Support Care Cancer (2009) 17:1543–1552
DOI 10.1007/s00520-009-0698-z
ORIGINAL ARTICLE
Reduction of chemotherapy-induced anorexia, nausea,
and emesis through a structured nursing intervention:
a cluster-randomized multicenter trial
Patrick Jahn & Petra Renz & Joerg Stukenkemper & Katrin Book & Oliver Kuss &
Karin Jordan & Ingrid Horn & Anette Thoke-Colberg & Hans-Joachim Schmoll &
Margarete Landenberger
Received: 12 December 2008 / Accepted: 7 July 2009 / Published online: 23 July 2009
# Springer-Verlag 2009
Abstract
Objectives The purpose of this present study was to evaluate
Self-care Improvement through Oncology Nursing (SCION)
program to reduce distressing anorexia, nausea, and emesis
(ANE) in cancer patients undergoing chemotherapy.
Methods Two hundred eight patients receiving chemotherapy
with moderate to high emetogenic potential participated in a
cluster randomized trial on 14 wards in two German university
hospitals. Additionally to standard antiemetic treatment,
patients from the intervention wards received the SCION
program consisting of four modules: advisory consultation,
optimizing emesis prophylaxis, nutrition counseling, and
relaxation. Patients from the control group received standard
antiemetic treatment and standard care. Primary outcome was
P. Jahn (*) : P. Renz : M. Landenberger
Institute for Health and Nursing Science, Medical Faculty,
Martin-Luther-University Halle-Wittenberg,
Magdeburger Strasse 8,
06097 Halle, Germany
e-mail: patrick.jahn@medizin.uni-halle.de
P. Renz
e-mail: petra.renz@medizin.uni-halle.de
M. Landenberger
e-mail: margarete.landenberger@medizin.uni-halle.de
J. Stukenkemper : K. Book : A. Thoke-Colberg
University Hospital rechts der Isar, Munich Technical University,
Head Nurse Office, Ismaninger Str. 22,
81675 Munich, Germany
J. Stukenkemper
e-mail: Ene.Kukk@lrz.tu-muenchen.de
K. Book
e-mail: K.Book@lrz.tu-muenchen.de
A. Thoke-Colberg
e-mail: Pflegedirektion@lrz.tum.de
the group difference in ANE intensity assessed by Common
Terminology Criteria for adverse events (CTCAE).
Main results The SCION program did not result in a
significant difference in the incidence of ANE symptoms
as compared to standard care: mean difference on
CTCAE scale was 0.24 pts (95%CI, −1.17 to 1.66 pts;
P= 0.733). No difference could be found regarding
patients’ knowledge of side effects, self-care interven-
tions, and agency. Health-related quality of life was
significantly better for patients in the control group (mean
difference 10.2 pts; 95%CI, 1.9 to 18.5; P=0.017).
Conclusions Contrary to our expectations, the groups did
not differ in ANE intensity caused by the overall low acute
or delayed symptom intensity. Symptom hierarchy in
O. Kuss
Institute for Medical Epidemiology, Biostatistics, and Informatics,
Martin-Luther-University Halle-Wittenberg,
Magdeburger Str. 8,
06097 Halle (Saale), Germany
e-mail: oliver.kuss@medizin.uni-halle.de
K. Jordan : I. Horn : H.-J. Schmoll
University Clinic and Polyclinic for Internal Medicine IV,
University Hospital Halle,
Martin-Luther-University Halle-Wittenberg,
Head Nurse Office, Ernst-Grube-Straße 40,
06120 Halle (Saale), Germany
K. Jordan
e-mail: karin.jordan@medizin.uni-halle.de
I. Horn
e-mail: pdirektorin@medizin.uni-halle.de
H.-J. Schmoll
e-mail: hans-joachim.schmoll@medizin.uni-halle.de
1544
cancer patients alters and challenges nursing interventions
targeting the patients’ self-care strategies.
Keywords Nausea . Emesis . Chemotherapy . Self-care .
Symptom management
Introduction
Treatment and supportive care of cancer patients plays
an important role in inpatient and outpatient health care
settings. Anorexia, nausea, and emesis (ANE) once were
the most feared side effects of cancer treatment affecting
health-related quality of life (HRQoL) as well as
medical adherence [17, 25]. Despite great achievements
in antiemetic treatment, the majority of patients will
experience at least nausea and a lower degree of emesis
during their chemotherapy with a higher prevalence of
delayed compared to acute nausea or emesis symptoms
[14, 18].
Reduction of chemotherapy-induced ANE
Updated guidelines for pharmacological treatment of
chemotherapy-induced nausea and emesis have been
published by different societies [20, 28]. Besides pharma-
cological treatment, effectiveness has been also shown for
education, behavioral, or cognitive counseling [6–8, 33],
nutrition [4, 23, 26], and relaxation [11, 32]. Especially
interventions targeting improvement of self-care compe-
tence and self-care activities seem to be successful in
reducing side effects of chemotherapy [6–8]. These
interventions also have a practical relevance as patients
often have to cope with side effects on their own due to
increased outpatient chemotherapy treatment. However, the
quality of all these studies varied due to a non- or quasi-
randomized design or small samples.
Counseling and guidance, i.e., offering advice or
recommendations to actively support a patient’s decision
and behavior, are mainly the nurses’ responsibility.
However, most nurses (88%) do not feel confident and
insufficiently trained for the management of ANE [12].
This discrepancy between nurses’ needs for training in
ANE management and the improvement potentials
requires the scientific development of nursing interven-
tions for cancer patients.
The aim of this study was the evaluation of Self-care
Improvement through Oncology Nursing (SCION), a multi-
modular nursing-administered program. The program
includes counseling, optimizing emesis treatment, nutri-
tional support, and relaxation interventions to reduce ANE
symptoms in cancer patients undergoing chemotherapy
treatment. Further, objectives were to reduce information
Support Care Cancer (2009) 17:1543–1552
deficits related to ANE and to increase self-care and
HRQoL.
We compared the effectiveness of the intervention in
inpatient and outpatient settings because in regular cancer
treatment, patients are treated in both settings, depending
on diagnosis, general condition, and type of protocol.
To avoid contamination, the intervention was applied at
the level of wards, and the study was designed, conducted,
and analyzed as a cluster randomized trial.
The study is reported according to the guidelines of the
consolidated standards of reporting trials extension for
cluster-randomized controlled trials.
Patients and methods
We included oncological inpatient and outpatient wards
from two German university hospitals. The eligibility
criterion for wards was frequent treatment of oncological
patients with chemotherapeutic agents. Patients were
included if they were between 18 and 75 years, had a
cancer diagnosis, received moderate to high emetogenic
chemotherapy [16], were scheduled for at least two further
chemotherapy cycles, and signed written informed consent.
Patients were excluded if they had a limited performance
status ECOG ≥3, metastases of the CNS, or were scheduled
for a radiochemotherapy.
The study was planed, conducted, and analyzed accord-
ing to the ICH-GCP principles and was approved by the
regional ethics committee.
Intervention
The SCION program aimed to reduce the side effects
ANE, to improve patients’ knowledge related to side
effects, and to increase self-care behavior and influence
quality of life. The program was developed by a part of
the authors (PJ, PR, JS, IH, ATC, ML) based on
extensive literature review on efficient ANE symptom
management. SCION program included four modular
algorithm-based protocols summarized in a clinical
practice guideline for the professionals supplemented by
teaching booklet tailored to the patient’s need.
Figure 1 shows the structure and application of the
SCION intervention program. All patients from the
intervention group received modules 1 and 2. Module 1
“Information leaflet and advisory consultation” included a
20- to 30-min structured advisory consultation delivered
by trained oncology nurses using a 14-page education
booklet. The booklet contained information about chemo-
therapy, side effects, (non-) pharmacological treatment,
self-care actions, nutrition, and relaxation exercises. It was
developed by a part of the authors (PJ, PR, JS, IH, ATC,
Support Care Cancer (2009) 17:1543–1552
Fig. 1 SCION Program modules and application for patients in intervention group. CTx chemotherapy
ML) based on a literature review and checked for the
applied setting within a prestudy. The booklet guided the
counseling session and was handed out to each patient at
the beginning of the session. The counseling session was
held within 24 h after trial entrance. Further informational
needs were addressed in daily assessment and treated by
booster sessions. Module 2 “Optimizing emesis treatment”
was applied on a daily base during each chemotherapy
cycle. This module included an algorithm-driven feedback
process to physician to adjust emesis prophylaxis based on
a daily assessment of symptom intensity using Common
Terminology Criteria for Adverse Events (CTCAE) scale
v3.0. The physician was informed if a patient developed
significant nausea or emesis symptoms on CTCAE scale
(cutoff≥1).
Module 3 “Nutrition counseling” and module 4
“Relaxation” were applied according to intensity of ANE
symptoms. Module 3 targeted at prevention or relief of
symptoms by nutritional intervention and nutritional
counseling, encouraging the patient to counteract immi-
nent anorexia. The intervention consisted of instrumental
activities (consistence of nutrition, application) and com-
municative activities (information and education). Module
4 included a relaxation touch and massage technique.
Both modules were applied if a patient developed
significant nausea, emesis symptoms, or weight loss
according CTCAE scale (module 3 cutoff>1 and module
4 cutoff>0). The intervention period for each module was
20 to 30 min for the first session followed by booster
sessions if symptoms continued.
1545
Prior to the implementation on intervention wards, all
modules of the program were critical approved by written
review using feedback of nurses of the participating
hospitals and scientific experts.
The SCION program was administered by regular ward
nurses in the intervention group. Nurses were trained within
a 15-h course on how to carry out the intervention. The
training was organized as interactive workshops. We
refrained from administering the intervention program by
research nurses because we would like to assess our
intervention in a pragmatic way and integrated in non-
specialized nurses’ daily schedule.
Patients from the control group received standard care.
Standard care included standard pharmacological emesis
prophylaxis, but neither standardized teaching or application
of written materials nor other evidence-based treatment
protocols were given.
Primary outcome
The primary outcome was the post-intervention difference
in mean ANE intensity represented by a summative score
of four adverse events of anorexia, nausea, emesis, and
weight loss classified according to CTCAE terminology.
We used the summative score formula: ANE=2.5×
(anorexia, nausea, emesis)+3.33×weight loss, to bring
each symptom in 0 to 10 range, i.e. 0–40 pts for all for
symptoms, and giving equal weight to each of the four
symptoms. Assessment was carried out by nurses of the
participating wards on the first 5 days of two chemo-
1546
therapy cycles. The effectiveness of the intervention was
evaluated by the difference in the mean ANE score
during the first 5 days of the second chemotherapy cycle
between SCION and control group.
Secondary outcomes
Additional to symptom intensity, we assessed as secondary-
patient-reported outcomes the SCION acquired self-care
competence, through patients’ knowledge, perceived self-
care agency, used self-care activities, and their impact on
patients’ overall HRQoL.
Patient’s knowledge of chemotherapy-related side effects
and effective self-care activities were evaluated using a
100-mm visual analog scale ranging from “insufficient” to
“very good.”
Further, we assessed self-care agency using the 24-item
ASA-A scale [9]. This scale uses a Likert approach within
five response categories ranging from 1 “totally disagree”
to 5 “totally agree.” Individual items were combined into a
summative scale with 120 as the maximum score and 24 as
the minimum score.
For assessment of self-care activities due to side
effects of chemotherapeutic agents, we used the “Self-
care questionnaire for chemotherapy side effects” from
Tanghe et al. [31]. The instrument records 166 self-care
activities for 31 chemotherapy side effects, number of
activities ranging from two to 12 per side effect which
were administered in the current chemotherapy cycle.
Each self-care activity is rated for effectiveness using a
Likert approach within five response categories from 0
“not” to 4 “total.” This extensive symptom screening was
applied to allow rankings of observed ANE in context of
other distressing symptoms.
HRQoL was evaluated using the global quality of life
subscale, items #29 and #30 from EORTC QLQ C-30
version 3.0 questionnaire [2]. The questionnaire is sensitive
for HRQoL experienced during the last week.
All secondary outcomes were patient-reported and were
evaluated by differences between intervention and control
group post-intervention at the eighth day of the second
cycle (t2). All included outcome measures were approved
for sufficient validity and reliability [2, 9, 31].
Baseline data on patient demographics, current illness,
and treatment plan were obtained from each patient before
the first application of chemotherapy agents in the first
chemotherapy cycle using a standard data collection form.
Sample size
Sample size was estimated based on the t test (α=0.05) for
cluster-randomized controlled studies by Murray [24] with
an expected effect of a critical difference of 6 points (SD
Support Care Cancer (2009) 17:1543–1552
12.5), an intracluster correlation of 0.05 and a power of
80%. Based on these assumptions, a sample size of 200
study participants was calculated. To allow some moderate
dropout, 240 participants were included into the study.
Randomization
Random allocation of the wards was based on a reproduc-
ible SAS PROC PLAN code, stratified by university
hospital center, and performed externally by the Institute
for Medical Epidemiology, Biostatistics, and Informatics of
the Martin-Luther-University Halle-Wittenberg.
Implementation
Patients were recruited by the nurses of the participating
wards under the guidance of research assistants. They were
included in the trial if they met inclusion criteria and signed
informed consent. To ensure the implementation of the
intervention, quality audits were conducted in the inter-
ventions groups in both study centers based on the
guidelines of the Royal Collage of Nursing [27] and the
German network of Quality Assurance in Nursing Care.
The audit was based on an inquiry of the trained nurses
proving their knowledge from training module, nonpartic-
ipating observation of administration of SCION program,
and additional comparison of nursing records with study
documentation for 10% of all included patients.
Blinding
Nurses who administered the interventions and assessed the
outcomes were aware of group allocation due to their
participation in the training program to manage the SCION
intervention. Patients were not informed about group
assignment but might be aware of it due to unmasking
information from nurses.
Statistical methods
The statistical analysis of the primary outcome ANE was
conducted based on hierarchical models for the analysis of
cluster randomized trials [24], including a random intercept
for the respective ward. Due to our limited number of wards,
we a priori specified to statistically adjust the analysis by
covariates (age, sex, diagnose, general condition, BMI,
previous chemotherapy, emetogenic potential of chemother-
apy agents, previous chemotherapy ANE intensity at
baseline and setting [21, 29]) being significantly (P<0.1)
different at baseline. Baseline differences were judged by
simple t and Chi2 tests.
Subgroup analyses were undertaken by checking inter-
action of covariates being significant different at baseline
Support Care Cancer (2009) 17:1543–1552 1547

with intervention [30]. An intent-to-treat approach was used
for the analysis.
Results
Recruitment
Participants were recruited from July 2005 to August 2006.
They attended the hospital for chemotherapy (first and second
study cycles) at one of the study inpatient and outpatient
wards (baseline). Last follow-up assessment was the eighth
day of the second chemotherapy cycle (second study cycle).
Table 1 shows that both groups did not differ regarding
routine antiemetic treatment, age, BMI, and previous
introduction to chemotherapy. However, significant base-
line differences were found for sex, diagnoses, general
condition, emetogenic potential of administered chemo-
therapy agents, ANE intensity at baseline, and for
outpatient and inpatient treatment (Table 1). To control
the influence of these variables, they were entered as
covariates into the final analysis.
The dropout rate for patients was 38/246 (15.4%). Reasons
for dropout were discontinuing the chemotherapy, additional
radiotherapy, or decease (Fig. 2). The dropout rate was higher
in the intervention group due to slight imbalances in the
randomization. These resulted in a higher proportion of
hematological patients with more additional radiotherapies in
the intervention group which led to exclusion.
Impact of SCION on ANE intensity
No significant differences could be observed between the
intervention and control groups in the reduction of ANE

Table 1 Baseline information

Control group Intervention group P value

Wards at baseline
No. 7 7 <0.001
Inpatient 2 4
Outpatient 5 3
Size of wards <0.001
≤10 places 3 3
≤20 places 1 2
>20 places 3 2
Patient characteristics at baseline
No. 103 105
Inpatient/outpatient ratio 11/91 (10.7%) 56/49 (53.3%) <0.001
Mean age (years) 53.38 (SD 13.69) 50.52 (SD 13.21) 0.129
No. of women (%) 50 (48%) 75 (71.4%) 0.001
BMI 25.17 (SD 4.06) 25.03 (SD 4.70) 0.813
Performance status (ECOG) <0.001
0 42/101 (41.6%) 72/94 (76.6%)
1 43/101 (42.6%) 19/94 (20.2%)
2 16/101 (15.8%) 3/94 (3.2%)
Previous CTx 48/92 (52.2%) 60/95 (63.2%) 0.128
Emetogenic potential of chemotherapy agents [16] 0.005
Level 4 41/103 (39.8%) 23/105 (22.9%)
Level 5 62/103 (60.2%) 82/105 (78.1%)
No. of antiemtic treatments using NK-1 antagonists in addition 11/103 (10.7%) 21/105 (20.0%) 0.159
to 5-HT3 antagonists and steroids
Type of malignancy <0.001
Gynecologic tumors 34/99 (34.3%) 61/103 (59.2%)
Urologic tumors 5/99 (5.1%) 6/103 (5.8%)
Hematological malignancies 6/99 (6.1%) 26/103 (25.2%)
Other tumors 54/99 (54.5%) 10/103 (9.7%)
ANE intensity (summary score) 1.29 pts (SD 3.24) 0.44 pts (SD 1.66) 0.019

