcomes Sig level or


Study N Intervention(s) that had an effect Comparison Components Deliverer Follow‐up impacted effect size *
CHAMBERS

Penedo 191 1. 10‐week group CB stress 2. Half‐day stress 1. E, CB, R, SC, PS, C Therapist 12‐13 weeks post‐ Cancer‐related QoL P < 0.05
ET AL.

2006; management techniques + management baseline


Molton relaxation training seminar (same 2. E Sexual function Sub‐group
2008 content) P < 0.05
10 weekly group face‐to‐face
sessions 1 group face‐to‐face
session
Penedo 93 1. 10‐week group CB stress 2. Half‐day stress 1. E, CB, R, SC, PS, C Therapist 12‐13 weeks post‐ Cancer‐related QoL P = 0.006
2007 management techniques + management baseline
relaxation training seminar (same 2. E
content)
10 weekly group face‐to‐face
sessions 1 group face‐to‐face
session
Petersson 118 Group rehabilitation programme No group E, CB, R Multiple health 3 months post‐ Cancer‐related Sub‐group
2002 (only or + individual support) intervention professionals intervention start distress P < 0.01
including psychosocial (Avoidance)
components + physical activity

8 group face‐to‐face sessions over


8 weeks + booster group session
after 2 months + written
information
Schofield 331 Nurse‐led group psycho‐educational UC E, PS, C Uro‐oncology 6 months post‐tx Depression P = 0.0009
2016 consultation nurse

4 x group face‐to‐face sessions


(beginning, mid, completion, and
6 weeks post‐radiotherapy) +
1 individual session after 1st
group consultation
Siddons 60 CB group intervention Wait‐list E, CB, R, C Psychologist 8 weeks Masculine self‐ P = 0.037
2013 (end of intervention) esteem
8 group face‐to‐face sessions
over 8 weeks Sexual confidence P = 0.001

Sexual QoL P = 0.046

Orgasm satisfaction P = 0.047


Traeger 257 1. 10‐week group CB stress 2. Half‐day stress 1. E, CB, R, SC, PS, C Therapist 12‐13 weeks post‐ Emotional well‐being P < 0.05
2013 management techniques + management baseline
relaxation training seminar (same 2. E
content)
10 weekly group face‐to‐face
sessions 1 group face‐to‐face
session

(Continues)
879
880

TABLE 2 (Continued)

Outcomes Sig level or


Study N Intervention(s) that had an effect Comparison Components Deliverer Follow‐up impacted effect size *

Weber 30 Peer support UC PS Peer (>3 years 8 weeks post‐ Sexual bother P = 0.014
2004 PCa survivor) baseline
8 individual face‐to‐face sessions
over 8 weeks
Weber 72 Peer support UC PS Peer (>3 years 8 weeks post‐ Depression P = 0.03
2007 a,b PCa survivor) baseline
8 individual face‐to‐face sessions Self‐efficacy P = 0.005
over 8 weeks
Wootten 142 1. Online psycho‐education + 2. Moderated peer 1. E, CB, PS, C Self‐admin 6 months post‐ Distress P = 0.02
2015, 2016 moderated peer online forum online forum (F) baseline
(PsychE + F) 2. PS Decisional regret P = 0.046
Individually accessed
6 individual sessions over over 10 weeks Sexual satisfaction Sig level NR,
10 weeks Difference
1.24 (95%CI
0.25‐2.22)
Yanez 74 1. CB stress management + 2. Health promotion 1. E, CB, R, PS, C Therapist 6 months post‐ Depression Cohen's d 0.5
2015 relaxation/stress reduction attention‐control baseline
techniques 2. E
10 weekly group
10 weekly group online sessions online sessions
Couple‐focused interventions
Campbell 30 Partner assisted coping skills training UC E, CB, R, C Therapist ~6 weeks post‐ Cohen's d
2007 baseline Sexual bother
6 ~weekly dyadic telephone sessions •Patient 0.5

Depression
• Partner 0.5
Chambers 189 1. Peer‐delivered telephone support UC 1. E, CB, PS, C PCa Nurse 12 months post‐ Use of ED tx
2015 counsellor recruitment Patient p < 0.01
2. Nurse‐delivered telephone 2. E, CB, SC, C, DS
counselling

8 (recruited pre‐surgery) or 6
(recruited post‐surgery) dyadic
telephone sessions: 2 pre‐surgery
and/or 6 post‐surgery over 22
weeks
Couper 62 Cognitive‐existential couple therapy UC CB, SC Mental health 9 months post‐ Relationship function
2015 professional baseline Partner P = 0.009
6 weekly dyadic face‐to‐face
sessions

(Continues)
CHAMBERS
ET AL.
TABLE 2 (Continued)
CHAMBERS

Outcomes Sig level or


Study N Intervention(s) that had an effect Comparison Components Deliverer Follow‐up impacted effect size *
ET AL.

Giesler 99 Post‐tx nursing support UC E, C Oncology nurse 12 months post‐tx Sexual limitation P = 0.02
2005
6 monthly dyadic sessions; 2 face‐to‐ Cancer worry P = 0.03
Patient data face and 4 telephone sessions
only
Manne 71 Intimacy‐Enhancing Therapy UC E, CB, SC, C Therapist 8 weeks post‐ Cancer concern
2011 baseline • Patient Sub‐group
5 dyadic face‐to‐face sessions over P = 0.02
8 weeks Cancer‐related
distress
• Partner Sub‐group
P = 0.02
Relationship
satisfaction
• Partner Sub‐group
P = 0.0002
Intimacy
• Partner Sub‐group
P = 0.001
Thornton 80 patients, Pre‐surgical communication UC delivered by a SC, C Trained counsellor 1 year post‐surgery Stress
2004 65 partners enhancement nurse Partner partial
η2 = 0.12
1 dyadic face‐to‐face session
Titta 57 Intracavernous injection‐focused Control (partner E, SC, C NR 18 months post‐ Erectile function P < 0.05
2006 sexual counselling for couples invited to surgery
following patient training in follow‐up visits Sexual satisfaction P < 0.05
Patient data PGE1‐intracavernous injections every 3 months)
only Sexual desire P < 0.05
Six 3‐monthly dyadic face‐to‐face
sessions
Walker 27 Educational intervention for UC E Researcher 6 months post‐ Cohen's d
2013 couples to maintain intimacy familiar with enrolment Intimacy
ADT •Patient 0.6
1 dyadic face‐to‐face session +
booklet Dyadic adjustment
• Patient 1.0
• Partner 0.5

*Precision of effect and size of effect correspond to longest reported follow‐up; size of effect only reported if not significant. C, Communication; CB, Cognitive‐behavioural; DS, Decision Support; E, Education; ED, Erec-
tile dysfunction; NS, Not significant; PCa, Prostate cancer; PS, Peer Support; QoL, Quality of Life; R, Relaxation; SC, Supportive Care; Tx, treatment; UC, Usual or standard care
881
882 CHAMBERS ET AL.

TABLE 3 Inclusion of specific components in effective in N = 34 person‐focused interventions and N = 9 couple‐focused interventions
Person‐focused Couple‐focused
interventions* interventions*
Components % (n) % (n)

Education 85% (29) 78% (7)


(psycho‐education, psycho‐sexual education, PCa education)
Communication 44% (15) 78% (7)
(partner, sexual, health professional, general or type not specified)
Peer support 41% (14) 11% (1)
(peer discussion, social support^)
Cognitive‐behavioural 29% (10) 56% (5)
(cognitive restructuring, behaviour change, cognitive‐behavioural stress management)
Decision support 24% (8) 11% (1)
(PCa treatment, sexual aids)
Relaxation 24% (8) 11% (1)
(meditation, relaxation techniques)
Supportive counselling 12% (4) 56% (5)
(counselling/psychotherapy, health professional discussion)

*Note that some trials had multiple arms and more than one effective intervention.
^
Social support may include general group discussion with peers.
NB. Total percentages may exceed 100% because of multiple intervention components.
PCa, prostate cancer.

Quality of life moderated peer forum had less distress.36,37 Qigong also decreased
distress43; and a nurse‐led psycho‐education intervention50 and peer
An uncertainty management intervention improved QoL for patients
support51,52 reduced depression. In 2 trials, a 10‐week cognitive‐
on watchful waiting.39 In 2 trials, a 10‐week cognitive‐behavioural
behavioural stress management intervention improved emotional
stress management intervention improved cancer‐specific QoL for
well‐being53 and depression.23
patients with early stage disease.40-42
Mental health and cancer‐specific distress improved in younger,
more highly educated patients who received a tele‐based psycho‐
Fatigue
educational intervention.54 A multi‐modal intervention including cog-
Participants who received Qigong43 or a health education interven-
nitive‐behavioural therapy also reduced cancer‐related distress
tion44,45 experienced reduced fatigue.
(avoidance) in patients with a monitor (cognitive scanning) coping
style.55 Patients with high‐baseline depression or anxiety showed
Sexuality
improvement in these constructs if they were allocated to either a
Five trials reported better sexuality outcomes (80% of trials included multi‐modal intervention including either 30 or 90 minutes of an
majority of men who had radical prostatectomy). Combined education expert speaker/facilitated discussion.56,57 In another trial, patients
and group discussion,46,47 and peer support,48 decreased sexual with lower baseline depression were less depressed if they received
bother. A 10‐week group cognitive‐behavioural stress management a combined education and group discussion intervention.46,47 In this
intervention improved sexual function for men treated with prostatec- same study, patients with lower self‐esteem at baseline had less
tomy (88% erectile dysfunction (ED)) who had high interpersonal sen- depression and better mental health if they participated in either a
sitivity.40,41 Sexual satisfaction improved for patients in a combined combined education and group discussion or education only
online psycho‐educational intervention and moderated peer support intervention.
forum.36,7 Only one trial improved multiple sexual outcomes; in addi- One trial improved patient and partner mental health out-
tion to increased sexual QoL and orgasm satisfaction, Siddons et al49 comes.44,45 Patients in the health education attention intervention
reported increased masculine self‐esteem and sexual confidence for had less depression, negative affect, stress, and greater spiritual well‐
men treated with radical prostatectomy (90% ED) and who received being. Effects on stress were more pronounced for men who were less
a cognitive‐behavioural group intervention. Overall, 60% of trials educated, and greater reductions in depression were experienced if
reported follow‐up immediately following or close to intervention men were older, had lower PCa‐specific QoL, active chemotherapy,
delivery. less social support or cancer knowledge. Patients receiving combined
psychotherapy and education had more positive affect if they were
Mental health more highly educated, had higher PCa‐specific QoL, or more social
Eleven trials improved patient mental health outcomes. Patients support. Partners in the health education intervention had improved
receiving a combined online psycho‐educational intervention and depression, social, and spiritual well‐being.44,45
CHAMBERS ET AL. 883

