Feasibility and Smokers' Reactions to DNA Feedback

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Behavioral: standard health information; 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

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).

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; 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 standard health information
Active Comparator: Biomarker feedback; 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 standard health information and information on DNA damage
Active Comparator: Biomarker feedback plus; 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 and information on DNA damage, as well as review pictures of their cells' DNA damage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	week 3
Percentage of subjects who show up to the sessions	Study will collect feasibility data on how many participants come to each visit.	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.	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.	Week 3
Percentage of subjects who show up to the sessions	Study will collect feasibility data on how many participants come to each visit.	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.	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.	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.	Week 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	3 months
Effect size of the quit rate between the control and biomarker arm at three months post-intervention	Quit rate at 3 months	3 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Duke Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Actual): July 24, 2017
• Study Completion (Actual): July 24, 2017

Study Registration Dates

• First Submitted: September 26, 2016
• First Submitted That Met QC Criteria: October 3, 2016
• First Posted (Estimate): October 4, 2016

Study Record Updates

• Last Update Posted (Actual): January 5, 2018
• Last Update Submitted That Met QC Criteria: January 4, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: DNA; smoking; tobacco; feedback; DNA damage; cessation; cigarette; tobacco smoke; blood draw; smoker; cellular
• Other Study ID Numbers: Pro00075612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No