SD, standard deviation, pts, points; CTx, chemotherapy

1548 Support Care Cancer (2009) 17:1543–1552

Fig. 2 Participant flow. CTx

chemotherapy Wards assessed for eligibility

Enrolment
(n =14)

Refused to participate
(n = 0)

Randomized (n = 14)

Allocation
Allocated to Allocated to SCION
Standard Care (n = 7) Program (n = 7)

Included patients Included patients

(n = 116) (n =130)

Drop out (n = 13) Drop out (n =25)

Follow up

Discontinued CTx n = 6 Discontinued CTx n = 6

Withdrew n = 0 Withdrew n = 3
Dead n = 4 Dead n = 1
Radiotherapy n = 3 Radiotherapy n = 11
Other* n = 0 Others* n = 4

Analyzed (n =103) Analyzed (n = 105)

ANE intensity (CTCAE) n = 57 ANE intensity (CTCAE) n = 102
HRQoL n = 99 HRQoL n = 99
Analyzed

Knowledge side effects n = 87 Knowledge side effects n = 81

Knowledge self care n = 86 Knowledge self care n = 81
Self care competence n = 98 Self care competence n = 101
Self care activities n = 83 Self care activities n = 87
Self care effectiveness n = 81 Self care effectiveness n = 86

* e.g. double inclusion

Table 2 Effects of SCION program

Variable Control no. Intervention no. ICC coefficient Adjusted mean difference Adjusted χ2 Statistic P value
(95%CI)

No. of wards 7 7
No. of patients 103 105
Primary outcome
ANE (CTCAE) 55 81 <0.01 0.24 pts (−1.17 to 1.66) 0.34 0.733
Secondary outcomes
Knowledge side effects 83 71 0.11 1.41 mm (−13.77 to 16.59) 0.22 0.830
Knowledge self-care 83 71 0.11 −6.15 mm (−24.32 to 12.02) -0.89 0.416
activities
Self-care competence 95 91 0.12 0.34 pts (−7.26 to 6.59) -0.11 0.915
Self-care activities 79 71 0.13 −4.86 act (−29.46 to 19.74) -0.47 0.655
Self-care effectiveness 77 71 0.09 −13.28 pts (−63.32 to 36.76) -0.67 0.533
HRQoL 95 89 <0.01 10.20 pts (1.86 to 18.54) 2.41 0.017

act actions, ICC intracluster correlation, pts points, SD standard deviation

Support Care Cancer (2009) 17:1543–1552 1549

Table 3 ANE intensity

Day of CTx Control group Intervention group

Total no. ANE CTCAE mean (SD) Total no. ANE CTCAE mean (SD)

Pre-1st CTx-cycle 99 1.30 pts (3.29) 93 0.50 pts (1.76)

1 (acute ANE) 55 1.42 pts (3.20) 87 0.66 pts (2.68)
2 28 2.77 pts (4.58) 37 0.88 pts (2.17)
3 16 2.66 pts (3.09) 35 1.08 pts (2.27)
4 10 2.25 pts (2.49) 34 0.98 pts (2.32)
5 10 1.25 pts (1.32) 34 1.00 pts (2.35)
Pre-2nd CTx-cycle 98 1.29 pts (2.55) 92 0.54 pts (1.69)
1 (acute ANE) 55 1.08 pts (2.65) 90 1.04 pts (2.56)
2 25 1.60 pts (2.78) 35 0.60 pts (1.83)
3 14 1.96 pts (2.44) 32 1.20 pts (2.37)
4 12 2.08 pts (2.58) 32 1.35 pts (2.34)
pts points, SD standard devia- 5 11 2.27 pts (3.25) 28 1.67 pts (2.57)
tion, CTx chemotherapy

symptoms (Table 2). Mean difference in ANE intensity
between control and SCION groups was 0.24 pts (95%CI,
−1.17 to 1.66; P=0.733).
A maximum ANE intensity of 40 pts would have been
possible, but patients in our trial showed 1.29 pts (SD 3.24)
at baseline for the control group and 0.44 pts (SD 1.6) for
the intervention group. After the second study cycle, ANE
intensity reached 2.27 pts (SD 3.25) in the control group
compared to 1.67 (SD 2.57) in the intervention group
(Table 3 and Fig. 3).
Impact of SCION on knowledge, self-care, and HRQoL
No group difference could be found regarding patients’
knowledge of chemotherapy side effects and knowledge of
self-care activities, as well as regarding self-care compe-
tence, activities, and their effectiveness.
HRQoL was significantly better for patients in control
group with a mean difference of 10.20 pts (95%CI, 1.86 to
18.54; P=0.017).
Ancillary analyses
Subgroup analysis results indicated that there were no
statistically significant interactions between ANE intensity
and the covariates (Table 4).
Bringing the observed ANE symptoms assessed with
the Tanghe questionnaire [31] in a hierarchy of most
frequent side effects of chemotherapy, nausea symptoms
remained at sixth rank with 95/206 (46.1%) behind

Fig. 3 Symptom intensity during 3 Mean Nausea Control

study cycles: summative score
Mean Nausea SCION
ANE and single-score nausea and
Mean Emesis Control
emesis 2,5
Mean Emesis SCION
Mean ANE Control
2 Mean ANE SCION
Mean CTCAE score

1,5

0,5

0
0d - 1d 2d 3d 4d 5d 0d - 1d 2d 3d 4d 5d
1st 2nd
Cycle Cycle
1550 Support Care Cancer (2009) 17:1543–1552

Table 4 Interaction test ANE and covariates

Control no. Intervention no. P value

Inpatient/outpatient 57 102 0.743

No. of women 57 102 0.813
General condition (ECOG) 57 91 0.911
Emetogenic potential of chemotherapy agents [16] 57 91 0.593
ANE intensity (CTCAE Scale) 57 91 0.220
Mean ANE intensity (CTCAE Scale) first 5 days in first study cycle 57 96 0.410