3.5.2 | Couple‐focused components were often used in a multi‐modal approach, and delivered
through both face‐to‐face and remote technologies, with therapist,
Quality of life
nurse or peer support. In sum, multi‐modal psychosocial and psycho-
Intimacy‐enhancing therapy increased cancer‐specific QoL for patients sexual care for men with PCa, particularly localised disease, is both
with early stage disease and higher symptom‐related concerns at acceptable and effective.
baseline.26 The evidence is less clear for the female partners of these men and
couples as a dyadic unit. Couple‐focused interventions were the least
Sexuality acceptable approach and almost half of the couple interventions pro-
Four trials improved sexuality outcomes for patients only. Coping skills duced poorer outcomes for partners. When couple interventions were
training reduced sexual bother,58 and intracavernous injection‐focused effective, they improved relationship outcomes for the partner but not
sexual counselling increased patient sexual function, sexual satisfac- the man; had a positive effect on the partner's mental health but con-
tion, and desire.59 Post‐treatment nursing support lessened the extent versely; improved sexuality outcomes for the man but not the partner.
to which sexual dysfunction interfered with spousal role activities.60 No interventions improved sexuality outcomes for female partners.
Prostate cancer nurse‐delivered and peer‐delivered telephone Based on these results, effective and acceptable interventions for
counselling interventions uniquely reported increased use of ED treat- female partners and couples remain an area of uncertainty. It may be
ment at 12‐month post‐recruitment follow‐up for men with localised that couples interventions have been primarily focused on the PCa sur-
disease who had prostatectomy.61 vivor's needs, leaving the partner's concerns poorly managed. This is an
area where significant further work is required to understand the
Mental health needs and preferences of couples, and to determine approaches to
Mental health was improved in 5 trials, predominantly for partners. improve sexual and relationship satisfaction for both partners.
58
Coping skills training reduced partner's depressed mood. Pre‐surgical Limitations of the research to date include small sample sizes; low
communication enhancement intervention reduced partner stress.62 statistical power; suboptimal statistical methods in some studies;
Cancer‐related distress lessened in younger women receiving cogni- inconsistency in measurement approaches; a lack of diversity in partic-
tive‐existential couple therapy,63 and partners with high levels of base- ipants—particularly with regards to gay and bisexual men; men with
26
line distress receiving intimacy enhancing therapy. Cancer‐related advanced PCa; and men from socio‐economically deprived; and non‐
worry also reduced for patients receiving post‐treatment nursing Anglo‐Saxon backgrounds. Long‐term survivorship outcomes (>2 years)
support.60 are yet to be addressed. In addition, intervention components were
often described in a vague way such that it was not always clear what
Relationships was actually delivered; and treatment fidelity and therapist adherence
Three trials improved relationship outcomes, mostly for partners. Cog- was in most studies not well described. Strengths of the current review
nitive‐existential couple therapy enhanced relationship function for by comparison with previous reviews include a departure from a
female spouses. 63
Intimacy enhancing therapy was associated with narrow focus on specific intervention type(s), single outcomes, or
improved partner relationship satisfaction and intimacy for partners sub‐groups; a consideration of acceptability as well as statistical signif-
with lower baseline scores on these variables.26 Education to maintain icance; and examination of not only intervention effectiveness but also
intimacy also improved intimacy for patients starting ADT, and dyadic who benefits by considering the influences of socio‐demographic and
adjustment for patients and their female partners. 64 medical characteristics of men and their partners; intervention format
and delivery; and acceptability.

3.6 | Intervention delivery


4.1 | Clinical implications
Effective person‐focused interventions were most commonly delivered
in an individual (53%) or group (47%) setting; face‐to‐face (50%), via Standards for psychosocial care with regards to screening for distress

telephone (26%) or online (26%); by a psychologist/counsellor (41%), are now widely accepted,65 and the validity of the distress thermome-

nurse (29%) or self‐administered (26%). Couple‐focused interventions ter for men with PCa is well established with clear cut‐offs for

were delivered to dyads most commonly face‐to‐face (67%) or by caseness.11 In this review, approximately one‐quarter of interventions

telephone (44%); by a psychologist/counsellor (44%) or nurse (22%). reported effects moderated by socio‐demographic or psychosocial var-
iables; with age, educational level, domain‐specific QOL, baseline men-
tal health, and social support important considerations in designing
4 | DISCUSSION care. Hence, as well as taking into account levels of distress, it is also
important to consider factors that both moderate intervention effec-
Psychosocial and psychosexual intervention can improve decision‐ tiveness and place men at risk of greater psychosocial distress and
related distress, mental health, domain‐specific, and health‐related poorer QOL (such as age, domain‐specific QOL, socio‐economic depri-
QOL in men with PCa. Combinations of educational, cognitive behav- vation) over the longer term.16 Survivorship care plans for PCa will
ioural, communication, and peer support have been most commonly need to be stepped according to the type and depth of need.66,67 In
applied and found effective; followed by decision support and relaxa- conclusion, there is sufficient evidence to recommend multi‐modal
tion; and to a much lesser extent supportive counselling. These psychosocial and psychosexual interventions for men with PCa; with
884 CHAMBERS ET AL.

distress screening and risk and need assessment built in to tailor sup- 10. Smith DP, Supramaniam R, King MT, Ward J, Berry M, Armstrong BK.
port to the individual. As yet, there is insufficient evidence to confirm Age, health, and education determine supportive care needs of men
younger than 70 years with prostate cancer. J Clin Oncol.
the optimal approach for female partners and couples. 2007;25(18):2560‐2566. https://doi.org/10.1200/JCO.2006.09.8046
We note that in this review education and communication support
11. Chambers SK, Zajdlewicz L, Youlden DR, Holland JC, Dunn J. The validity
was commonly applied effectively across both person and couples‐ of the distress thermometer in prostate cancer populations.
focused interventions. By contrast, supportive counselling was often Psychooncology. 2014;23(2):195‐203. https://doi.org/10.1002/pon.3391
used for couples, whereas for patients peer support was more com- 12. Carlsson S, Sandin F, Fall K, et al. Risk of suicide in men with low‐risk
prostate cancer. Eur J Cancer. 2013;49(7):1588‐1599. https://doi.org/
mon. This may reflect in part what support methods are acceptable
10.1016/j.ejca.2012.12.018
to men. Care approaches also need to consider the impact of PCa on
13. Fall K, Fang F, Mucci LA, et al. Immediate risk for cardiovascular events
men's masculine identities and embed sensitivity to these masculinities and suicide following a prostate cancer diagnosis: prospective cohort
in psychosocial and psychosexual interventions in a way that extends study. PLoS Med. 2009;6(12):e1000197. https://doi.org/10.1371/jour-
beyond a reductionist focus on erectile dysfunction.65 nal.pmed.1000197
14. Misono S, Weiss NS, Fann JR, Redman M, Yueh B. Incidence of suicide
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4.2 | Future research
15. Bill‐Axelson A, Holmberg L, Filén F, et al. Radical prostatectomy versus
There is a need for improvement in the field in study quality, especially watchful waiting in localized prostate cancer: the Scandinavian pros-
tate cancer group‐4 randomized trial. J Natl Cancer Inst.
with regard to treatment fidelity. Where interventions are multimodal
2008;100(16):1144‐1154. https://doi.org/10.1093/jnci/djn255
better clarity about therapy components would assist application by
16. Chambers SK, Ng SK, Baade P, et al. Trajectories of quality of life, life
clinicians. There remain gaps in knowledge about effective interventions satisfaction, and psychological adjustment after prostate cancer.
for men with advanced cancer and how to best help couples and partners Psychooncology. 2017. https://doi.org/10.1002/pon.4342
warrants further investigation. Finally, expanded research is needed 17. Wootten A, Abbott J, Farrell A, Austin D, Klein B. Psychosocial inter-
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ACKNOWLEDGEMEN TS prostate cancer. Support Care Cancer. 2013;21(11):2967‐2976. https://
doi.org/10.1007/s00520‐013‐1868‐6
This study is supported by a National Health and Medical Research
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62. Thornton AA, Perez MA, Meyerowitz BE. Patient and partner quality of (Continued)
life and psychosocial adjustment following radical prostatectomy. J Clin
Psychol Med Settings. 2004;11(1):15‐30. # Searches

63. Couper J, Collins A, Bloch S, et al. Cognitive existential couple therapy 18 exp Psychosomatic Medicine/
(CECT) in men and partners facing localised prostate cancer: a 19 exp Stress, Psychological/
randomised controlled trial. BJU Int. 2015;115(S5):35‐45. https://doi.
org/10.1111/bju.12991 20 psycholog*.mp.
21 psychosoci*.mp.
64. Walker LM, Hampton AJ, Wassersug RJ, Thomas BC, Robinson JW.
Androgen deprivation therapy and maintenance of intimacy: a random- 22 (psycho adj soci*).mp.
ized controlled pilot study of an educational intervention for patients 23 (intrusive adj (thinking or thoughts)).mp.
and their partners. Contemp Clin Trials. 2013;34(2):227‐231. https://
24 intrusiveness.mp.
doi.org/10.1016/j.cct.2012.11.007
25 exp Mental Fatigue/
65. Holland J, Watson M, Dunn J. The IPOS new international standard of
quality cancer care: integrating the psychosocial domain into routine care. 26 exp “Conflict (Psychology)”/
Psychooncology. 2011;20(7):677‐680. https://doi.org/10.1002/pon.1978 27 exp Emotions/
66. Schofield P, Chambers SK. Effective, clinically feasible and sustainable: 28 emotion*.mp.
key design features of psycho‐educational and supportive care 29 unhapp*.mp.
interventions to promote individualised self‐management in cancer
care. Acta Oncol. 2015;54(5):805‐812. https://doi.org/10.3109/ 30 happiness*.mp.
0284186X.2015.1010016 31 sad.mp.
67. Hutchison SD, Steginga SK, Dunn J. The tiered model of psychosocial 32 sadness.mp.
intervention in cancer: a community based approach. Psychooncology. 33 (anhedon* or melanchol* or fear* or worr*).mp.
2006;15(6):541‐546. https://doi.org/10.1002/pon.973
34 (stress* or distress* or nervous* or nervos*).mp.
35 (uncertainty or hope or wellbeing).mp.
How to cite this article: Chambers SK, Hyde MK, Smith DP, 36 well being*.mp.
et al. New Challenges in Psycho‐Oncology Research III: A sys- 37 exp Adaptation, Psychological/
tematic review of psychological interventions for prostate can- 38 exp Adjustment/
cer survivors and their partners: clinical and research 39 (cognitive adj3 adjustment).mp.
implications. Psycho‐Oncology. 2017;26:873–913. https://doi. 40 exp Decision Making/
org/10.1002/pon.4431 41 decision making.mp.
42 decisional uncertainty.mp.
43 decisional regret.mp.
APPENDIX A 44 (decision* adj3 satisf*).mp.
45 exp Mental Health/
SEARCH STRATEGIES USED
46 Behavioral Symptoms/
For Cochrane Central Register of Controlled Trials, Embase, MEDLINE, 47 exp Attitude to Health/
PREMEDLINE and PsycINFO, and MEDLINE Epub Ahead of Print 48 exp Patient Satisfaction/
databases (OVID): 49 exp Personal Satisfaction/
# Searches 50 ((relationship or sexual) adj3 satisfaction).mp.

1 exp Prostatic Neoplasms/ 51 self efficacy.mp.

