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OpenTrials
Completed

NCT Number: NCT04194918

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

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.

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Key information

Conditions

Tobacco Use Disorder Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computer-Assisted Smoking Cessation Intervention

Behavioral

Use the Flexiquit+ program

Text message

Other

Receive text messages

Other names: SMS Text, SMS Text Message, Text

Handout

Other

Receive handouts via email

Questionnaire Administration

Other

Ancillary studies

Quality-of-Life Assessment

Other

Ancillary studies

Other names: Quality of Life Assessment

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. 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.

  2. Change in motivation to quit smoking

    Time frame: From baseline to 2-month follow-up

    Will be assessed using the Contemplation Ladder.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)
  • The Safeway Foundation

Registry information

Official study title

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

Acronym: EQQUAL

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 11, 2019
Registry last updated
Oct 5, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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