Mobile-based Peer Mentoring for Smoking Cessation

Study Overview
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Brief Summary
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Despite the availability of a variety of effective treatments for smoking cessation, uptake of treatments is low. The increasing use of smartphone technology presents an exceptional opportunity to expand access to low-cost smoking cessation services. In this pilot study, the investigators will use a text-messaging platform to test peer mentoring for smoking cessation, delivered by former smokers. While peer mentoring is a common approach to health behavior change, it has rarely been used to maximum effect by smoking cessation programs. The text-messaging platform serves as the basis for a randomized controlled trial to test the effectiveness of peer mentoring for smoking cessation. This pilot will include approximately 200 U.S. adult smokers who will be randomly assigned to a peer mentor or not. Participants in the control group will receive automated text messages used in SmokefreeTXT, a nationwide text-messaging service sponsored by the National Cancer Institute (NCI) in which users receive one to five automated messages per day for up to eight weeks. Smokers in the intervention group will receive a modified version of the same automated messages from SmokefreeTXT, but with additional personalized messages from an assigned peer mentor. Mentors will provide responses to specific questions or comments a smoker may have after receiving the automated messages. The intervention will last 8 weeks. The study includes primary outcomes to measure the acceptability, engagement, user experience, and early efficacy of the intervention.

Official Title
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Mobile-based Peer Mentoring for Smoking Cessation: A Pilot Study

Conditions
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Smoking Cessation, Tobacco Use

Intervention / Treatment
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* Behavioral: Control
* Behavioral: Peer Mentoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 18 years old Current resident of the U.S. Smoked 100 or more cigarettes in lifetime Current cigarette smoker Access to a device that can take pictures to be uploaded to a website Willing to complete a salivary cotinine test Exclusion Criteria: Not a current user of nicotine replacement therapy Not a current user of electronic cigarettes

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm<br>Participants will receive automated text messages drawn from the script used by SmokefreeTXT. | Behavioral: Control<br>* Participants will receive automated text messages used by SmokefreeTXT. The messages are designed to provide encouragement, support, and information about quitting smoking. Participants will receive 1-5 automated messages per day for 6-8 weeks depending on choice of quit date.<br>|
| Experimental: Peer Mentoring Arm<br>Participants will receive a modified version of the automated text messages sent to the control arm plus random assignment to a peer mentor. | Behavioral: Peer Mentoring<br>* Participants will receive a modified version of the automated text messages sent to the control arm plus random assignment to a peer mentor. The modified messages include automated conversation starters, designed to stimulate conversation with the peer mentor. The peer mentor will then send personalized, tailored responses. The peer mentor is a former smoker who has completed a training program developed by the investigator team. Participants will receive 1-5 automated messages per day for 6-8 weeks depending on choice of quit date.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Saliva test for cotinine | The primary measure of early efficacy is the 7-day point prevalence of abstinence measured 3 months after the quit day, using a saliva cotinine test. The saliva test results will be recorded through a series of photographs and shared with the study team via email or online upload. Participants who self-report having smoked in the last 7 days, as part of the follow-up survey, will be considered to be continuing smokers. | 3 months after quit day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported smoking status | Participants will self-report 7-day point prevalence of abstinence in the follow-up survey, measured 3 months after the quit day. | 3 months after quit day | 
| Duration of engagement | The primary measure of participant engagement is the number of days from enrollment since the participant last replied to a message asking about the person's status (e.g., mood and cravings). The status messages are common to the scripts sent to participants in the control and peer mentoring arms. | Up to 8 weeks | 
| Satisfaction with the program | The primary measure of acceptability of the intervention is the self-reported rating of participants to the statement, I liked participating in the iQuit Project. Responses will be on a 5-point Likert scale from completely disagree to completely agree. | 3 months after quit day | 
| Proportion of participants who correctly self-report their message type | The primary measure of user experience in the intervention is whether participants correctly identify the type of messages they received: automated or personal from a mentor. The measure has four categories: assigned to automated messages and self-reports receiving automated messages only, assigned to automated messages and self-reports receiving at least some messages from a mentor, assigned to mentor messages and self-reports receiving at least some mentor messages, and assigned to mentor messages and self-reports receiving automated messages only. | 3 months after quit day | 
| Change in average cigarettes per day | This measures the difference in self-reported average number of cigarettes smoked per day from the baseline survey to the follow-up survey 3 months after quit day | 3 months after quit day | 
| Number of participant messages sent | This measure of engagement is the number of resp days from enrollment since the participant last replied to a message asking about the person's status (e.g., mood and cravings). The status messages are common to the scripts sent to participants in the control and peer mentoring arms. | Throughout the 6-8 week intervention | 
| Proportion who unsubscribe | This measure of engagement is the proportion of participants who unsubscribe from the text-messaging intervention prior to the end of the intervention period. | Throughout the 6-8 week intervention | 
| Accuracy of beliefs about personal content | This is the difference between the percentage of messages reported to be from a mentor (as opposed to being automated) and the actual percentage. | Throughout the 6-8 week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peer mentoring, social support, text messaging, smoking cessation