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

NCT04194918 | Completed Phase 1

• 4 other identifiers: RG1004771NCI-2019-08031P30CA01570410396
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (2)

• Treatment utilization

  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.

  Enrollment up to 2 months

• Treatment satisfaction: survey

  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.

  Enrollment up to 2 months

Secondary Outcomes (2)

• Smoking cessation rate

  At 2 months post-enrollment

• Change in motivation to quit smoking

  From baseline to 2-month follow-up

Study Arms (1)

Prevention (Flexiquit+, text message, handout)

EXPERIMENTAL

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.

Behavioral: Computer-Assisted Smoking Cessation Intervention; Other: Text Message; Other: Handout; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Other: Survey Administration

Interventions

Computer-Assisted Smoking Cessation Intervention BEHAVIORAL

Use the Flexiquit+ program

Prevention (Flexiquit+, text message, handout)

Text Message OTHER

Receive text messages

Also known as: SMS Text, SMS Text Message, Text

Prevention (Flexiquit+, text message, handout)

Handout OTHER

Receive handouts via email

Prevention (Flexiquit+, text message, handout)

Questionnaire Administration OTHER

Ancillary studies

Prevention (Flexiquit+, text message, handout)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Prevention (Flexiquit+, text message, handout)

Survey Administration OTHER

Ancillary studies

Prevention (Flexiquit+, text message, handout)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• The Safeway Foundation: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Communication Devices for People with Disabilities

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Self-Help Devices; Equipment and Supplies

Study Officials

• Jaimee Heffner

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 11, 2019
• Study Start: May 18, 2020
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: October 5, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)