Flexiquit+: Web Program to Promote Smoking Cessation in Sexual and Gender Minority Young Adult Smokers

Phase 1

Completed

• Conditions: Tobacco Use Disorder
• Interventions: Behavioral: Computer-Assisted Smoking Cessation Intervention; Other: Text Message; Other: Handout; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration

• Registration Number: NCT04194918
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief Summary

This phase I trial studies how well Flexiquit+ helps young adult smokers who identify as a sexual and/or gender minority to quit or cut down on smoking. Flexiquit+ is an avatar-led, web-based intervention that can help smokers quit or cut back on how much they smoke cigarettes and/or vape, reducing their chances of developing tobacco-related health conditions.

Detailed Description

OUTLINE:

Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.

Participants are followed up with at 2 months.

Study Timeline

• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-10
• Study First Posted: 2019-12-11
• Study Start: 2020-05-18
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-02
• Last Update Posted: 2020-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Participants must self-identify as a sexual and/or gender minority (i.e., a sexual orientation other than straight and/or gender that doesn't match sex assigned at birth)
• Participants must currently reside in the United States and anticipate remaining in the United States for the duration of the study (2 months)
• Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening
• Participants must self-report having at least weekly internet access for the next two months
• Participants must self-report being willing and able to stream video online for this study
• Participants must self-report current use of a personal email account
• Participants must self-report current use of text messaging
• Participants must self-report that they are interested in participating in the study for themselves (versus [vs] someone else)
• Participants must self-report that they are not currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
• Participants must self-report that they have not participated in one of our prior smoking cessation studies, including the user-centered research conducted in the development of Flexiquit+
• Participants must self-report that they are comfortable reading, writing, and speaking English
• Participants must self-report that they understand and agree to the conditions of compensation
• Participants must self-report that they are not currently incarcerated in a prison
• Participants must be willing to use the Flexiquit+ program, complete the study assessments, and sign an online consent form

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevention (Flexiquit+, text message, handout)	Questionnaire Administration	Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.
Prevention (Flexiquit+, text message, handout)	Quality-of-Life Assessment	Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.
Prevention (Flexiquit+, text message, handout)	Computer-Assisted Smoking Cessation Intervention	Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.
Prevention (Flexiquit+, text message, handout)	Text Message	Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.
Prevention (Flexiquit+, text message, handout)	Handout	Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.
Prevention (Flexiquit+, text message, handout)	Survey Administration	Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.

Primary Outcome Measures

Name	Time	Method
Treatment utilization	Enrollment up to 2 months	Will be determined by the server-recorded number of logins and the number of sessions completed. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Tables with N (%) or mean (standard deviation) by treatment arm will be provided.
Treatment satisfaction: survey	Enrollment up to 2 months	Will be determined using 12 items on the 2-month outcome survey. Frequencies (for categorical variables) or means and standard deviations (for continuous variables) will be reported for treatment utilization and satisfaction. Categorical ratings for treatment satisfaction questions will be dichotomized as "somewhat", "mostly", or "very" useful versus (vs.) lower ratings. Tables with N (%) or mean (standard deviation) by treatment arm will be provided.

Secondary Outcome Measures

Name	Time	Method
Smoking cessation rate	At 2 months post-enrollment	Will be assessed using the self-reported 7-day point prevalence abstinence at 2-month follow-up survey, biochemically confirmed with saliva cotinine.
Change in motivation to quit smoking	From baseline to 2-month follow-up	Will be assessed using the Contemplation Ladder.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States