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Effect of Helpers Program On-line Training on Smoking Relapse and Social Networks

Primary Purpose

Smoking, Cigarette Smoking

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Helpers Stay Quit Training
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking focused on measuring Smoking cessation, Relapse prevention

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 18 years or older Abstinent from smoking for between 14 and 45 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

Sites / Locations

  • University of Colorado Anschutz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Helpers Stay Quit Training

Usual Care

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

7-day and 30-day abstinence from using combustible tobacco at 6 months post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
7-day and 30-day abstinence from using combustible tobacco at 12 months post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.

Secondary Outcome Measures

7-day and 30-day abstinence from using combustible tobacco at 3 months and 9 months post-randomization
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Time to first relapse
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Number, timing, and duration of relapses
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Number of helping conversations offered
Participants report the number of helping conversations (if any) offered within the specified timeframe.
Biochemical confirmation of abstinence at 6 and 12 months on a subsample
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.

Full Information

First Posted
November 21, 2022
Last Updated
January 19, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05641974
Brief Title
Effect of Helpers Program On-line Training on Smoking Relapse and Social Networks
Official Title
Effect of Helpers Program On-line Training on Smoking Relapse and Social Networks
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 12, 2022 (Actual)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Cigarette Smoking
Keywords
Smoking cessation, Relapse prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
940 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Helpers Stay Quit Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Helpers Stay Quit Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
7-day and 30-day abstinence from using combustible tobacco at 6 months post-randomization
Description
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Time Frame
Self-reported data collected at 6 months post-randomization
Title
7-day and 30-day abstinence from using combustible tobacco at 12 months post-randomization
Description
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Time Frame
Self-reported data collected at 12 months post-randomization
Secondary Outcome Measure Information:
Title
7-day and 30-day abstinence from using combustible tobacco at 3 months and 9 months post-randomization
Description
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Time Frame
Self-reported data collected at 3- and 9-months post-randomization
Title
Time to first relapse
Description
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Time Frame
Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization
Title
Number, timing, and duration of relapses
Description
Participants report the number of days (if any) they smoked combustible tobacco within the specified timeframe.
Time Frame
Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization
Title
Number of helping conversations offered
Description
Participants report the number of helping conversations (if any) offered within the specified timeframe.
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
Title
Biochemical confirmation of abstinence at 6 and 12 months on a subsample
Description
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.
Time Frame
Data collected and 6- and 12-months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18 years or older Abstinent from smoking for between 14 and 45 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myra Muramoto, MD, MPH
Organizational Affiliation
University of Colorado School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Anschutz
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32966558
Citation
Muramoto ML, Hopkins A, Bell M, Allen A, Nair U, Connolly TE. Results of a Feasibility Study of Helpers Stay Quit Training for Smoking Relapse Prevention. Nicotine Tob Res. 2021 Mar 19;23(4):711-715. doi: 10.1093/ntr/ntaa176.
Results Reference
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Learn more about this trial

Effect of Helpers Program On-line Training on Smoking Relapse and Social Networks

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