2 (prostat* adj3 (cancer* or carcinoma* or malig* or tumo?r* or 52 conflict*.mp.


neoplas* or metastas* or adeno*)).mp. 53 (quality adj4 (life or living)).mp.
3 exp Neoplasms/ 54 exp “Quality of Life”/
4 exp Prostate/ 55 quality of life.mp.
5 3 and 4 56 (QOL or HRQOL).mp.
6 1 or 2 or 5 57 exp Social Support/
7 exp Affective Symptoms/ 58 social support.mp.
8 exp affective disorders/ 59 Interpersonal Relations/
9 affective disorders.mp. 60 exp interpersonal relationships/
10 exp Mood Disorders/ 61 exp interpersonal interaction/
11 mood*.mp. 62 social interaction.mp.
12 exp Depression/ 63 exp Personal Autonomy/
13 depress*.mp. 64 autonomy.mp.
14 exp Anxiety Disorders/ 65 exp “independence (personality)”/
15 exp Anxiety/ 66 exp Fatigue/
16 anxiet*.mp. 67 (fatigue* or tiredness or libido* or impot*).mp.
17 anxious.mp.
(Continues)
(Continues)
CHAMBERS ET AL. 887

(Continued) (Continued)

# Searches # Searches

68 exp Libido/ 4 exp Prostate/


69 sex drive.mp. 5 3 and 4
70 erectile dysfunction.mp. 6 1 or 2 or 5
71 exp Sexual Dysfunction, Physiological/ 7 exp Affective Symptoms/
72 exp Sexual Dysfunctions, Psychological/ 8 exp affective disorders/
73 exp Sexual Function Disturbances/ 9 affective disorders.mp.
74 sexual dysfunction.mp. 10 exp Mood Disorders/
75 exp Sexuality/ 11 mood*.mp.
76 sexuality.mp. 12 exp Depression/
77 exp Self Concept/ 13 depress*.mp.
78 self image.mp. 14 exp Anxiety Disorders/
79 (intimacy or wife or wives or dyad* or spous* or partner* or 15 exp Anxiety/
carer* or caregiv* or relational).mp.
16 anxiet*.mp.
80 exp marital relations/
17 anxious.mp.
81 or/7‐80
18 exp Psychosomatic Medicine/
82 6 and 81
19 exp Stress, Psychological/
83 Randomized Controlled Trial.pt.
20 psycholog*.mp.
84 Pragmatic Clinical Trial.pt.
21 psychosoci*.mp.
85 exp Randomized Controlled Trials as Topic/
22 (psycho adj soci*).mp.
86 “Randomized Controlled Trial (topic)”/
23 (intrusive adj (thinking or thoughts)).mp.
87 Randomized Controlled Trial/
24 intrusiveness.mp.
88 Randomization/
25 exp Mental Fatigue/
89 Random Allocation/
26 exp “Conflict (Psychology)”/
90 Double‐Blind Method/
27 exp Emotions/
91 Double Blind Procedure/
28 emotion*.mp.
92 Double‐Blind Studies/
29 unhapp*.mp.
93 Single‐Blind Method/
30 happiness*.mp.
94 Single Blind Procedure/
31 sad.mp.
95 Single‐Blind Studies/
32 sadness.mp.
96 Placebos/
33 anhedon*.mp.
97 Placebo/
34 melanchol*.mp.
98 (random* or sham or placebo*).ti,ab,hw.
35 fear*.mp.
99 ((singl* or doubl*) adj (blind* or dumm* or mask*)).ti,ab,hw.
36 worry*.mp.
100 ((tripl* or trebl*) adj (blind* or dumm* or mask*)).ti,ab,hw.
37 stress*.mp.
101 83 or 84 or 85 or 86 or 87 or 88 or 89 or 90 or 91 or 92 or
38 distress*.mp.
93 or 94 or 95 or 96 or 97 or 98 or 99 or 100
39 nervous*.mp.
102 82 and 101
40 nervos*.mp.
103 limit 102 to English language
41 uncertainty.mp.
104 limit 103 to yr = “2000‐current”
42 hope.mp.
Used Canadian Agency for Drugs and Technologies in Health filter for identify-
43 wellbeing*.mp.
ing randomised controlled trials (https://www.cadth.ca/resources/finding‐evi-
dence accessed 17/02/2016) 44 well being*.mp.
45 cope.mp.
46 coping.mp.
47 conflict.mp.
For Health Technology Assessments (HTA) and Database of Abstracts of 48 conflicts.mp.
Reviews of Effects (DARE) databases (Ovid): 49 exp Adaptation, Psychological/
# Searches 50 exp Adjustment/

1 exp Prostatic Neoplasms/ 51 (cognitive adj3 adjustment).mp.

2 (prostat* adj3 (cancer* or carcinoma* or malig* or tumo?r* or 52 exp Decision Making/


neoplas* or metastas* or adeno*)).mp. 53 decision making.mp.
3 exp Neoplasms/
(Continues)
(Continues)
888 CHAMBERS ET AL.

(Continued)
For Allied and Complementary Medicine (AMED) database (OVID):
# Searches # Searches
54 decisional uncertainty.mp. 1 prostatic neoplasms/
55 decisional regret.mp. 2 (prostat$ adj5 (cancer$ or Neoplas$ or malignan$)).mp.
56 (decision* adj3 satisf*).mp. 3 1 or 2
57 exp Mental Health/ 4 clinical trials/ or random allocation/
58 Behavioral Symptoms/ 5 random$.mp.
59 exp Attitude to Health/ 6 trial.mp.
60 exp Patient Satisfaction/ 7 4 or 5 or 6
61 exp Personal Satisfaction/ 8 3 and 7
62 ((relationship or sexual) adj3 satisfaction).mp. 9 limit 8 to (English and yr = “2000‐Current”)
63 self efficacy.mp.
64 (quality adj4 (life or living)).mp.
65 exp “Quality of Life”/
For CINAHL database (EBSCO):
66 quality of life.mp.
67 QOL.mp. # Searches

68 HRQOL.mp. S17 S3 AND S15 Published date: 2009‐2016; English


69 exp Social Support/ language; Exclude MEDLINE records

70 social support.mp. S16 S3 AND S15

71 Interpersonal Relations/ S15 S4 OR S5 OR S6 OR S7 OR S8 OR S9 OR S10 OR


S11 OR S12 OR S13 OR S14
72 exp interpersonal relationships/
S14 TX allocat* random*
73 exp interpersonal interaction/
S13 (MH “Quantitative Studies”)
74 social interaction.mp.
S12 (MH “Placebos”)
75 exp Personal Autonomy/
S11 TX placebo*
76 autonomy.mp.
S10 TX random* allocat*
77 exp “independence (personality)”/
S9 (MH “Random Assignment”)
78 exp Fatigue/
S8 TX randomi* control* trial*
79 fatigue.mp.
S7 TX ((singl* n1 blind*) or (singl* n1 mask*)) or TX
80 tiredness.mp. ((doubl* n1 blind*) or (doubl* n1 mask*)) or TX
81 exp Libido/ ((tripl* n1 blind*) or (tripl* n1 mask*)) or TX
((trebl* n1 blind*) or (trebl* n1 mask*))
82 libido.mp.
S6 TX clinic* n1 trial*
83 sex drive.mp.
S5 PT Clinical trial
84 erectile dysfunction.mp.
S4 (MH “Clinical Trials+”)
85 impotence.mp.
S3 S1 OR S2
86 exp Sexual Dysfunction, Physiological/
S2 TX (prostat* N3 (cancer* OR carcinoma* OR
87 exp Sexual Dysfunctions, Psychological/ malignan* or tumo#r* OR neoplas* OR metast*
88 exp Sexual Function Disturbances/ OR adeno*))
89 sexual dysfunction.mp. S1 (MM “Prostatic Neoplasms”)
90 exp Sexuality/ Used SIGN filter for identifying randomised controlled trials (http://www.sign.
91 sexuality.mp. ac.uk/methodology/filters.html#top accessed 17/02/2016)
92 exp Self Concept/
93 self image.mp.
APPENDIX B
94 relational*.mp.
FRAMEWORK FOR CATEGORISING PSYCHOSOCIAL
95 intimacy*.mp.
INTERVENTION COMPONENTS
96 wife.mp.
97 wives.mp. Education
98 dyad*.mp.
99 spous*.mp. • Psycho‐education: information or education about emotional
100 partner*.mp. impact of PCa and stress management; excludes cognitive‐behav-
101 exp marital relations/ ioural approaches.
102 carer*.mp. • Psycho‐sexual education: information or education about sexual-
103 caregiv*.mp. ity or psycho‐sexual impact of PCa or treatment.
104 or/7‐103
• PCa education: information or education about PCa, treatment,
105 6 and 104
and/or physical side effects.
CHAMBERS ET AL. 889

Cognitive‐behavioural • Social support: mentions social support generally and may also
include informal peer support in a group setting, or does not
• Cognitive restructuring: working with cognitions, challenging neg-
specify type.
ative thoughts, refocusing thoughts onto positives.
• Behaviour change: Goal setting and problem solving or behav-
Communication
ioural maintenance.
• Cognitive behavioural stress management: intervention identified • Partner: information or skill development to promote partners/
as CBSM. couples communication (eg, treatment side‐effects, intimacy),
excludes communication about sex.
Relaxation • Sexual: information or skill development to enable communication
• Relaxation: meditation or relaxation techniques (eg, progressive with partner about sex.
muscle relaxation, Qigong, breathing exercises). • Health professional: information or skill development to encour-
age communication with health professional regarding treatment
Supportive counselling or post‐treatment concerns (eg, side‐effects).

• Counselling/psychotherapy (as identified by the study author): • Communication: general interpersonal communication or commu-
nication unspecified.
counselling or therapy offered as part of the intervention including
sexual therapy, excludes cognitive‐behavioural approaches.
Decision support
• Health professional discussion: discussion with a health professional
(excludes counselling/psychotherapy, routine/standard care).
• PCa treatment: decision aid, tool or navigator to support PCa
treatment decision.
Peer support
• Sexual aids: decision aid, tool or navigator to support decision to
• Peer support: shared experience with a peer who also has PCa use erectile or other sexual aid or treatment.
(includes support groups, social support).

APPENDIX C
RISK OF BIAS ASSESSMENT OF TRIALS ADDRESSING QUESTION 1 (PATIENTS N = 56 TRIALS) AND QUESTION
2 (PARTNERS N = 14 TRIALS)

Risk of bias category Q1 N (%) Q2 N (%)

1. What was the risk of bias from the random sequence generation?
Low: Adequate (eg, computer random number generator) 20 (36) 5 (36)
High: Inadequate 2 (4) 0 (0)
Unclear: Not reported 34 (61) 9 (64)
2. What was the risk of bias from the allocation concealment?
Low: Adequately concealed (eg, central randomisation) 16 (29) 3 (21)
High: Inadequately concealed (eg, sealed envelopes) 0 (0) 0 (0)
Unclear: Concealment not reported or insufficient information to permit judgement 40 (71) 11 (79)
a
3. What was the risk of bias from incomplete outcome data ?
Low: Loss to follow‐up less than 50% and balanced across arms (<5% difference) 19 (34) 4 (29)
High: Loss to follow‐up greater than 50% or not balanced between arms or non ITT analyses 24 (43) 6 (43)
Unclear: Insufficient information to permit judgement 13 (23) 4 (29)
4. What was the risk of bias from selective outcome reporting?
Low: Study protocol available and all pre‐specified outcomes reported 7 (13) 3 (21)
High: Study protocol available and not all pre‐specified outcomes reported 14 (25) 6 (43)
Unclear: Insufficient information to permit judgement (eg, study protocol not found) 35 (63) 5 (36)
a
5. What was the risk of bias from other sources** ?
Low: Study appears free of other sources of bias 39 (70) 12 (86)
High: There is at least one important risk of bias from other sources 14 (25) 2 (14)
Unclear: Insufficient information to assess whether there is a risk of bias from other sources 3 (5) 0 (0)
a
For primary outcome
**Including differences in disease stage or follow‐up between arms, and analyses that did not consider baseline measures
ITT, intention‐to‐treat
APPENDIX D
890

ELIGIBLE TRIALS INCLUDED IN THE REVIEW ADDRESSING QUESTION 1 (PATIENTS) AND QUESTION 2 (PARTNERS)
TABLE A1 Trials comprising person‐focused interventions (N = 43: 41 patient only, 1 partner only, 1 patient and partner)
Intervention Relevant Precision Size of
Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability

