QUEST Study: Results of Wave 3

Colleen Pierce RN, BSN, MSc, FNPc Morgane Swift RN, BSN, MSc, FNPc

Georgetown University School of Nursing & Health Studies

Scholarly Project, December 8, 2006

Overview of Total QUEST Study Participants

After Georgetown University IRB Approval May 1st, 2005 through May 19th, 2006 = 3 Waves of Participants in Quest Study 300 Responded to Advertisement 129 Met Criteria for Phone Screening 52 Eligible for Enrollment 47 Consented & Randomized 17 Commit Lozenges 30 Quest Cigarettes

Overview of Total QUEST Study Participants

16 Participants in Study at Visit 6 12 Participants in Study at Visit 12

6 Abstinent at Visit 12

All 6 on Quest Cigarettes

Overview of Wave 3
Sample Size
N = 16 Eight randomized to Quest cigarettes Eight randomized to Commit

Level of Education:
Graduate Level = 6 Undergraduate Level = 6 with only 1 who finished a four year degree High School = 3

Demographics:
Gender:
Male = 12 Female = 4

Ethnicity:
African American = 9 Caucasian = 6 Hispanic = 1

Age:
Mean = 47 yrs Range = 35-58 yrs

Selected Biological Baseline Data

200 180 160 140 120 100 80 60 40 20 0
MEAN

194 190 MEAN

MEAN

134 130

MEAN 83 77 80 75 MEAN

PRE Visit 4

21 19
Heart Rate SYSTOLIC DIASTOLIC WEIGHT CO

Pre and Week 4 Stress Levels

Each item addressed, Within the last week

Question1
Upset with something unexpected
Commit PRE Quest PRE Commit 4 WK Quest 4 WK

Question2 Question3 Question4

Unable to control important things

Felt nervous and stressed Dealt successfully with life hassles

Pre and Week 4 Stress Levels

Each item addressed, Within the last week

Question5
Effectively coping with life changes Ability to handle personal problems
Commit PRE Quest PRE Commit 4 WK Quest 4 WK

Question6 Question7

Felt things were going your way Question8 Felt you could not cope with lifes irritations

Pre and Week 4 Stress Levels

Each item addressed, Within the last week

Question9
Control irritations
Commit PRE Quest PRE Commit 4 WK Quest 4 WK

Question10
Felt on top of things

Question11
Angered/could not control things Question12 How often thinking about things you need to accomplish

Pre and Week 4 Stress Levels

Each item addressed, Within the last week

Question13
Control the way you spend

Commit PRE Quest PRE Commit 4 WK Quest 4 WK

your time

Question14

Felt you could not overcome difficulties

Snapshots on the FAB 4 Student FNP Participants

The GOOD
Our participants Our diverse research team members Our overall learning experience Challenges with study design Challenges of collecting biomarkers Participant life challenges to sustain retention

The BAD

The UGLY

Snapshots on the FAB 4 Student FNP Participants

Jesus*: Quest

35 year old Hispanic male relapsed tx visit 6 not prepared to quit on quit date 45 year old Black male relapsed tx visit 1 continued to smoke own brand

Edgar*: Quest

*Name changed to protect participant identification

Snapshots on the FAB 4 Student FNP Participants

Otis*: Quest

56 year old Black male dropped from study tx visit 4 couldnt keep his appointments due to work obligations 46 year old White male quit study tx visit 3 CP x 2 episodes PCP recommended stopping study

Matthew*: Lozenge

*Name changed to protect participant identification

Snapshots on the FAB 4 Student FNP Participants

Adam*: Quest

53 year old Black female family/religion major stressors relapsed tx visit 10 56 year old White male, HEAVY smoker relapsed tx visit 3 work stress

Calvin*: Quest

*Name changed to protect participant identification

Snapshots on the FAB 4 Student FNP Participants

Danny*: Quest

49 year old Black male no show tx visit 1 concerned about Marijuana use 58 year old White male dropped tx visit 1 TRIPLED his CO levels (21 to 72)

Jack*: Quest

*Name changed to protect participant identification

Snapshots on the FAB 4 Student FNP Participants

Kim*: Lozenge

35 year old Black female dropped tx visit 1 consumed 5 lozenges at once! 55 year old Black male quit tx visit 1 thought the paperwork was too tedious kept returning for the money!

Melvin*: Quest

*Name changed to protect participant identification

Snapshots on the FAB 4 Student FNP Participants

Brad*: Lozenge

53 year old White male relapsed tx visit 1 death in family 47 year old Black male relapsed tx visit 1 too excited his daughter was coming to visit

Wally*: Lozenge

*Name changed to protect participant identification

Snapshots on the FAB 4 Student FNP Participants

Lisa*: Quest

41 year old White female dropped from study visit 6 was adherent to protocol and appointments, then disappeared without a trace

*Name changed to protect participant identification

And Then There was One.

Andrew*: Quest

31 year old White male after many obstacles (HTN, tachycardia, wrecked motorcycle, job change) he made it! Only participant to complete 14 wk study and at the same time become SMOKE FREE

*Name changed to protect participant identification

Limitations to Study

Unfortunate life challenges for sample population Turn over rate of part time laboratory staff

Phlebotomy inconsistencies Topography inconsistencies

Limited resources to support more worker-friendly hours

Implications for Advanced Practice Nurses

Value of APNs in clinical trials

Having team support for coverage for RA/couselor with broken leg!

Value of interdisciplinary research team to include undergraduate students Seek opportunities to partner with others for increased sample size Sharing lessons learned

Future Research Implications for Advanced Practice Nurses

Design similar RCT using a step-down approach with Quest cigarettes (RE: .6 mg x 2 weeks, .3 mg x2 weeks, .05 mg x 2 weeks) Design study to evaluate what happens to participants who are dropped (do they continue to try to quit using other methods or skills they were taught during RCT)

Thank you from the Georgetown University School of Nursing & Health Studies FAB 4 FNPs Journey with a Tobacco Cessation Clinical Trial

Fab 4 Final Comments

Lets help everyone do it!

1-800-QUIT NOW