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

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Computer-Assisted Smoking Cessation Intervention
Text Message
Handout
Questionnaire Administration
Quality-of-Life Assessment
Survey Administration
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Use Disorder

Eligibility Criteria

18 Years - 30 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Prevention (Flexiquit+, text message, handout)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Change in motivation to quit smoking
Will be assessed using the Contemplation Ladder.

Full Information

First Posted
December 9, 2019
Last Updated
October 2, 2020
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI), The Safeway Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04194918
Brief Title
Flexiquit+: Web Program to Promote Smoking Cessation in Sexual and Gender Minority Young Adult Smokers
Acronym
EQQUAL
Official Title
A Scalable E-Health Smoking Cessation Intervention for Sexual and Gender Minority Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
May 18, 2020 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI), The Safeway Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prevention (Flexiquit+, text message, handout)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Computer-Assisted Smoking Cessation Intervention
Intervention Description
Use the Flexiquit+ program
Intervention Type
Other
Intervention Name(s)
Text Message
Other Intervention Name(s)
SMS Text, SMS Text Message, Text
Intervention Description
Receive text messages
Intervention Type
Other
Intervention Name(s)
Handout
Intervention Description
Receive handouts via email
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Treatment utilization
Description
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.
Time Frame
Enrollment up to 2 months
Title
Treatment satisfaction: survey
Description
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.
Time Frame
Enrollment up to 2 months
Secondary Outcome Measure Information:
Title
Smoking cessation rate
Description
Will be assessed using the self-reported 7-day point prevalence abstinence at 2-month follow-up survey, biochemically confirmed with saliva cotinine.
Time Frame
At 2 months post-enrollment
Title
Change in motivation to quit smoking
Description
Will be assessed using the Contemplation Ladder.
Time Frame
From baseline to 2-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaimee Heffner
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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