Ames 57 men with Multi‐modal intervention E, CB, R, PS Wait‐list control Mental health NR −0.0 The multi‐modal intervention 100% retention at
2011 biochemical which included did not significantly (or with end of intervention
USA recurrence psychosocial PCa‐related anxiety NR 0.2 a moderate or large effect
components size) improve outcomes 97% participants attended
Median age Stress NR 0.0 ≥6 of 8 intervention
76 years Delivered by clinical sessions
psychologist, medical Mood NR −0.1
oncologist, dietician 80% rated on a 5‐point
and physiatrist PCa‐related QoL NR 0.1 scale helpfulness of
intervention as 4 (very
8 group face‐to‐face much) or 5 (extremely)
sessions over 8
weeks

Follow‐up 6 months
post‐intervention
Badger 71 men and 1. Interpersonal 1. E, SC, PS, C 2. Health Patients The health education 40% recruitment rate
2011, social network psychotherapy + education Depression P < 0.001 NR attention intervention
2013 members cancer education 2. E attention significantly improved 6% withdrew from
USA (93% female; for patient and condition for Positive affect NS NR depression, negative psychotherapy +
83% partner, partner patient and affect, stress, fatigue, education intervention
Patients + 13% family partner Negative affect P < 0.001 NR and spiritual well‐being and 9% withdrew from
partners member, 4% Delivered by nurse when compared with education attention
friend) or social worker Delivered by Stress P < 0.001 NR psychotherapy + intervention
research education intervention
Patients: 8 individual Fatigue P < 0.01 NR 86% attendance in
Men ≤6 months assistants Men in the psychotherapy
since tx telephone sessions + education intervention psychotherapy +
PCa‐related QoL NS NR
over 8 weeks Patients: 8 had significantly greater education arm;
Minimum 11% Partners: 4 individual individual improvement in positive 89% attendance in
Social well‐being NS NR
stage IV telephone sessions telephone affect if they were more education attention
over 8 weeks sessions over Spiritual well‐being P < 0.01 NR highly educated, had intervention
Patient M age 8 weeks higher PCa‐specific QoL
67 years; Follow‐up 8 weeks Partners: 4 or had more social support
Partner M age post‐intervention individual from friends
61 years telephone Men in the health education
sessions over intervention had significantly
8 weeks greater reduction in depression
if they were older, had lower
PCa‐specific QoL, were on
active chemotherapy, had
less social support or less
cancer knowledge
Men in the health education
intervention had significantly
greater reduction in stress if
they were less educated

(Continues)
CHAMBERS

(Continues)
ET AL.
TABLE A1 (Continued)

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
CHAMBERS

Partners The health education attention


Depression P < 0.05 NR intervention significantly
ET AL.

improved depression,
Positive affect NS NR fatigue, social, and spiritual
well‐being when compared
Negative affect NS NR with psychotherapy +
education intervention
Stress NS NR

Fatigue P < 0.01 NR

Social well‐being P < 0.01 NR

Spiritual well‐being P < 0.01 NR


Bailey 39 men Uncertainty management: E, CB, C, DS Usual care QoL (Cantrill's ladder) P = 0.01 NR Uncertainty management 76% recruitment rate
2004 ≤10.3 years cognitive reframing intervention significantly
USA post‐tx tailored to patient needs Mood NS NR improved QoL when 5% withdrew
decision on compared with usual from intervention
watchful Delivered by a nurse care
waiting 95% follow‐up in
5 weekly individual both arms
Stage T1‐3 (2% telephone sessions
T3)
Follow‐up ~5 weeks post‐
M age 75 years intervention
Beard 54 men Relaxation response CB, R 1. Wait‐list Anxiety NS NR No significant improvements 73% recruitment rate
2011 undergoing therapy with cognitive control in outcomes were found
USA radiotherapy restructuring (RRT) Depression NS NR when all 3 arms were 100% in Reiki and
91% ADT 2. Reiki compared RRT arms
Delivered by psychologist therapy Cancer‐related QoL NS NR completed study
Stage M0
8 weekly individual face‐to‐ Emotional well‐being NS NR 89% in RRT arm
Median age face sessions during subscale attended all 8 sessions
64 years radiotherapy period

Follow‐up 8‐12 weeks


post‐intervention
Berglund 211 men 1. Physical training + 1. R Standard care Anxiety NS NR The multi‐modal interventions 50% recruitment rate
2007 ≤6 months relaxation did not significantly
Sweden since dx 2. E, PS Depression NS NR improve outcomes 8% withdrew from physical
2. Information sessions training and physical
Stage 20% M1 3. E, R, PS training + information
3. Physical training + arms; 7% withdrew from
M age 69 years information sessions information only arm—
+ relaxation primarily because of
transport issues
Psychosocial components
for all interventions
delivered by
physiotherapist (1, 3),
nurse and urologist/
oncologist (2, 3)
891

(Continues)
TABLE A1 (Continued)
892

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
All interventions comprised
7 group face‐to‐face
sessions over 7 weeks

Follow‐up 12 months
Berry 494 men Decision support system E, C, DS + Usual care Coefficient Internet decision support 68% recruitment rate
2012, 2013 recently dx Clinic's usual Decisional P = 0.04 −3.61 units significantly reduced
USA and pre‐tx Self‐administered educational uncertainty decisional uncertainty 100% compliance
(50% had tx resources (100 unit scale) when compared with
preference at 1 individual internet session (eg, usual care Authors identified
baseline) pamphlets good acceptability
Follow‐up 6 months and links to Decisional NS NR (M 25.1 on scale
Stage T1‐2 post‐intervention reputable satisfaction of 6‐30)
websites)
Median age Decisional regret NS NR
62‐63 years
Subgroup of men who
made decision by
6 months
Total decisional NS −1.75 units
conflict (100 unit
scale)
Campo 40 men Qigong R Stretch control Cohen's d Qigong significantly improved 18% consented to eligibility
2014 <26 years (24 twice weekly Fatigue P = 0.02 NR fatigue and reduced distress assessment
USA since dx with Delivered by qigong Master group face‐to‐ (scale 0‐52) ≥ 3‐point when compared with stretch
significant and his certified face sessions) improvement control however 47% had 20% withdrew from qigong
fatigue and instructors in fatigue advanced disease in qigong arm; 35% withdrew from
sedentary score for arm compared with 82% in stretch control arm
48% ADT 24 twice weekly group 69% qigong stretch control arm
face‐to‐face sessions vs 38% 85% median rate of
61% Stage III‐IV controls attendance for qigong
Follow‐up 1 week arm; 43% for stretch
Median age post‐intervention Distress P = 0.002 −1.2 control
72 years
Carmack‐Taylor 134 men on 1. CB training to increase 1. E, PS Standard care Mental health NS NR For the outcomes of depression 64% recruitment rate
2006, 2007 ADT for next physical activity +30 and anxiety, there were
USA 12 months minutes of expert 2. E, PS Anxiety NS NR significant group x baseline 4% 90 minutes E + PS
speaker or facilitated level interactions indicating and 3% controls
M age 69 years discussion Depression NS NR that men with high rather withdrew
than low baseline levels of 70% mean attendance rate
12% depressed 2. 90 minutes of expert Self‐esteem NS NR depression (P = 0.02) or anxiety for 90 minutes E + PS;
requiring speaker or facilitated (P = 0.002) were more likely to ~82% attended at least
clinical discussion benefit from either of the 2 50% of sessions
evaluation interventions
All interventions delivered by
a group facilitator who was
supervised by a licenced
clinical psychologist

All interventions comprised


21 group face‐to‐face
sessions over 6 months
CHAMBERS
ET AL.

(Continues)
TABLE A1 (Continued)

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
CHAMBERS

Follow‐up 6 months
post‐intervention
ET AL.

Chabrera 142 men with Decision aid E, C, DS Usual care Decisional conflict P < 0.001 Difference in Decision aid significantly 100% recruitment of
2015 localised change reduced decisional eligible men
Spain disease pre‐tx Self‐administered from conflict when compared
baseline with usual care 84% intervention and
M age 69 years Individual printed score 82% control had
−24.4 (100‐ follow‐up
Follow‐up 3 months point scale)
post‐baseline
Chambers 740 men with Telephone psycho‐ E, CB, R, DS Usual care Cancer‐specific NS NR For a subgroup of participants 82% recruitment rate
2013 localised educational intervention distress who were younger with
Australia disease pre‐tx higher education levels, At 6 months post‐tx,
Delivered by nurse Decisional NS NR the psycho‐educational 7% withdrawn in
M age 63 years counsellors uncertainty intervention significantly intervention arm;
improved mental health 5% withdrawn in
5 individual telephone PSA anxiety NS NR (P = 0.04) and cancer‐ control arm
sessions: 2 pre‐tx, and specific distress
at 3 weeks, 7 weeks Mental health NS NR 100% median rate
(P < 0.008)
and 5 months post‐tx of intervention
Well‐being NS NR attendance

Follow‐up 24 months post‐tx Sexual bother NS NR

Chambers 189 men with 1. Mindfulness‐based 1. E, CB, R, PS 2. Minimally Psychological NS NR MBCT did not significantly 46% recruitment rate
2017 metastatic cognitive therapy (MBCT) enhanced distress improve outcomes
Australia disease and/or 2. E usual care compared with minimally 14% withdrew from MBCT
castration‐ Delivered by health Cancer‐specific NS NR enhanced usual care arm and 6% withdrew from
resistant professionals with Self‐ distress minimally enhanced
biochemical oncology experience and administered usual care arm
progression professional training in PSA anxiety NS NR
99% had received MBCT Individual CD 30% attended all 8
and PCa‐specific NS NR MBCT sessions
ADT
8 weekly group information QoL
M age 71 years teleconference 72% of 61 men who
sessions completed a satisfaction
40% significant survey rated intervention
baseline distress as very to extremely
Follow‐up 9 months post‐ helpful
baseline
Daubenmier 93 men on active Multi‐modal lifestyle R, PS Usual care Mental health NS NR The multi‐modal intervention 51% recruitment rate
2006; surveillance intervention including did not significantly
Frattaroli 1 hour/day stress Stress NS NR improve outcomes Mean self‐reported
2008 Stage T1‐T2 management practice programme adherence
USA Sexual function NS NR 95% at 24 months
M age 66 years Deliverer of intervention
NR 91% intervention and
86% control completed
Introduced at 1‐week 12‐month post‐
residential retreat baseline assessments

(Continues)
893
TABLE A1 (Continued)
894

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
Weekly group face‐to‐face
sessions ongoing
APPENDIX C

Follow‐up 24 months post‐


baseline
Davison 324 men recently 1. Individualised decision 1. E, DS 2. Generic Decisional NS NR Individualised decision 86% recruitment rate
2007 dx and support decision conflict support intervention did
Canada considering tx 2. E support not significantly improve 100% compliance
Self‐administered decisional conflict when
Stage T1‐T2 Self‐ compared with generic 91% individualised
1 individual interactive administered decision support intervention and 90%
M age 62 years computer session generic intervention
1 individual post‐intervention
Follow‐up 4‐6 weeks post‐ video session follow‐up
baseline (after decision
made) Mean total rating of
satisfaction with
preparation in decision
making was 2.80 for
individualised arm and
2.67 for generic arm.
The individualised
intervention was rated
higher in helping
considering pros and
cons and communicating
opinions
Diefenbach 91 men 4‐6 weeks 1. Prostate Interactive 1. E, DS 2. Control Confident about P = 0.02 NR The interactive education 75% recruitment rate
2012 since dx who Educational System (PIES) Asked to read tx choice intervention improved
USA had not made with or without tailoring 2. E Standard confidence about tx 100% compliance
a tx decision to patient's information National Prefer more time NS NR choice and reduced
seeking style (combined Cancer to decide preference for more 82% PIES with tailoring, 75%
Stage T1‐T2 results from both PIES arms) Institute information when PIES without tailoring and
booklets on Prefer more P = 0.02 NR compared with printed 79% controls had post‐
M age 62 years Self‐administered PCa for information information (however, intervention follow‐up
45 minutes baseline levels of confidence
1 individual internet/CD‐ Feel informed NS NR Mean rating of helpfulness in
about tx choice were
ROM session Self‐ not measured) decision making was 4.29 for
administered tailored PIES, 4.10 for non‐
Follow‐up immediately tailored arm and 1.79
post‐intervention 1 individual for control, scored 1 (not at
booklet all) to 5 (very much)
Dieperink 161 men 4 weeks Individualised psychosocial SC Usual care Mental health NS NR The multi‐modal intervention 77% recruitment rate
2013 since (2 sessions) and physical did not significantly improve
Denmark radiotherapy therapy (2 sessions) Sexual QoL NS NR outcomes 3% withdrew from intervention;
counselling 2% withdrew from
Stage T1‐T3 control
(46% T3) Psychosocial components
delivered by radiation 90% had 100% attendance
M age 68‐69 years therapists rate
CHAMBERS