fatigue, hair loss, or mood alteration and emesis at the Moreover, if ANE symptoms occurred, intensity
25th rank 38/206 (18%; Table 5). remained low. The observed shift from baseline to the
second study cycle is marginal and equivalent to the shift
from (0) no nausea to (2.5) nausea with loss of appetite
Discussion without alteration in eating habits on CTCAE scale.
The Antiemetic Subcommittee of the Multinational
Our initial hypothesis was that a structured intervention for Association of Supportive Care in Cancer (MASCC)
oncology patients receiving chemotherapy with moderate or recently noted that the use of antiemetic therapy can
high emetogenic potential would significantly decrease prevent vomiting in 70–80% of patients, whereas the
ANE intensity. Contrary to our expectations, this hypoth- control of nausea remains suboptimal [28]. Our study
esis is not supported by our study results. confirms the prevention of acute and delayed emesis, and
However, the result did not reflect whether the SCION contrary to the MASCC statement, acute and delayed
program was simply not effective or whether it did not nausea in patients with moderate or high emetic risk
show its effectiveness due to the low ANE incidence and chemotherapy could also be prevented. However, the
intensity. A main result of our trial is that ANE was not as MASCC guidelines were written before the wide use of
severe as expected. The high incidence up to 60% for acute NK-1 antagonists.
and delayed nausea in oncology patients receiving chemo- Side effects such as fatigue, hair loss, sleeping distur-
therapy from previous studies [14, 17, 18] could not be bance, and dry mouth seem to be more disturbing for
affirmed. One reason might be the integration of the NK-1 patients receiving chemotherapy treatment (Table 5). Our
antagonist aprepitant in the antiemetic prophylaxis in our results confirm that alterations in symptom hierarchy,
study in contrast to the results of studies in the cited nausea, and emesis are no longer most distressing side
literature which were conducted before the introduction of effects of chemotherapy [3, 10, 13, 15]. Reasons for the low
NK-1-receptor antagonists. ANE prevalence and intensity might be due to the high
supply level of a university hospital specialized on cancer
Table 5 Chemotherapy-induced side effects
treatment, including antiemetic prophylaxis according to
the latest guidelines [20, 28].
Baseline Post-intervention Thus, the effectiveness of nursing interventions to reduce
chemotherapy-induced ANE and increase HRQoL [5, 7, 21,
Frequency (%) Frequency (%)
22] could not be confirmed by our data. In fact, we must
Fatigue 1 110/169 (65) 1 145/206 (70) consider that SCION affected HRQoL negatively. Ballatori
Hair loss 2 104/169 (62) 2 135/206 (66) and Roila noted correlations between intensity of
Mood alteration 3 77/169 (46) 8 84/206 (41) chemotherapy-induced ANE and HRQoL, i.e., high symp-
Sleeping disturbance 4 76/169 (45) 3 116/206 (56) tom intensity reduces HRQoL [5]. But SCION and control
Dry mouth 5 66/169 (39) 5 99/206 (48) group did not differ in their ANE level and, for that reason,
Dysgeusia 6 65/169 (38) 4 104/206 (50) should not show significant differences in HRQoL. Thus,
Nausea 7 65/169 (38) 6 95/206 (46) low HRQoL in SCION group might be related to unmet
Loss of appetite 11 57/169 (34) 7 90/206 (44) patients’ counseling needs. If ANE is less important in
Pain 15 51/169 (30) 13 77/206 (37)
patients’ perspective, indicated by low intensity and rank in
Weight loss 16 51/169 (30) 16 71/206 (34)
symptom hierarchy, SCION, actually tailored to nausea and
Emesis 19 35/169 (21) 25 38/206 (18)
emesis symptoms, did not respond to problems with higher
priority, e.g., fatigue, hair loss, or overall coping with
Support Care Cancer (2009) 17:1543–1552
cancer diagnosis and treatment. This might have had a
negative impact on HRQoL. These results indicate that
nursing intervention programs should address side effects
more comprehensively.
A further reason for better HRQoL in control group might
be the higher number of outpatients. Outpatients are likely to
receive more social and emotional support in a familiar
environment and could, therefore, maintain a better HRQoL
[19]. Finally, we must consider that intensified counseling
and information leaflets regarding chemotherapy-induced
side effects might have had a sensitization effect on patients
in the SCION group. Thus, they felt more stressed by
developed and expected side effects expressed through lower
HRQoL.
Several methodological aspects of our study deserve
further discussion. This trial used random group allocation
and, thus, enabled valid estimates of the study effect
minimizing potential sources of bias. Contrary to other
studies, which used research nurses to administer interven-
tion [7], the SCION program was integrated in nurses’ daily
working schedule and applied through regular ward staff,
i.e., the intervention was tested under “real world” circum-
stances, and the results can be generalized to similar
settings. Furthermore, the intervention was implemented
on 14 wards in two different hospitals which balanced out
specific organizational features.
However, several limitations of this trial should be
noted. First of all, the short duration of hospital stay for
inpatients or outpatients resulted in short contact periods to
administer the intervention. After the second day of the first
study chemotherapy cycle, only 78/208 (37.5%) patients
remained in hospital and, on the fifth day, only 53/208
(25.0%). The second study chemotherapy cycle affirmed
this short duration with 71/208 (34.1%) and only 47/208
(22.6%) on the fifth day. Reduced duration of hospital stay
and reduced time to administer the structured intervention
might have reduced its efficacy.
In conclusion, these results demonstrate that the SCION
program did not result in significant reduction of ANE
intensity. One reason might be the low incidence of acute or
delayed symptom intensity. Our results confirmed alter-
ations in symptom hierarchy and the perception that acute
and delayed nausea and emesis are no longer most
distressing side effects in patients with moderate or high
emetic risk chemotherapy.
From our results, we draw the following practical
implications. The effect of the SCION program to reduce
acute and delayed CINE is limited. The main cause is the
emetogencity of the chemotherapeutic agents, and the main
way to prevent or reduce symptoms is proper use of
pharmacological agents available now [15]. However, behav-
ioral intervention methods may have more impact within the
management of anticipatory nausea and emesis [1, 11].
1551
Furthermore, future intervention programs should con-
sider reduced time frames to administer information or
counseling offers within unmediated nurse and patient
contacts due to reduced duration of hospital stays or
outpatient settings. Tailored information or counseling
programs targeting self-care ability should continue into
the ambulant sector.
Further research is needed to investigate the impact of
information, outpatient treatment, and patients’ expect-
ations on the HRQoL. Changes of chemotherapy-induced
nausea within overall symptom hierarchy should be
approved within larger samples.
Acknowledgements Funding for this research was provided by the
German Federal Ministry of Education and Research (BMBF)—Grant
No. 01GT0301.
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