- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05641974
Effect of Helpers Program On-line Training on Smoking Relapse and Social Networks
March 13, 2024 updated by: University of Colorado, Denver
The purpose of this study is to assess the effect of the Helpers Stay Quit training on abstinence over time of newly abstinent smokers, and on the interactions they have with their personal network related to smoking and smoking cessation.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
Despite major gains in smoking cessation treatment, over half of recently quit smokers will relapse within the first year.
To date, relapse prevention interventions have focused on the newly abstinent smoker ("abstainer"), and not attempted to directly or indirectly influence the abstainer's personal network, e.g. by helping the abstainer influence others in their personal network to quit.
Personal networks exert powerful effects on initiating and maintaining smoking behavior, and can facilitate maintaining abstinence or trigger relapse.
A "help others" intervention that seeks to increase the abstainer's ability to influence smokers in their personal network to quit - thereby creating a social environment more supportive of long-term abstinence - may have a beneficial effect on relapse.
The Helpers Stay Quit intervention encourages abstainers to reinforce their own abstinence through helping others quit, and to proactively influence their personal network to be more conducive to long-term smoking abstinence.
Helpers Stay Quit teaches abstainers how to encourage other tobacco users to quit and avoid relapse through a non-confrontational "helping conversation" that encourages quitting and use of evidence-based cessation aids (e.g.
Quitlines, cessation medications) without confrontation and nagging.
The investigator hypothesizes that Quitline abstainers exposed to Helpers Stay Quit will have higher 30-day and 7-day point prevalence abstinence than those receiving Quitline follow-up usual care, and that the effect of Helpers Stay Quit may be mediated by personal network characteristics.
To test this hypothesis, the investigator proposes a pragmatic randomized controlled trial with embedded mixed-methods personal network study to assess the effect of Helpers Stay Quit training on proportion and duration of abstainers' abstinence over time, and on abstainer's personal network interactions related to smoking and smoking cessation.
Metrics derived from the personal network study will be used for mediational analyses of overall, and gender-based effects of Helpers Stay Quit on smoking relapse.
Study Type
Interventional
Enrollment (Estimated)
940
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Anschutz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 years or older
- Abstinent from smoking for between 14 and 60 days
- Primary tobacco use is cigarettes
- Has access to Internet via computer or mobile device
- Self-described proficiency with English
- Willing and able to send/receive weekly text messages using personal mobile phone plan
- Will allow Quitline to share their client data with research team
- Willing to complete online surveys at baseline, 3-, 6-, 9- and 12 months
- Willing to self-collect dried blood spot and send back to research team
- If assigned to Helpers Stay Quit condition, willing to complete training within 14 days
- If selected, willing to participate in qualitative interview
- Willing to forego any other training for tobacco cessation intervention/support (i.e., to become a cessation counselor/facilitator or support person, e.g., 'quit buddy') for the duration of their study enrollment
Exclusion Criteria:
- Any prior exposure to Helpers training or other cessation training in the previous 2 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Helpers Stay Quit Training
Research participants randomized to the experimental arm will receive the on-line Helpers Stay Quit training which provides training on how to help others quit smoking.
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The Helpers Stay Quit training emphasizes a tobacco-user centered, non-confrontational approach to encouraging others to quit smoking.
Helpers Stay Quit trainees learn how to offer a 4-step "helping conversation".
The four steps of a helping conversation parallel the 4 core training modules of Helpers Stay Quit (Awareness, Understanding, Helping, Relating).
A key learning objective of Helpers Stay Quit, is for Helpers to learn how to manage their own expectations for the process and outcome of a helping conversation (e.g.
Helpers are taught that they cannot "make" anyone quit, but they can offer non-judgmental support, and information about effective cessation aids).
Consequently, Helpers are taught to manage their own behavior when helping others (e.g.
avoiding nagging or pushing a tobacco-user to quit).
The helping conversation focuses on encouraging behavior change that is aligned with the tobacco user's current willingness/readiness to take any action toward quitting.
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No Intervention: Usual Care
Research participants randomized to the arm without intervention will receive Quitline usual care.
They will be contacted for assessment of abstinence at 7 months after enrollment in services.
If the participant has relapsed, the Quitline will attempt to re-engage the participant in cessation services (telephone and/or web-based).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7-day and 30-day abstinence from using combustible tobacco at 6 months post-randomization
Time Frame: Self-reported data collected at 6 months post-randomization
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Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
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Self-reported data collected at 6 months post-randomization
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7-day and 30-day abstinence from using combustible tobacco at 12 months post-randomization
Time Frame: Self-reported data collected at 12 months post-randomization
|
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
|
Self-reported data collected at 12 months post-randomization
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7-day and 30-day abstinence from using combustible tobacco at 3 months and 9 months post-randomization
Time Frame: Self-reported data collected at 3- and 9-months post-randomization
|
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
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Self-reported data collected at 3- and 9-months post-randomization
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Time to first relapse
Time Frame: Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization
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Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
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Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization
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Number, timing, and duration of relapses
Time Frame: Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization
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Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
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Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization
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Number of helping conversations offered
Time Frame: Weekly data collected months 1-6; bi-weekly data collected months 7-12; data collected at 3-, 6-, 9-, and 12-months post-randomization
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Participants report the number of helping conversations (if any) offered within the specified timeframe.
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Weekly data collected months 1-6; bi-weekly data collected months 7-12; data collected at 3-, 6-, 9-, and 12-months post-randomization
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Biochemical confirmation of abstinence at 6 and 12 months on a subsample
Time Frame: Data collected and 6- and 12-months post-randomization
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Participants who report abstinence at 6- and 12-months (and no other exposure to nicotine) receive a dried blood spot kit which is returned and tested for cotinine.
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Data collected and 6- and 12-months post-randomization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Myra Muramoto, MD, MPH, University of Colorado School of Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 12, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
February 28, 2027
Study Registration Dates
First Submitted
November 21, 2022
First Submitted That Met QC Criteria
November 29, 2022
First Posted (Actual)
December 8, 2022
Study Record Updates
Last Update Posted (Actual)
March 15, 2024
Last Update Submitted That Met QC Criteria
March 13, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21-4624
- 1R01CA248658-01A1 (U.S. NIH Grant/Contract)
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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