(Continues)
ET AL.
TABLE A1 (Continued)

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
CHAMBERS

2 individual psychosocial
face‐to‐face sessions
ET AL.

over 12‐14 weeks

Follow‐up 22 weeks post‐


baseline
Feldman‐Stewart 156 men with a 1. Decision aid—Information 1. E, DS 2. Decision aid— Decision regret NS NR Including values clarification 37% recruitment rate
2012 new dx and + explicit values Information exercises in a decision aid (refusal because of: knowing
Canada making a tx clarification exercises 2. E only did not significantly improve what tx preferred or not
decision decision regret when compared needing further resources/
Self‐administered Self‐ with a decision aid providing help)
Stage T1‐T2 administered information only
1 individual computerised 100% intervention completion
60% ≥ 60 years session 1 individual and immediate post‐
computerised intervention follow‐up
Follow‐up 12‐18 months session
post‐decision
Hack 425 men attending Audiotape of tx E, DS No audio‐tape of PCa‐related QoL NS NR An audiotape of radiotherapy 96% recruitment rate
2007 primary tx consultation with tx consultation tx consultation did not
Canada consultation radiation oncologist Mood NS NR significantly improve 35% of those who received
with radiation outcomes tape did not listen to it
oncologist Individual audiotape
M 83.0 for patients who listened
Stage T1‐4 (15% Follow‐up 12 weeks post‐ to the tape (0 extreme dislike‐
T3‐4) consultation 100 extreme like); 47%
rated it ≥75
M age 67 years
Hacking 123 men newly dx Decision navigation DS Usual care Decisional self‐ P = 0.009 NR Decision navigation significantly 43% recruitment rate
2013 with localised or efficacy increased decisional self‐
UK early stage Delivered by research efficacy and reduced decision 2% withdrew from intervention
disease assistants Decisional conflict NS NR regret when compared with prior to medical consultation
considering tx usual care
options and 1 individual face‐to–face or Decisional regret P = 0.04 NR At 6 months, men in the
referred to phone session, audiotape intervention arm used the
and written notes Anxiety NS NR consultation plan M 3.3 times,
urologist
the consultation summary M
Depression NS NR 3.1 times and listened to the
M age 65‐67 years Follow‐up 6 months post‐
consultation audiotape M 2.4 times
Mental adjustment to
cancer: 92% of respondents rated the
Fighting spirit NS NR intervention as very helpful
Anxiety NS NR
before the urologist
Fatalism NS NR
consultation
Huber 203 men attending Multimedia‐supported pre‐ E Standard pre‐ Difference The addition of multimedia‐ 96% recruitment rate
2013 pre‐ operative education operative Anxiety NS −0.5 support to standard pre‐
Germany prostatectomy education operative education did 100% compliance
consultation Delivered by physician not significantly improve
Delivered by Decisional confidence NS −0.3 outcomes Complete satisfaction with
M age 63 – 1 individual computer‐ physician pre‐operative education
64 years based session reported by 69% intervention
and 52% control (P = 0.016)

(Continues)
895
TABLE A1 (Continued)
896

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
Follow‐up 6‐10 hours after
pre‐operative education
Kim 152 men Specific information about E General Negative affect NS NR Providing specific information Cannot assess
2002 undergoing radiotherapy procedures information did not significantly improve
USA radiotherapy and side effects about Fatigue NS NR outcomes when compared
radiotherapy with providing general
Stage A‐C (21% Self‐administered information
stage C) Self‐
Individual audiotapes of 2 administered
M age 71 years information sessions
Individual
Follow‐up at end of audiotapes of
radiotherapy tx 2 information
sessions
Lepore 250 men ≤1 month 1. Education + group 1. E, PS Standard medical Mental health NS NR Education and group discussion 85% consented to assessment
2003; since tx started discussion care intervention significantly reduced for eligibility; 77% of those
Helgeson (attended with a family 2. E Depression NS NR sexual bother when compared eligible agreed to participate
2006 Stage T1‐3 (12.8% member or friend) with standard care
USA T3) Sexual function NS NR 67% mean attendance rate in
Education delivered by For depression, there was a both intervention arms
M age 65‐66 years urologist, oncologist, Sexual bother P < 0.01 NR significant group x self‐esteem
dietician, oncology nurse interaction indicating that men
and clinical psychologist with lower self‐esteem were more Helpfulness M 4.22 (scored
likely to benefit from either 1 not at all to 5 very)
Group discussion delivered intervention and a significant
by male clinical group x baseline depression
psychologist to patients interaction indicating that men
and by female oncology with lower baseline depression
nurse to female family levels were likely to benefit from
members education + group discussion
intervention (P < 0.05)
6 weekly group face‐to‐face
sessions For mental health, there was a
significant group x self‐esteem
2. Education only interaction indicating that men
with lower self‐esteem were
Delivered by urologist,
more likely to benefit from
oncologist, dietician,
either intervention (P < 0.05)
oncology nurse and
clinical psychologist

6 weekly face‐to‐face group


sessions

Follow‐up 12 months post‐


intervention

(Continues)
CHAMBERS
ET AL.
TABLE A1 (Continued)

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
CHAMBERS

Manne 60 female Psychosocial educational E, CB, R, C Standard psycho‐ Distress NS NR Psychosocial education groups 57% recruitment rate
ET AL.

2004 partners of groups for wives/ social care did not significantly improve (refusal because of: distance
USA men dx with partners Cancer related‐ NS NR outcomes when compared from centre, time and health
any stage of Support from a distress with standard psychosocial problems)
Partners only PCa (5% Stage Delivered by radiation social worker care
IV) oncologist, nutritionist, and referral to Relationship NS NR 11% drop‐out from intervention
clinical psychologists and a community communication and 9% from control
M age 60 years social worker mental health about cancer
professional 85% mean attendance rate for
18% clinically 6 weekly group face‐to‐face intervention
significant sessions
distress (MHI
score > 1.5 SD Follow‐up 1 month
> normative post‐ intervention
mean)

49% had IES score


> 19, ie, high
cancer‐related
distress
McQuade 66 men scheduled Qigong/Tai chi R 1. Light exercise Fatigue NS NR A qigong and tai chi programme 38% recruitment rate
2016 to undergo during radiotherapy did not
USA radiotherapy Delivered by trained qigong Delivered by significantly improve fatigue 81% intervention, 73% light
master exercise when compared with a light exercise control and 92%
Stage I‐III physiologist exercise programme or usual wait‐list control had follow‐
(21% ≥ T3a) 3 individual or group care up at end of intervention
face‐to‐face sessions per 3 individual or
M age 65 years week during group face‐to‐
radiotherapy face sessions
(6‐8 weeks) per week
during
Follow‐up 3 months radiotherapy
post‐radiotherapy (6‐8 weeks)

2. Wait‐list
control
Mishel 252 couples 1. Uncertainty 1. E, CB, C Usual care Illness appraisal/ NS NR For patients, sexual satisfaction 77% recruitment rate
2002 (% female partner management— uncertainty was significantly different
USA unclear) Patient only 2. E, CB, C between arms over time
Symptom intensity NS NR however actual effects of
Reported patient Men ≤2 weeks Delivered by nurse uncertainty management
data only since catheter Symptom number NS NR intervention were unclear
removal 8 weekly individual
following phone calls Sexual function NS NR
surgery or
≤3 weeks since 2. Uncertainty management Sexual satisfaction P = 0.02 NR
radiotherapy —Patient and support
start person

Stage T1‐3 (27% Delivered by nurse


T3)

(Continues)
897
TABLE A1 (Continued)
898

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
Patient M age 8 weekly individual (not
64 years dyad) phone calls

Follow‐up 7 months
post‐baseline
Mishel 252 couples 1. Decision navigation— 1. E, SC, C, DS Control Mood NS NR Patients in both decision 75% recruitment rate
2009 (~80% married or Patient only navigation interventions
USA partnered) 2. E, SC, C, DS Handout on Well‐being NS NR had significantly lower Helpfulness of information
Information + telephone staying decision regret scores resources rated significantly
Reported patient Men 10‐14 days calls to review content, healthy during Decisional regret P = 0.01 NR than controls (P < 0.05) higher for men in
data only pre‐tx identify/ formulate tx either tx group vs controls
consultation questions and practise
skills
Stage T1‐2b
Phone calls delivered by
Patient M age nurse
63 years
Individual self‐administered
booklet, DVD and 4
phone calls over 7‐
10 days

2. Decision navigation—
Patient and primary
support person

Intervention as for patient


only intervention
delivered to both patient
and their support person
individually (not dyad)

Phone calls delivered by


nurse

Individual/couple self‐
administered booklet,
DVD and 4 phone calls
over 7‐10 days

Follow‐up 3 months post‐


baseline
Osei 40 men ≤5 years 1. Online support 1. E, PS 2. Resource kit Mental health NS NR Online support and 5% of patients who received
2013 since dx Us TOO International US TOO information did not invitation were interested
USA website 2. E International Sexual QoL NS NR significantly improve and eligible
M age 67 years pamphlets outcomes when compared
Self‐administered Life satisfaction NS NR with printed information 58% said online support
Self‐ (Well‐being) community met all or most of
3 times per week individual administered their needs M satisfaction
internet sessions over Relationship 3.01 (scale 1‐4)
6 weeks Individual satisfaction
booklet over Positive NS NR
6 weeks Negative NS NR
CHAMBERS

(Continues)
ET AL.
TABLE A1 (Continued)

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
CHAMBERS

Follow‐up 8 weeks post‐


baseline
ET AL.

