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Feasibility and Smokers' Reactions to DNA Feedback

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02922790
Recruitment Status : Completed
First Posted : October 4, 2016
Last Update Posted : January 5, 2018
Sponsor:
Collaborator:
Duke Cancer Institute
Information provided by (Responsible Party):
Duke University

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.

Condition or disease Intervention/treatment Phase
Smoking 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 Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Feasibility and Smokers' Reactions to DNA Feedback
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : July 24, 2017
Actual Study Completion Date : July 24, 2017

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02922790


Locations
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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27701
Sponsors and Collaborators
Duke University
Duke Cancer Institute
Investigators
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Principal Investigator: Isaac Lipkus, PhD Duke University School of Nursing

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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02922790    
Other Study ID Numbers: Pro00075612
First Posted: October 4, 2016    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
smoker
smoking
cigarette
cessation
DNA
DNA damage
blood draw
feedback
cellular
tobacco
tobacco smoke