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

NCT05641974 | Active Not Recruiting DMC

• 2 other identifiers: 21-46241R01CA248658-01A1
• Study Type: interventional
• Target: 940
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking; Cigarette Smoking

Keywords

Smoking cessation; Relapse prevention

Outcome Measures

Primary Outcomes (2)

• 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.

  Self-reported data collected at 6 months post-randomization

• 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.

  Self-reported data collected at 12 months post-randomization

Secondary Outcomes (5)

• 7-day and 30-day abstinence from using combustible tobacco at 3 months and 9 months post-randomization

  Self-reported data collected at 3- and 9-months post-randomization

• Time to first relapse

  Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization

• Number, timing, and duration of relapses

  Weekly data collected months 1-6, bi-weekly data collected months 7-12 post-randomization

• Number of helping conversations offered

  Weekly data collected months 1-6; bi-weekly data collected months 7-12; data collected at 3-, 6-, 9-, and 12-months post-randomization

• Biochemical confirmation of abstinence at 6 and 12 months on a subsample

  Data collected and 6- and 12-months post-randomization

Study Arms (2)

Helpers Stay Quit Training

EXPERIMENTAL

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.

Behavioral: Helpers Stay Quit Training

Usual Care

NO INTERVENTION

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).

Interventions

Helpers Stay Quit Training BEHAVIORAL

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.

Helpers Stay Quit Training

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any prior exposure to Helpers training or other cessation training in the previous 2 years

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Colorado Anschutz

Aurora, Colorado, 80045, United States

Location

Related Publications (1)

• 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.

  PMID: 32966558 BACKGROUND

MeSH Terms

Conditions

Smoking; Cigarette Smoking; Smoking Cessation

Condition Hierarchy (Ancestors)

Behavior; Tobacco Smoking; Tobacco Use; Health Behavior

Study Officials

• Myra Muramoto, MD, MPH

  University of Colorado School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician analyzing outcomes is blinded to study arm assignment
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 8, 2022
• Study Start: December 12, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): February 27, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-02

Locations

US (1)