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Completed

NCT Number: NCT02922790

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.

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Key information

Conditions

Smoking Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center

Durham, North Carolina, 27701, United States

About this study

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:

  • education about harms of smoking (control group);
  • same education plus information on DNA damage and biomarker feedback (biomarker arm) without visual of damage; or
  • 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard Health Information

Behavioral

Subjects will review standard health information

standard health information plus info. on DNA damage

Behavioral

Subjects will review standard health information and information on DNA damage

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

Behavioral

Subjects will review standard health information and information on DNA damage, as well as review pictures of their cells' DNA damage

Primary outcomes

  1. Degree of participant understanding of materials, to be measured by a survey

    Time frame: week 3

    Study will measure the extent to which the biomarker information was understood, as measured by a survey

  2. Percentage of subjects who show up to the sessions

    Time frame: Week 1

    Study will collect feasibility data on how many participants come to each visit.

  3. Extent to which participants believe the feedback to be accurate

    Time frame: week 3

    The study will measure the extent to which DNA damage results would be considered accurate using a survey.

  4. Degree of participant understanding of materials, to be measured by an interview

    Time frame: Week 3

    Study will measure the extent to which the biomarker information was understood, as measured by an interview.

  5. Percentage of subjects who show up to the sessions

    Time frame: Week 3

    Study will collect feasibility data on how many participants come to each visit.

  6. Extent to which participants believe the feedback to be trustworthy

    Time frame: Week 3

    The study will measure the extent to which DNA damage results would be considered trustworthy using a survey.

  7. Extent to which participants believe the feedback to be accurate

    Time frame: Week 3

    The study will measure the extent to which DNA damage results would be considered accurate using an interview.

  8. Extent to which participants believe the feedback to be trustworthy

    Time frame: Week 3

    The study will measure the extent to which DNA damage results would be considered trustworthy using an interview.

Secondary outcomes

  1. Effect size of the changes in coherence between the control and biomarker arm from baseline to three months post-intervention on

    Time frame: Baseline to 3 months

    Change in coherence, as measured by likert scale

  2. Effect size of the change in risk appraisals between the control and biomarker arm from baseline to three months post-intervention on

    Time frame: Baseline to 3 months

    Change in risk appraisals, as measured by a scale

  3. Effect size of participant motivation to quit smoking between the control and biomarker arm from baseline to three months post-intervention on

    Time frame: Baseline to 3 months

    Change in motivation to quit, as measured by a motivation to quit scale

  4. Effect size of plans to quit smoking between the control and biomarker arm from baseline to three months post-intervention on

    Time frame: Baseline to 3 months

    Change in action planning, as measured by number of participants who have made a plan to quit smoking

  5. Effect size of mean levels of smoking between the control and biomarker arm at three months post-intervention

    Time frame: 3 months

    Mean levels of smoking at 3 months

  6. Effect size of the number of quit attempts between the control and biomarker arm at three months post-intervention

    Time frame: 3 months

    Number of quit attempts at 3 months

  7. Effect size of the quit rate between the control and biomarker arm at three months post-intervention

    Time frame: 3 months

    Quit rate at 3 months

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Duke Cancer Institute

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 4, 2016
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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