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Feasibility and Smokers' Reactions to DNA Feedback

2016-10-05 00:23:22 | BioPortfolio

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.

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Conditions

Smoking

Intervention

standard health information, standard health information plus info. on DNA damage, Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage

Location

Duke University Medical Center
Durham
North Carolina
United States
27701

Status

Not yet recruiting

Source

Duke University

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-10-05T00:23:22-0400

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