Parker 159 men 1. Pre‐surgical stress 1. E, CB, R, No meetings Mood NS NR Stress‐management and 77% recruitment rate
2009; scheduled for management sessions SC, PS with a clinical supportive care interventions
Gilts prostatectomy psychologist Cancer‐related NS NR did not significantly improve 58% stress management arm,
2013 Delivered by clinical 2. SC distress outcomes when compared 72% supportive attention
USA Stage I‐III psychologist with controls arm and 69% controls had
(12.6% stage III) Mental health NS NR 6 weeks post‐surgery follow‐
4 individual face‐to‐face up
M age 60‐61 years sessions (3 prior to Sexual function NS NR
surgery and 1 at 48 hours
post‐surgery + printed Sexual bother NS NR
materials + audiotape
Subgroup with all
2. Supportive attention measures at
baseline and
Delivered by clinical 12 months
Distress NS NR
psychologist

Marital relationship NS NR
4 individual face‐to‐face
sessions satisfaction

Follow‐up 12 months post‐


surgery
Penedo 191 men 1. 10‐week group CB stress 1. E, CB, R, PS, 2. Half‐day Cancer‐related QoL P < 0.05 NR Stress management training 56% recruitment rate for
2006; <18 months management techniques C seminar on delivered as 10 weekly sessions eligible men
Molton since tx + relaxation training stress Follow‐up 12‐ significantly improved cancer‐
2008 2. E management 13 weeks post‐ related QoL when compared with 8% withdrew from
USA Stage T1‐T2 Co‐delivered by licenced techniques baseline a single half‐day intervention 10‐week intervention
clinical psychologist and/ Same content as 6% withdrew from half‐day
M age 65 years or master's level clinical 10‐week Subgroup + additional For men who had undergone a intervention
psychology students intervention participants prostatectomy, the 10‐week
121 men who had intervention significantly improved 79% 10‐week arm and 84%
10 weekly group face‐to‐ Co‐delivered by undergone sexual function compared with the half‐day arm completed post‐
face sessions licenced prostatectomy half‐day intervention particularly intervention follow‐up
clinical 88% significant ED for men with high interpersonal
Follow‐up 12‐13 weeks psychologist M age 60 years sensitivity
post‐baseline and/or Sexual function P < 0.05 NR
master's level However, there was a difference in
clinical assessment for the 10‐week
psychology intervention (assessed 2‐3 weeks
students post‐intervention) and the half‐day
seminar (assessed 7‐8 weeks post‐
1 group face‐to‐ seminar)
face session
Penedo 93 monolingual 1. 10‐week culturally 1. E, CB, R, PS, 2. Half‐day Cancer‐related P = 0.006 NR Stress management training delivered 37% recruitment rate for
2007 Spanish sensitive group CB stress C culturally QoL as 10 weekly sessions significantly eligible men
USA speaking men management techniques sensitive improved cancer‐related QoL when
<21 months + relaxation training 2. E seminar on Sexual QoL NS NR compared with the half‐day stress 9% withdrew from 10‐week
since tx stress management training session intervention
Co‐delivered in Spanish by management
licenced clinical techniques

(Continues)
899
900

TABLE A1 (Continued)

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
Stage T1‐T2 psychologist and clinical Same content as 3% withdrew from half‐day
health psychology 10‐week intervention
M age 66 years graduate student intervention
77% 10‐week arm and 75%
10 weekly group face‐to‐ Co‐delivered In half‐day arm completed post‐
face sessions Spanish by intervention follow‐up
licenced
Follow‐up 12‐13 weeks clinical
post‐baseline psychologist
and clinical
health
psychology
graduate
student

1 group face‐to‐
face session
Petersson 118 men (~ 50% on Randomly assigned to +/‐ E, CB, R No group Anxiety NS NR For the outcome of avoidance 61% in group arm and 68%
2002 watchful individualised intervention there was a significant group x in no group arm had post‐
Sweden waiting) ≤ intervention including CB Depression NS NR coping style interaction indicating intervention follow‐up
3 months since therapy that men with monitor (cognitive
dx Cancer‐related scanning) rather than blunter
Group rehabilitation distress (cognitive avoidance) coping style
M age 71 years programme (only or + Intrusion NS NR were more likely to benefit from
individual support) which the multi‐modal intervention
included psychosocial Avoidance NS NR
(P < 0.01)
components + physical
activity

Psychosocial components
delivered by oncologist,
urologist/surgeon and
dietician (education),
psychologist and oncology
nurse (CBT) and
physiotherapist (relaxation)

8 group face‐to‐face
sessions over 8 weeks +
booster group session
after 2 months + written
information

Follow‐up 3 months post‐


intervention start

(Continues)
CHAMBERS
ET AL.
TABLE A1 (Continued)

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
CHAMBERS

Schofield 331 men starting Nurse‐led group psycho‐ E, PS, C Usual care Effect size Psycho‐educational intervention 71% recruitment rate
ET AL.

2016 radical educational consultation Anxiety NS 0.0 significantly reduced rise in


Australia radiotherapy intervention depression when compared 3% withdrew from intervention
47% high risk Depression P = 0.0009 0.1 with control arm
31% pre‐baseline Delivered by uro‐oncology 68% attended all 4 intervention
ADT nurses Distress NS 0.1 group sessions
39% salvage EBRT
4 x group face‐to‐face Sexual QoL NS 0.1
M age 67‐68 years sessions
Sessions at beginning of Sexuality needs NS 0.0
radiotherapy, mid‐
radiotherapy,
radiotherapy completion,
and 6 weeks post‐
radiotherapy +1
individual session after
week 1 group
consultation

Follow‐up 6 months post‐


radiotherapy
Siddons 60 men 6‐60 CB group intervention E, CB, R, C Wait‐list Masculine self‐ P = 0.037 NR CB intervention significantly 7% recruitment rate
2013 months since esteem improved masculine self‐esteem, (did not participate because of
Australia prostatectomy, Delivered by psychologist sexual confidence, sexual QoL and not feeling in need of
90% ED Sexual confidence P = 0.001 NR orgasm satisfaction when psychological support, work
8 group face‐to‐face compared with wait‐list control commitments, difficulties
Stage M0 sessions over 8 weeks Marital satisfaction NS NR commuting)
PSA < 0.1 ng/mL
Follow‐up 8 weeks (end of Sexual QoL P = 0.046 NR 100% intervention and control
M age 62 years intervention) had follow‐up at end of
intervention
13% moderate‐ Sexual function
severe stress, Sexual cognition NS NR
10% moderate‐ Sexual arousal NS NR
severe anxiety, Sexual behaviour NS NR
10% moderate‐ Orgasm satisfaction P = 0.047 NR
severe Drive/relationship NS NR
depression
Stefanopoulou 68 men receiving Guided self‐help CB E, CB, R, SC Usual care Adjusted CB therapy did not significantly 75% recruitment rate
2015 ADT with therapy mean improve outcomes when
UK problematic hot difference compared with usual care Compliance: 88% read either all
flushes and Self‐administered Depression NS −0.52 (69%) or more than half of
night sweats booklet (19%)
(HFNS) 4‐week individual Anxiety NS −0.32 79% used relaxation CD and
intervention (booklet and 76% practised paced
Stage 31% M1 CD) with 1 telephone call Cancer‐related QoL NS −0.97 breathing at least once a
at 2 weeks for support week
M age 69 years and guidance delivered
by a clinical psychologist 97% of both intervention and
25% > cut‐off for controls had follow‐up at end
depression Follow‐up 32 weeks post‐ of intervention
21% > cut‐off for randomisation
anxiety
901

(Continues)
902

TABLE A1 (Continued)

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability

Taylor 120 men with a 1. Decision aid— 1. E, DS 2. Decision aid— Mental health NS NR Including interactive decision tools 86% recruitment rate (refusal
2010 new dx prior to Information +3 Information in a decision aid did not because of: 9% lack of
USA tx decision interactive decision tools 2. E only Sexual function NS NR significantly improve outcomes interest, 3% no need for
when compared with a decision aid further information, 2%
Stage T1‐T2 Self‐administered Self‐ Sexual bother NS NR providing information only uncomfortable with
administered computers)
M age 65 years Individual CD‐ROM Decisional conflict NS NR
Individual CD‐ 69% information + decision
Follow‐up 1 month post‐ ROM tool intervention used CD –
baseline 42% accessed all 3 decision
tools
90% information only
intervention used CD

88% of information + decision


tool and 89% of information
only had follow‐up at end of
intervention

Mean rating of helpfulness of


CD‐ROM for both arms
combined was 60.4 on 0‐100
scale (No association found
between helpfulness rating
and group)
Templeton 58 men tx with Nurse delivered education E Usual care Prostate cancer‐ NR NR NR (no comparative results reported) 89% recruitment rate
2004 ADT booklet related QoL
UK Participant read booklet 100% compliance
42% aged 71‐ with urology nurse
80 years 97% intervention and 93%
Delivered by urology nurse controls had follow‐up

Single individual face‐to‐


face session

Follow‐up 1 month post‐


baseline
Traeger 257 Spanish 1. 10‐week group CB stress 1. E, CB, R, PS, 2. Half‐day Emotional P < 0.05 NR Stress management training delivered 52% recruitment rate
2013 speaking men management techniques C seminar on well‐being as 10 weekly session significantly
USA <18 months + relaxation training with stress improved emotional well‐being 14% withdrew from 10‐week
since tx culturally sensitive 2. E management when compared with a single half‐ intervention
seminars techniques day stress management 8% withdrew from half‐day
Stage T1‐T2 with culturally training session intervention
Co‐delivered by clinical sensitive
M age 65 years psychologist and clinical seminars 82% 10‐week arm and 84%
psychology graduate half‐day arm completed post‐
intervention follow‐up
CHAMBERS

(Continues)
ET AL.
TABLE A1 (Continued)

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
CHAMBERS

10 weekly group face‐to‐ Same content as


face sessions 10‐week
ET AL.

intervention
Follow‐up 12‐13 weeks
post‐baseline Co‐delivered by
clinical
psychologist
and clinical
psychology
graduate

1 group face‐to‐
face session
VanTol‐Geerdink 240 men who had Decision aid E, DS Usual care Decisional regret NS NR Decision aid did not significantly 88% recruitment rate
2013, 2016 not made a tx improve outcomes when
Netherlands decision Delivered by a researcher Option regret NS NR compared with usual care Compliance 100%

Stage T1‐T3a 1 individual face‐to‐face Outcome regret NS NR 94% intervention and 91%
(<12% T3) intervention + printed controls had follow‐up at
materials end of intervention
M age 64 years
Follow‐up 12 months post‐
tx completion
Victorson 43 men with low‐ 1. Mindfulness‐based stress 1. CB, R 2. Access to a PCa‐related anxiety NS NR Mindfulness‐based stress reduction 37% recruitment rate (refusal
2016 risk localised reduction training book on training did not significantly because of distance and
USA disease on 2. E mindfulness Mental health NS NR improve PCa anxiety or mental lack of time)
active Delivered by trained and health when compared with access
surveillance experienced mindfulness Self‐ to a book on mindfulness 88% of mindfulness intervention
instructor administered arm and 89% of mindfulness
M age 69‐71 years information arm had follow‐
8 weekly group face‐to‐face up at end of intervention
sessions

Follow‐up 12 months post‐


baseline
Weber 30 men ≤6 Peer support PS Usual care Depression NS NR Peer support significantly reduced 49% recruitment rate (42%
2004 weeks since sexual bother when compared non‐responders and 9%
USA prostatectomy Delivered by peer—a long Self‐efficacy NS NR with usual care refused)
resulting in term (> 3 years) PCa
urinary and survivor who had Sexual function NS NR 12% withdrew from
sexual undergone a intervention
dysfunction prostatectomy that Sexual bother P = 0.014 NR
resulted in urinary and Attendance rate 100% for
M age 58 years sexual dysfunction intervention

8 individual face‐to‐face Qualitative assessment only of


sessions over 8 weeks intervention acceptability

Follow‐up 8 weeks post‐


baseline

(Continues)
903
TABLE A1 (Continued)
904

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability

Weber 72 men ≤3 months Peer support PS Usual care Depression P = 0.03 NR The peer support intervention 53% recruitment rate
2007 a, b since dx and provided by significantly reduced depression (33% refused or did not
USA 6 weeks since Delivered by peer with long their urologist Self‐efficacy P = 0.005 NR and increased self‐efficacy respond, 14% excluded
prostatectomy term PCa survivor who had regarding adjusting after PCa when because of geographic
undergone a prostatectomy Mental health P = 0.006# NR compared with usual care location)
Stage T1‐2 at least 3 years prior to the
study and had experienced # result excluded because of odds Maximum 2 men withdrew
M age 60 years similar tx side effects as ratios of 0.0 which indicated results from study as relocated –
the participants were problematic unclear from which
group
8 Individual face‐to‐face
sessions over 8 weeks 88% mean attendance

