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

Tobacco Use Disorder Clinical Trial

— EQQUAL  

Official title:

A Scalable E-Health Smoking Cessation Intervention for Sexual and Gender Minority Young Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04194918
• Other study ID #: RG1004771
• Secondary ID: NCI-2019-08031P3
• Status: Completed
• Phase: Phase 1
• Start date: May 18, 2020
• Est. completion date: September 1, 2020

Study information

• Verified date: October 2020
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• Computer-Assisted Smoking Cessation Intervention
Use the Flexiquit+ program

Other:
• Text Message
Receive text messages
• Handout
Receive handouts via email
• Questionnaire Administration
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI), The Safeway Foundation

Country where clinical trial is conducted

United States, 

Outcome

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