Feasibility and Smokers' Reactions to DNA Feedback

NCT02922790 | Completed

• 1 other identifier: Pro00075612
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking

Keywords

smoker; smoking; cigarette; cessation; DNA; DNA damage; blood draw; feedback; cellular; tobacco; tobacco smoke

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (7)

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

  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

  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

  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

  Baseline to 3 months

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

  3 months

Study Arms (3)

Control

ACTIVE COMPARATOR

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

Biomarker feedback

ACTIVE COMPARATOR

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

Biomarker feedback plus

ACTIVE COMPARATOR

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

Interventions

standard health information BEHAVIORAL

Subjects will review standard health information

Control

standard health information plus info. on DNA damage BEHAVIORAL

Subjects will review standard health information and information on DNA damage

Biomarker feedback

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

Biomarker feedback plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ages 18+
• smoke \> 5 cig/day during the last week
• be open to biomarker feedback
• not actively trying to quit

You may not qualify if:

• smoker carbon monoxide level(CO \< 10 ppm)

Sponsors & Collaborators

• Duke University: lead
• Duke Cancer Institute: collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Isaac Lipkus, PhD

  Duke University School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2016
• First Posted: October 4, 2016
• Study Start: February 14, 2017
• Primary Completion: July 24, 2017
• Study Completion: July 24, 2017
• Last Updated: January 5, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)