Follow‐up 8 weeks post‐


baseline
Wootten 142 men <5 years 1. Online psycho‐ 1. E, CB, C 3. Moderated Distress P = 0.02 η2 = 0.07 The combined online psycho‐ 30% withdrew from PsychE
2015, 2016 since tx educational intervention peer online PsychE vs PsychE + F NS NR educational intervention + arm, 27% withdrew from
Australia (PsychE) 2. E, CB, PS, C forum access PsychE vs F NS NR moderated peer forum significantly PsychE + F arm and 23%
88% radical (F) PsychE + F vs F P = 0.02 NR reduced distress and decision withdrew from F only arm
prostatectomy Self‐administered 3. PS regret, and significantly improved
Self‐ PCa‐related worry NS η2 = 0.06 sexual satisfaction when compared Mean 60% of psycho‐
M age 61 years 6 individual sessions administered with moderated peer forum alone educational content
over 10 weeks Decisional P = 0.05 NR completed in PsychE
Individually regret arm and mean 57%
2. Online psycho‐ accessed over PsychE vs PsychE + F NS NR completed in PsychE +
educational intervention 10 weeks PsychE vs F NS NR
F arm
+ access to moderated PsychE + F v F P = 0.046 NR
peer online forum Mean 1‐2 forum posts/user for
(PsychE + F) Erectile function NS NR
PsychE + F intervention
Mean 2‐3 forum posts/user for
Self‐administered Masculine self‐ NS NR
F only intervention
esteem
6 individual sessions over
10 weeks
Sexual satisfaction P = 0.028 η2 = 0.045
Follow‐up 10 weeks (end of PsychE v PsychE + F NS NR
PsychE v F NS NR
intervention)
PsychE + F v F NR Difference
1.24 95%
Follow‐up 6 months CI
post‐baseline (0.25‐2.22)
Yanez 74 men with 1. CB stress management + 1. E, CB, R, PS, 2. Health Cohen's d The 10‐week CB stress management 31% recruitment rate
2015 advanced relaxation/stress C promotion Depression NS 0.5 intervention lowered depression (refusal because of: time
USA disease at dx reduction techniques attention‐ levels with a moderate effect involved or lack of interest)
who received 2. E control (HP) Cancer‐related NS 0.2 size when compared with
ADT in last Delivered by ≥ masters level distress health promotion control 66% attendance for CB stress
6 months therapist Delivered by ≥ management and 82% for HP
masters level Cancer‐related QoL NS 0.3 intervention (P = 0.04)
therapist

(Continues)
CHAMBERS
ET AL.
CHAMBERS
ET AL.

TABLE A1 (Continued)

Intervention Relevant Precision Size of


Study Participants # Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
M age 69 years 10 weekly group online 10 weekly group Mean acceptability scores for
sessions online both interventions were
sessions between liking the study
Follow‐up 6 months post‐ “quite a bit” and “a lot “
baseline
Zhang 29 men ≥6 months Social support group E, PS, C Pelvic floor Symptom distress NS NR Addition of the social 57% recruitment rate
2006, 2007 (M 19‐ + pelvic floor muscle muscle support group did not (3 withdrew because of work
USA 22 months) exercises with exercises with Illness intrusiveness NS NR improve outcomes schedules)
since biofeedback biofeedback
prostatectomy Mood NS NR 100% intervention and 87%
with post‐ Delivered by a licenced controls had follow‐up at
prostatectomy health psychologist end of intervention
urinary
incontinence 6 bi‐weekly group face‐to‐
face over 3 months
Stage I–III
Follow‐up 3 months post‐
M age 61‐62 years baseline

#Treatment is reported if ≥80% of men received it, with the exception of ADT where the percentage of men currently receiving ADT was reported. *Precision of effect and size of effect correspond to the longest reported
follow‐up. ADT, Androgen deprivation therapy; C, Communication; CB, Cognitive‐behavioural; DS, Decision Support; Dx, Diagnosis; E, Education; EBRT, External beam radiation therapy; ED, Erectile dysfunction; M,
Mean; NR, Not reported; NS, Not significant; PCa, Prostate cancer; PS, Peer Support; QoL, Quality of Life; R, Relaxation; SC, Supportive Counselling; Tx, treatment.
905
906

TABLE A2 Trials comprising couple‐focused interventions (N = 14)


Intervention Relevant Precision Size of
Study Couples# Intervention components Comparator outcomes of effect * effect * Key findings Acceptability

Campbell 30 African Partner assisted E, CB, R, C Usual care Patients Cohen's d For patients, coping skills 25% recruitment rate
2007 American couples coping skills training Mental health NS 0.0 training improved sexual
USA (83% married) for survivors and their bother with moderate 75% of dyads completed
partners Sexual QoL NS 0.3 effect size when compared intervention
Men <4 years Sexual function NS 0.3 with usual care
since tx (~93% Delivered by African Sexual bother NS 0.5 60% intervention and
prostatectomy) American doctoral level 90% control had
or start of medical psychologists Self‐efficacy NS 0.2 follow‐up at end of
watchful waiting Partner Cohen's d For partners, coping skills intervention
6 ~weekly dyadic Caregiver strain NS 0.3 intervention improved
M age years: 62 telephone sessions depressed mood with a Qualitative assessment
(patient) and Mood moderate effect size when only of intervention
59 (partner) Follow‐up ~6 weeks Anger NS 0.0 compared with usual care acceptability
post‐baseline (end of Confusion NS 0.3
Depression NS 0.5
intervention)
Fatigue NS 0.4
Anxiety NS 0.3
Vigour NS 0.4

Self‐efficacy NS 0.1
Canada 51 couples 1. Sexual 1. E, CB, C 2. Sexual Patients Couples sexual counselling 66% completed couple
2005 (100% female; counselling—couple counselling— Distress NS NR did not significantly intervention; 57%
USA married/living 2. E, CB, C patient only improve patient outcomes completed patient
together) Delivered by Sexual QoL NS NR when compared with patient only intervention
psychologist or Delivered by only sexual counselling
Men ≤60 counsellor psychologist Marital NS NR 21% withdrew because of
months since or counsellor satisfaction high marital distress, 9%
tx with ED 4 dyad face‐to‐face discomfort with explicit
57% surgery; sessions 4 individual Utilisation of NR NR sexual topics, 6% scheduling
31% radiation face‐to‐face tx for ED conflicts
therapy Follow‐up 6 months sessions Partners Couples sexual counselling
post‐intervention Distress NS NR did not significantly improve 61% attended all 4 sessions
Stage A‐C partner outcomes when
Sexual function NS NR compared with patient only
M age years: sexual counselling
65‐66 (patient) Marital satisfaction NS NR
and 61‐62
(partner)

(Continues)
CHAMBERS
ET AL.
CHAMBERS

TABLE A2 (Continued)
ET AL.

Intervention Relevant Precision Size of


Study Couples# Intervention components Comparator outcomes of effect * effect * Key findings Acceptability

Chambers 189 couples 1. Peer‐delivered 1. E, CB, Usual care Patients Patients in the peer intervention 47% recruitment rate
2015 (100% female telephone support PS, C Sexual function NS NR were 3.14 times more likely to
Australia partners) use ED tx when compared with At 6‐months post‐recruitment 8%
Delivered by PCa 2. E, CB, Sexual supportive NS NR usual care (z = 2.41, P = 0.016) peer‐delivered arm, 5%
Men with survivors SC, C, DS care needs nurse‐delivered arm and 6%
localised Patients in the nurse‐led controls withdrew because no
disease prior Recruited Sexual NS NR intervention were 3.67 longer interested
to (74%) or pre‐surgery: 8 dyadic self‐confidence times more likely to use
≤12 months (with partner) ED tx when compared 88% (8 sessions) or 100%
since telephone sessions: Masculine NS NR (6 sessions) median attendance
with usual care (z = 2.64,
prostatectomy 2 pre‐surgery +6 self‐esteem P = 0.008) for both peer‐ and nurse‐
post‐surgery over delivered interventions
M age years: Marital satisfaction NS NR
22 weeks
63 (patient) Recruited High helpfulness ratings for all
Intimacy NS NR
and 60 (partner) post‐surgery: 6 interventions (1 not at all to
dyadic (with 10 extremely) (Nurse intervention:
Use of ED tx P < 0.01 NR
partner) telephone Patient M 8.67, Partner M 8.33;
Partner Peer or nurse‐delivered Peer intervention: Patient M 7.74,
sessions over
Sexual function NS NR interventions did not Partner M 7.47)
22 weeks
significantly improve
Sexual supportive NS NR outcomes when
2. Nurse‐delivered
care needs compared with usual
telephone counselling
care
Marital satisfaction NS NR
Delivered by PCa
nurse counsellors Intimacy NS NR
Recruited
pre‐surgery: 8 dyadic
(with partner)
telephone sessions:
2 pre‐surgery +6
post‐surgery over
22 weeks
Recruited
post‐surgery:
6 dyadic (with
partner) telephone
sessions over
22 weeks

Follow‐up
12 months
post‐recruitment

(Continues)
907
908

TABLE A2 (Continued)

Intervention Relevant Precision Size of


Study Couples# Intervention components Comparator outcomes of effect * effect * Key findings Acceptability

Couper 62 couples Cognitive CB, SC Usual care Patients Cognitive existential 18% consented to
2015 (100% female existential couple Cancer‐related NS NR couple therapy did not assessment for eligibility
Australia spouses) therapy distress significantly improve
outcomes for patients 7% dyads withdrew because
Men ≤12 Delivered by Distress NS NR of unacceptability of programme
months mental health
post‐dx professionals Well‐being NS NR 100% median attendance rate

Stage T1‐3 6 weekly dyadic Relationship NS NR


(19% T3) face‐to‐face function
sessions Partner For partners, cognitive‐
Median age Cancer‐related NS NR existential couple therapy
years: 65 Follow‐up distress significantly improved
(patient) and 9 months relationship function when
61 (partner) post‐baseline Distress NS NR compared with usual care

Well‐being NS NR

Relationship P = 0.009 η2 = 0.25


function
Giesler 99 couples Post‐tx nursing E, C Standard Effect size For patients, post‐tx nursing 48% recruitment rate
2005 (96% female support care Mental health NS ‐0.1 support significantly reduced
USA spouses) with a moderate effect size Attrition rates reportedly
Delivered by Sexual function NS 0.4 cancer worry and the extent similar in both groups
Reported Men ≤2 weeks oncology nurse to which sexual dysfunction
patient post‐tx Sexual limitation P = 0.02 0.5 interfered with spousal role
data only 6 monthly activities when compared
Stage T1a‐T2c dyadic (with Sexual bother NS 0.2
with standard care
partner) sessions;
Patient M age 2 face‐to‐face Depression NS 0.2
64 years and 4 telephone
sessions Cancer worry P = 0.03 0.5

Dyadic satisfaction NS 0.4


Follow‐up 12
months post‐tx
Dyadic cohesion NS 0.1

(Continues)
CHAMBERS
ET AL.
CHAMBERS

TABLE A2 (Continued)
ET AL.

