Feasibility and Smokers' Reactions to DNA Feedback

Duke University

Status: Completed

Conditions: Smoking

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT02922790

Pro00075612

Details and patient eligibility

About

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.

Full 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).

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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39 participants in 3 patient groups

Control

Active Comparator group

Description:

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.

Treatment:

Behavioral: standard health information

Biomarker feedback

Active Comparator group

Description:

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.

Treatment:

Behavioral: standard health information plus info. on DNA damage

Biomarker feedback plus

Active Comparator group

Description:

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.

Treatment:

Behavioral: Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage