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

Overview

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.

Full Title of Study: “A Scalable E-Health Smoking Cessation Intervention for Sexual and Gender Minority Young Adults”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 18, 2020

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.

Interventions

  • Behavioral: Computer-Assisted Smoking Cessation Intervention
    • Use the Flexiquit+ program
  • Other: Text Message
    • Receive text messages
  • Other: Handout
    • Receive handouts via email
  • Other: Questionnaire Administration
    • Ancillary studies
  • Other: Quality-of-Life Assessment
    • Ancillary studies
  • Other: Survey Administration
    • Ancillary studies

Arms, Groups and Cohorts

  • Experimental: Prevention (Flexiquit+, text message, 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.

Clinical Trial Outcome Measures

Primary Measures

  • Treatment utilization
    • Time Frame: 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
    • Time Frame: 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 Measures

  • Smoking cessation rate
    • Time Frame: 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
    • Time Frame: From baseline to 2-month follow-up
    • Will be assessed using the Contemplation Ladder.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 30 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fred Hutchinson Cancer Research Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jaimee Heffner, Principal Investigator, Fred Hutch/University of Washington Cancer Consortium

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