Intervention Relevant Precision Size of


Study Couples# Intervention components Comparator outcomes of effect * effect * Key findings Acceptability

Lambert 42 couples Coping skills for E, R, C Minimal Patient Difference Coping skills and relaxation 37% recruitment rate; 42%
2016 (97% married/ couples and ethical care Anxiety NS −0.28 intervention did not refused or did not respond
Australia defacto) relaxation Printed significantly improve patient (24% not interested, 7%
materials + Depression NS 0.71 outcomes when compared too busy)
Men with Self‐administered 4 telephone with minimal ethical care
early‐stage calls over Self‐efficacy NS −4.41 No withdrawals during
disease ≤4 Dyadic booklet, 2 months to intervention in intervention
months since CD and DVD + review and Mental health NS −0.05 arm
dx, and patient 2 months use of the monitor use
or partner had materials +4 telephone of materials Cancer‐specific NS NR 100% attendance rate for 91%
distress calls from a research distress (maximum) intervention arm
thermometer assistant over 2 months and 74% (maximum) control
Uncertainty NS 4.60
score ≥ 4 to review and monitor arm
use of materials NS NR
Relationship
M age years:
satisfaction
63‐64 (patient) Follow‐up 2 months
59‐60 (partner) post‐baseline NS NR
Illness appraisal
(end of intervention)
Partner Difference Partners who received coping
Anxiety NS 0.62 skills intervention had
significantly worse challenge
Depression NS 1.17 appraisal scores than partners
who received minimal
Self‐efficacy NS 2.17 ethical care
Mental health NS −0.04

Caregiver QoL NS NR

Cancer‐specific NS NR
distress

Uncertainty NS −3.51

Relationship NS NR
satisfaction

Illness appraisal
Threat NS −1.13
Challenge P < 0.05 2.94
Harm/loss NS 0.26
Benign NS 1.05

(Continues)
909
TABLE A2 (Continued)
910

Intervention Relevant Precision Size of


Study Couples# Intervention components Comparator outcomes of effect * effect * Key findings Acceptability

Manne 71 couples Intimacy‐Enhancing E, CB, SC, C Usual care Patients For a subgroup of patients 21% recruitment rate (did not
2011 (97% female; Therapy (IET) Distress NS NR with higher baseline cancer participate because of time
USA 97% spouses) concerns, the IET intervention required, or believed would
Delivered by Well‐being NS NR was predicted to significantly not benefit)
Men ≤12 therapists improve cancer concern when
months since Cancer‐specific NS NR compared with usual care 22% did not attend any sessions
dx 5 dyadic (with partner) distress (P = 0.02) (unclear if withdrew or not)
face‐to‐face sessions
Stage 1‐2 over 8 weeks Cancer concerns NS NR 73% attendance ≥80% of
sessions
M age years: Follow‐up 8 weeks Relationship satisfaction NS NR
60 (patient) post‐baseline Intervention success M 3.2
and 56 (partner) (end of intervention) Intimacy NS NR (3 quite successful, 4
Partners For a subgroup of partners with extremely successful)
Distress NS NR higher baseline cancer‐specific
distress, the IET intervention Intervention helpfulness
Well‐being NS NR was predicted to significantly M 4.2 (5 strongly agree)
improve cancer‐related distress
Cancer‐specific NS NR compared with usual care
distress (P = 0.02)
Cancer concerns NS NR For a subgroup of partners with lower
baseline relationship satisfaction
Relationship satisfaction NS NR
(P = 0.002) and intimacy (P = 0.001),
the intervention was predicted to
Intimacy NS NR
significantly improve these
outcomes compared with usual care

For a subgroup of partners


who had higher baseline levels
of relationship satisfaction
(P = 0.04) and intimacy
(P = 0.02), the intervention
was predicted to significantly
reduce these outcomes
compared with usual care
McCorkle 107 couples Post‐tx nursing support for E, C Usual care Patients Post‐tx nursing support did not 7% of eligible dyads withdrew
2007 (100% female patient/partner dyad Depression NS NR significantly improve patient pre‐randomisation
USA spouses) during an 8‐week period outcomes when compared
immediately following Sexual function NS NR with usual care
Men immediately hospital discharge after Partners Partners receiving post‐tx nursing
prior to radical radical prostatectomy Depression NS NR support had significantly higher
prostatectomy distress related to sexual function
Delivered by advanced Relationship function NS NR when compared with usual care
30% depressive practice nurse (however, baseline sexual function
symptoms Sexual function P = 0.048 NR not assessed)
(patient); 25% 8 weekly dyadic face‐to‐face
(partner) sessions and 8 weekly
telephone calls (16
contacts over 8 weeks)
Follow‐up 6 months
post‐surgery
CHAMBERS

(Continues)
ET AL.
TABLE A2 (Continued)

Intervention Relevant Precision Size of


Study Couples# Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
CHAMBERS

Northouse 235 couples Supportive education E, R, C Standard Patients Effect size Supportive education did 69% recruitment rate
2007 (100% female for couples care Mental health NS not significantly improve (7% refused intervention
ET AL.

−0.1
USA spouses) Targeted at disease patient outcomes or result assignment; 5% did not
phase and tailored Cancer‐related NS 0.0 in a moderate or large effect complete intervention
Men ≤2 months to the needs of QoL size when compared with 1% refused control
since dx and each couple standard care assignment)
60% new dx; Illness appraisal NS 0.0
14% detection Delivered by 87% intervention and 92%
of biochemical masters‐prepared Uncertainty NS 0.0 control had follow‐up at
recurrence; nurses end of intervention
Hopelessness NS 0.0
21% metastatic
disease 5 bi‐weekly dyadic
Self‐efficacy NS −0.1
sessions: face‐to‐face
M age years: (3) and telephone
Symptom distress NS 0.1
63 (patient) call (2)
and 59 Sexual QoL NS 0.0
(partner) Follow‐up 12 months
Partners Effect size Supportive education intervention
post‐intervention
Mental health NS −0.1 did not significantly improve
partner outcomes or result
Cancer‐related QoL NS 0.1 in a moderate or large effect
size when compared with
Uncertainty NS −0.1 standard care
Hopelessness NS −0.2 #Authors considered p < 0.01 as
significant given multiple
Self‐efficacy P = 0.02# 0.3
comparisons.
Symptom distress NS −0.1

Partner's sexual
symptoms NS −0.0
causing
problems
Robertson 43 couples Couple‐based E, CB, SC, C Usual care Patient and Partner NR (no comparative 37% consented to assessment
2016 (98% female relational Usual Anxiety NR NR results reported) for eligibility; 38% of those
UK partners) psychosexual follow‐up eligible agreed to participate
treatment hospital Depression NR NR
Men dx 11 appointment 24% withdrew from intervention
weeks to 4 Delivered by Relationship function NR NR and 23% withdrew from control
years since accredited counselling
surgery and or psychotherapy Patient Sexual bother NR NR 67% attended all 6 intervention
with sexual practitioners sessions
dysfunction
6 x 3‐4 weekly dyadic
Patient M age face‐to‐face sessions
~64 years
Follow‐up 6 months
post‐intervention

(Continues)
911
TABLE A2 (Continued)
912

Intervention Relevant Precision Size of


Study Couples# Intervention components Comparator outcomes of effect * effect * Key findings Acceptability

Schover 100 couples 1. Face‐to‐face 1. E, CB, SC, Waitlist Patient and Partner NR (no comparative 28% face‐to‐face and 13%
2012 (100% female sexual counselling C, DS control Distress NR NR results reported) internet‐based arm withdrew
USA partners; 97% during intervention
spouses) Delivered by 2. E, CB, SC, Relationship satisfaction NR NR
therapist C, DS 75% face‐to‐face, 82%
Men 3 months— Sexual function and internet‐based and 90%
7 years since 5 dyadic sessions satisfaction NR NR controls followed‐up at
tx (3 face‐to‐face, end of intervention
2 telephone) over
Stage T1‐T3 12 weeks + printed
with erectile handouts of materials
dysfunction on website
(ED)
2. Internet‐based
Patient M age sexual counselling
64 years
Delivered by
therapist

Dyadic self‐
administered online
materials with email
contact and 2
telephone calls over
12 weeks

Follow‐up 12 weeks
post‐intervention
Thornton 80 patients Pre‐surgical SC, C Standard Patients Pre‐surgical communication 51% recruitment rate
2004 and 65 partners communication care Mental health NS NR enhancement intervention (47% did not participate
USA (100% female enhancement Basic did not significantly because they were too
spouses) information PCa‐related QoL NS NR improve patient outcomes busy)
Delivered by about when compared with
Men scheduled trained counsellor surgery Sexual function NS NR standard care Compliance 100%
for prostatectomy
1 dyadic (with partner) Delivered Positive affect NS NR
Stage A‐C face‐to‐face session by a nurse
(17% Stage C) Negative affect NS NR
with baseline, Follow‐up 1 year
3 weeks post‐surgery Cancer‐specific stress NS NR
post‐surgery
and 1 year Stress NS NR
post‐surgery
Relationship satisfaction NS NR
data
Partners For partners, the communication
Mental health NS NR enhancement intervention
M age years:
61 (patient) reduced stress with a
Positive affect NS NR moderate effect size when
and 57 (partner)
compared with standard care
Negative affect NS NR

Cancer‐specific stress NS NR
CHAMBERS

(Continues)
ET AL.
TABLE A2 (Continued)

Intervention Relevant Precision Size of


Study Couples# Intervention components Comparator outcomes of effect * effect * Key findings Acceptability
CHAMBERS

Stress NS partial
ET AL.

η2 = 0.12
Relationship satisfaction NS NR
Titta 57 patients Intracavernous E, SC, C Control Sexual function NS NR For patients, the intra‐ 100% intervention
2006 and partners injection‐focused Partner cavernous injection‐ and 71% controls
Italy (100% female) sexual counselling invited to Erectile function P < 0.05 NR focused sexual counselling completed study
for couples following follow‐up intervention significantly
Reported Men 20‐41 patient training in visits every Sexual satisfaction P < 0.05 NR improved erectile function, 100% intervention
patient days since PGE1‐intracavernous 3 months sexual satisfaction and and 71% controls
data only prostatectomy injections Orgasmic function NS NR sexual desire had follow‐up at
(88%) end of intervention
Deliverer of sexual Sexual desire P < 0.05 NR
Stage I‐II counselling NR
or cystectomy
(8%) who Six 3‐monthly dyadic
requested sexual face‐to‐face sessions
rehabilitation
and responsive Follow‐up
to and trained 18 months
to administer post‐surgery
PGE1‐
intracavernous
injections

Patient M age
63.5 years
Walker 27 couples Educational intervention E Usual care Patients Cohen's d For patients, educational 30% recruitment rate
2013 (100% female for couples to Intimacy NS 0.6 intervention improved at main centre (did not
Canada married/defacto) maintain intimacy intimacy and dyadic participate because of
Dyadic adjustment NS 1.0 adjustment with moderate being too busy or not
Men starting ADT Delivered by and large effect sizes interested)
researcher when compared with
M age 73 years familiar with ADT usual care 100% compliance—men
Partners Cohen's d For partners, educational in intervention arm
1 dyadic face‐to‐face Intimacy NS 0.0 intervention improved read at least part of
session + booklet dyadic adjustment with a booklet – all but 2 men
Dyadic adjustment NS 0.5 moderate effect size when read all of booklet
Follow‐up 6 months compared with usual care
post‐enrolment (however, baseline levels of
partner dyadic adjustment
differed between arms and
was not controlled for
in analyses)

#Treatment is reported if ≥80% of men received it, with the exception of ADT where the percentage of men currently receiving ADT was reported. *Precision of effect and size of effect correspond to the longest reported
follow‐up. ADT, Androgen deprivation therapy; C, Communication; CB, Cognitive‐behavioural; DS, Decision Support; Dx, Diagnosis; E, Education; EBRT, External beam radiation therapy; ED, Erectile dysfunction; M,
mean; NR, Not reported; NS, Not significant; PCa, Prostate cancer; PS, Peer Support; QoL, Quality of Life; R, Relaxation; SC, Supportive Counselling; Tx, Treatment.
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