Mobile-based Peer Mentoring for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03048786
• Other study ID #: 16-18577
• Status: Completed
• Phase: N/A
• Start date: February 6, 2017
• Est. completion date: August 14, 2017

Study information

• Verified date: August 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 14, 2017
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation
• Tobacco Use

Intervention

Behavioral:
• Control
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.
• Peer Mentoring
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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, San Francisco	American Cancer Society, Inc., George Washington University, London School of Economics and Political Science

Country where clinical trial is conducted

United States, 

References & Publications (1)

White JS, Toussaert S, Thrul J, Bontemps-Jones J, Abroms L, Westmaas JL. Peer Mentoring and Automated Text Messages for Smoking Cessation: A Randomized Pilot Trial. Nicotine Tob Res. 2020 Mar 16;22(3):371-380. doi: 10.1093/ntr/ntz047. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Self-reported smoking status during the intervention	This is self-reported 7-day point prevalence based on text message replies to a status message. The status messages were sent at days 7, 14, 21, 28, 35, 42, 60, and 90, relative to the person's quit date.	From quit day to day 90
Other	Recommends the program	This is a 5-point Likert scale response to "I would recommend the iQuit Project to a friend," assessed in the follow-up survey.	3 months after quit day
Other	Helpfulness of information	This is a 5-point Likert scale response to "Text messages contained helpful information on quitting," assessed in the follow-up survey.	3 months after quit day
Other	Helpfulness in trying to quit	This is a 5-point Likert scale response to "Text messages helped me try to quit smoking," assessed in the follow-up survey.	3 months after quit day
Other	Timeliness of messages	This is a 5-point Likert scale response to "Text messages arrived at the right time," assessed in the follow-up survey.	3 months after quit day
Other	Personalized content of messages	This is a 5-point Likert scale response to "Text messages were created for me personally," assessed in the follow-up survey.	3 months after quit day
Other	Frequency of messages too low	This is a 5-point Likert scale response to "Text messages should have been sent more frequently," assessed in the follow-up survey.	3 months after quit day
Other	Frequency of messages too high	This is a 5-point Likert scale response to "Text messages should have been sent less frequently," assessed in the follow-up survey.	3 months after quit day
Other	Tailoring of messages	This is a 5-point Likert scale response to "Text messages applied to me specifically," assessed in the follow-up survey.	3 months after quit day
Other	Messages were caring	This is a 5-point Likert scale response to "Text messages made me feel someone cared if I quit," assessed in the follow-up survey.	3 months after quit day
Other	Messages gave feeling of worth	This is a 5-point Likert scale response to "Text messages made me think that it was worthwhile for me to quit," assessed in the follow-up survey.	3 months after quit day
Other	Messages gave feeling of competence	This is a 5-point Likert scale response to "Text messages made me feel that I knew the right steps to take to quit," assessed in the follow-up survey.	3 months after quit day
Other	Messages gave feeling of confidence	This is a 5-point Likert scale response to "Text messages gave me confidence that I can quit," assessed in the follow-up survey.	3 months after quit day
Other	Days to unsubscribe	This is the number of days since enrollment that it took the participant to unsubscribe.	Throughout the 6-8 week intervention
Other	Proportion of replies that provide informational vs. emotional support	This is the proportion of a participant's replies that are in response to a message coded with information support, as opposed to emotional support.	Throughout the 6-8 week intervention
Other	Percentage of personalized messages	This is the percentage of messages that the participant believes came from a mentor, as opposed to the automated script.	3 months after enrollment
Other	Preference for personalized messages	This is the percentage of participants who prefer personal messages from mentors, compared to automated messages.	3 months after enrollment
Other	Integration of messages	This is a 5-point Likert scale response to "The automated and personal messages worked well together," assessed in the follow-up survey.	3 months after enrollment
Other	Satisfaction with mentor	This is a 5-point Likert scale response to "I am satisfied with my mentor," assessed in the follow-up survey.	3 months after enrollment
Other	Knowledge of mentor	This is a 5-point Likert scale response to "I think my mentor was knowledgable," assessed in the follow-up survey.	3 months after enrollment
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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