An interventional study of standard health information and standard health information plus info. on DNA damage in Smoking, sponsored by Duke University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-05.
Sponsored by Duke University · Not applicable, Interventional, and Other
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:
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).
325 studies on the registry are indexed under Smoking; 141 are open to participants now.
This study's enrollment of 39 is below the median of 117 across 250 interventional studies indexed under Smoking.
Browse Smoking studies →Duke University is the lead sponsor of 2,058 studies on the registry; 274 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 165 (81%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Behavioral: standard health information
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.
Behavioral: standard health information plus info. on 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.
Behavioral: Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage
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
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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