Clinical trial NCT02922790: Feasibility and Smokers' Reactions to DNA Feedback
Official title: Feasibility and Smokers' Reactions to DNA Feedback
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: smoker
smoking
cigarette
cessation
DNA
DNA damage
blood draw
feedback
cellular
tobacco
tobacco smoke
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Duke Cancer Institute
First posted: 2016-10-04
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to explore how feedback of cellular DNA (Deoxyribonucleic Acid) damage, as a marker of exposure to the genotoxic agents of tobacco smoke, promotes cessation.

Detailed description: The study aims to recruit 50 smokers who are not engaged in quitting. The study will involve two in-person visits. During visit 1, participants will complete a baseline survey and have their blood drawn. Approximately two weeks later, in visit 2, smokers will be randomized in a 1:2:2 ratio to one of three arms:

1. education about harms of smoking (control group);
2. same education plus information on DNA damage and biomarker feedback (biomarker arm) without visual of damage; or
3. same as arm 2 except accompanied with visuals of participants' normal and DNA damage cells. Participants in the this arm will be informed of their proportion of leucocytes showing DNA damage with pictures of their normal and damaged cells.

The goal of the analyses is to obtain effect size estimates (direction, confidence intervals) to inform if results align with hypotheses and obtain insights about reactions about the feedback (Aim 1). The study will collect feasibility data from baseline to three months (e.g., percentage who show up to the sessions, attrition).

Eligibility criteria: Inclusion Criteria:

* ages 18+
* smoke \> 5 cig/day during the last week
* be open to biomarker feedback
* not actively trying to quit

Exclusion Criteria:

* smoker carbon monoxide level(CO \< 10 ppm)

Primary outcomes:
measure: Degree of participant understanding of materials, to be measured by a survey
timeFrame: week 3
measure: Percentage of subjects who show up to the sessions
timeFrame: Week 1
measure: Extent to which participants believe the feedback to be accurate
timeFrame: week 3
measure: Degree of participant understanding of materials, to be measured by an interview
timeFrame: Week 3
measure: Percentage of subjects who show up to the sessions
timeFrame: Week 3
measure: Extent to which participants believe the feedback to be trustworthy
timeFrame: Week 3
measure: Extent to which participants believe the feedback to be accurate
timeFrame: Week 3
measure: Extent to which participants believe the feedback to be trustworthy
timeFrame: Week 3
Secondary outcomes:
measure: Effect size of the changes in coherence between the control and biomarker arm from baseline to three months post-intervention on
timeFrame: Baseline to 3 months
measure: Effect size of the change in risk appraisals between the control and biomarker arm from baseline to three months post-intervention on
timeFrame: Baseline to 3 months
measure: Effect size of participant motivation to quit smoking between the control and biomarker arm from baseline to three months post-intervention on
timeFrame: Baseline to 3 months
measure: Effect size of plans to quit smoking between the control and biomarker arm from baseline to three months post-intervention on
timeFrame: Baseline to 3 months
measure: Effect size of mean levels of smoking between the control and biomarker arm at three months post-intervention
timeFrame: 3 months
measure: Effect size of the number of quit attempts between the control and biomarker arm at three months post-intervention
timeFrame: 3 months
measure: Effect size of the quit rate between the control and biomarker arm at three months post-intervention
timeFrame: 3 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University School of Nursing
name: Isaac Lipkus, PhD
role: PRINCIPAL_INVESTIGATOR
References: