Smoking
Conditions
Keywords
smoker, smoking, cigarette, cessation, DNA, DNA damage, blood draw, feedback, cellular, tobacco, tobacco smoke
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).
Interventions
BEHAVIORALstandard health information
Subjects will review standard health information
BEHAVIORALstandard health information plus info. on DNA damage
Subjects will review standard health information and information on DNA damage
BEHAVIORALSubjects will review standard health information and information on DNA damage, plus pictures of their DNA damage
Subjects will review standard health information and information on DNA damage, as well as review pictures of their cells' DNA damage
Sponsors
Duke Cancer Institute
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 1 | 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 a survey. |
| 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 a survey. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 quit rate between the control and biomarker arm at three months post-intervention | 3 months | Quit rate at 3 months |
| 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 |
Countries
United States
Outcome results
None listed