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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
39
Subjects will review standard health information
Subjects will review standard health information and information on DNA damage
Subjects will review standard health information and information on DNA damage, as well as review pictures of their cells' DNA damage
Duke University Medical Center
Durham, North Carolina, United States
Degree of participant understanding of materials, to be measured by a survey
Study will measure the extent to which the biomarker information was understood, as measured by a survey
Time frame: week 3
Percentage of subjects who show up to the sessions
Study will collect feasibility data on how many participants come to each visit.
Time frame: Week 1
Extent to which participants believe the feedback to be accurate
The study will measure the extent to which DNA damage results would be considered accurate using a survey.
Time frame: week 3
Degree of participant understanding of materials, to be measured by an interview
Study will measure the extent to which the biomarker information was understood, as measured by an interview.
Time frame: Week 3
Percentage of subjects who show up to the sessions
Study will collect feasibility data on how many participants come to each visit.
Time frame: Week 3
Extent to which participants believe the feedback to be trustworthy
The study will measure the extent to which DNA damage results would be considered trustworthy using a survey.
Time frame: Week 3
Extent to which participants believe the feedback to be accurate
The study will measure the extent to which DNA damage results would be considered accurate using an interview.
Time frame: Week 3
Extent to which participants believe the feedback to be trustworthy
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
The study will measure the extent to which DNA damage results would be considered trustworthy using an interview.
Time frame: Week 3
Effect size of the changes in coherence between the control and biomarker arm from baseline to three months post-intervention on
Change in coherence, as measured by likert scale
Time frame: Baseline to 3 months
Effect size of the change in risk appraisals between the control and biomarker arm from baseline to three months post-intervention on
Change in risk appraisals, as measured by a scale
Time frame: Baseline to 3 months
Effect size of participant motivation to quit smoking between the control and biomarker arm from baseline to three months post-intervention on
Change in motivation to quit, as measured by a motivation to quit scale
Time frame: Baseline to 3 months
Effect size of plans to quit smoking between the control and biomarker arm from baseline to three months post-intervention on
Change in action planning, as measured by number of participants who have made a plan to quit smoking
Time frame: Baseline to 3 months
Effect size of mean levels of smoking between the control and biomarker arm at three months post-intervention
Mean levels of smoking at 3 months
Time frame: 3 months
Effect size of the number of quit attempts between the control and biomarker arm at three months post-intervention
Number of quit attempts at 3 months
Time frame: 3 months
Effect size of the quit rate between the control and biomarker arm at three months post-intervention
Quit rate at 3 months
Time frame: 3 months