SmokingNCT02922790
Feasibility and Smokers' Reactions to DNA Feedback
A study testing standard health information, standard health information plus info. on DNA damage and Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage in people with Smoking, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- standard health information, standard health information plus info. on DNA damage and Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2017to 24 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ages 18+
- smoke > 5 cig/day during the last week
- be open to biomarker feedback
- not actively trying to quit
Who cannot join
- smoker carbon monoxide level(CO < 10 ppm)
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27701
About this study
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.
Read the 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:
- 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).
- Conditions
- Smoking
- Being tested
- standard health information, standard health information plus info. on DNA damage, Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage
- Keywords
- smoker, smoking, cigarette, cessation, DNA, DNA damage, blood draw, feedback, cellular, tobacco, tobacco smoke
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard health informationBehavioural
Subjects will review standard health information
standard health information plus info. on DNA damageBehavioural
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 damageBehavioural
Subjects will review standard health information and information on DNA damage, as well as review pictures of their cells' DNA damage
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 3
Percentage of subjects who show up to the sessions
Study will collect feasibility data on how many participants come to each visit.
Measured: 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.
Measured: 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.
Measured: Week 3
Percentage of subjects who show up to the sessions
Study will collect feasibility data on how many participants come to each visit.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Change in coherence, as measured by likert scale
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 3 months
Effect size of the quit rate between the control and biomarker arm at three months post-intervention
Quit rate at 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2016 (estimated)
- Study start14 Feb 2017
- Primary completion24 Jul 2017
- Study completion24 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Isaac Lipkus, PhD, Principal investigator, Duke University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02922790
- Sponsor's protocol ID
- Pro00075612
- Status last verified
- Jan 2018
- First submitted
- 26 Sep 2016
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Smokers' Reactions to DNA Feedback
- ClinicalTrials.gov ID
- NCT02922790
- Acronym / sponsor ID
- Pro00075612
- Conditions
- Smoking
- Keywords
- smoker, smoking, cigarette, cessation, DNA, DNA damage, blood draw, feedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Cancer Institute
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 24 Jul 2017 (actual)
- Study completion
- 24 Jul 2017 (actual)
- First posted
- 4 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: standard health informationSubjects 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. |
| Biomarker feedback | Active comparator | Behavioral: standard health information plus info. on DNA damageSubjects 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. |
| Biomarker feedback plus | Active comparator | Behavioral: Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damageSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ages 18+
- smoke > 5 cig/day during the last week
- be open to biomarker feedback
- not actively trying to quit
Key exclusion criteria (1 listed)
- smoker carbon monoxide level(CO < 10 ppm)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard health informationSubjects will review standard health information | Behavioural | Control |
| standard health information plus info. on DNA damageSubjects will review standard health information and information on DNA damage | Behavioural | Biomarker feedback |
| Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damageSubjects will review standard health information and information on DNA damage, as well as review pictures of their cells' DNA damage | Behavioural | Biomarker feedback plus |
Primary outcome
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
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.
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.
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.
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.
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.
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.
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.
7 secondary outcomes
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
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
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
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
Effect size of mean levels of smoking between the control and biomarker arm at three months post-intervention
Time frame: 3 months
Effect size of the number of quit attempts between the control and biomarker arm at three months post-intervention
Time frame: 3 months
Effect size of the quit rate between the control and biomarker arm at three months post-intervention
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isaac Lipkus, PhD principal investigator
Duke University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing standard health information, standard health information plus info. on DNA damage and Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage in people with Smoking, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of participant understanding of materials, to be measured by a survey (time frame: week 3). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.