Feasibility and Smokers' Reactions to DNA Feedback

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Behavioral: standard health information plus info. on DNA damage; Behavioral: Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage; Behavioral: standard health information

• Registration Number: NCT02922790
• Lead Sponsor: Duke University

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).

Study Timeline

• Study First Submitted: 2016-09-26
• Study First Submitted QC: 2016-10-03
• Study First Posted: 2016-10-04
• Study Start: 2017-02-14
• Primary Completion: 2017-07-24
• Study Completion: 2017-07-24
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-04
• Last Update Posted: 2018-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Biomarker feedback	standard health information plus info. on DNA damage	Subjects will review this standardized health information, plus receive information on DNA damage along with feedback of their DNA damage. Subjects will have blood drawn and the feedback will be presented at Visit 2.
Biomarker feedback plus	Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage	Subjects will review this standardized health information, information on DNA damage along with feedback of their DNA damage, and will also will see images of their own cells with and without DNA damage. Subjects will have blood drawn and the feedback and images will be presented at Visit 2.
Control	standard health information	Subjects will review standard health information on the health consequences of smoking. Subjects will have blood drawn but it will not be tested for DNA damage.

Primary Outcome Measures

Name	Time	Method
Degree of participant understanding of materials, to be measured by a survey	week 3	Study will measure the extent to which the biomarker information was understood, as measured by a survey
Percentage of subjects who show up to the sessions	Week 3	Study will collect feasibility data on how many participants come to each visit.
Extent to which participants believe the feedback to be accurate	Week 3	The study will measure the extent to which DNA damage results would be considered accurate using an interview.
Degree of participant understanding of materials, to be measured by an interview	Week 3	Study will measure the extent to which the biomarker information was understood, as measured by an interview.
Extent to which participants believe the feedback to be trustworthy	Week 3	The study will measure the extent to which DNA damage results would be considered trustworthy using an interview.

Secondary Outcome Measures

Name	Time	Method
Effect size of the changes in coherence between the control and biomarker arm from baseline to three months post-intervention on	Baseline to 3 months	Change in coherence, as measured by likert scale
Effect size of the change in risk appraisals between the control and biomarker arm from baseline to three months post-intervention on	Baseline to 3 months	Change in risk appraisals, as measured by a scale
Effect size of participant motivation to quit smoking between the control and biomarker arm from baseline to three months post-intervention on	Baseline to 3 months	Change in motivation to quit, as measured by a motivation to quit scale
Effect size of plans to quit smoking between the control and biomarker arm from baseline to three months post-intervention on	Baseline to 3 months	Change in action planning, as measured by number of participants who have made a plan to quit smoking
Effect size of mean levels of smoking between the control and biomarker arm at three months post-intervention	3 months	Mean levels of smoking at 3 months
Effect size of the number of quit attempts between the control and biomarker arm at three months post-intervention	3 months	Number of quit attempts at 3 months
Effect size of the quit rate between the control and biomarker arm at three months post-intervention	3 months	Quit rate at 3 months

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States