Clinical trial NCT04194918: Flexiquit+: Web Program to Promote Smoking Cessation in Sexual and Gender Minority Young Adult Smokers
Official title: A Scalable E-Health Smoking Cessation Intervention for Sexual and Gender Minority Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tobacco Use Disorder
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: The Safeway Foundation
First posted: 2019-12-11
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Treatment utilization
timeFrame: Enrollment up to 2 months
measure: Treatment satisfaction: survey
timeFrame: Enrollment up to 2 months
Secondary outcomes:
measure: Smoking cessation rate
timeFrame: At 2 months post-enrollment
measure: Change in motivation to quit smoking
timeFrame: From baseline to 2-month follow-up
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Jaimee Heffner
role: PRINCIPAL_INVESTIGATOR
References: