Avatar-Led Digital Therapeutic for Aiding Smoking Cessation in Sexual and Gender Minority Young Adults

Avatar-Led Digital Therapeutic to Aid Smoking Cessation Among Sexual and Gender Minority Young Adults

This trial assesses the acceptability and preliminary efficacy of Empowered, Queer, Quitting, and Living (EQQUAL) smoking-cessation intervention for sexual and gender minority young adult smokers. The prevalence of tobacco use among sexual and gender minority (SGM) young adults is more than twice as high as non-SGM young adults, suggesting that existing SGM-related disparities in tobacco use will persist well into the foreseeable future unless sustained efforts are undertaken to address them. EQQUAL is an online smoking cessation intervention designed specifically for SGM young adult smokers, and may help them quit smoking.

Study Overview

• Status: Completed
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Behavioral: Online Smoking Cessation Intervention; Behavioral: Online Smoking Cessation Intervention; Other: Health Promotion and Education

Detailed Description

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive self-guided, online quit smoking program, called EQQUAL Program A.

ARM II: Participants receive self-guided online quit smoking program, EQQUAL Program B.

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• DEMOGRAPHIC CRITERIA:
• Participants must self-identify being between 18 and 30 years of age
• 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, with a United States (US) mailing address, and anticipate remaining in the US for the duration of the study (3 months)
• SMOKING CRITERIA:
• Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening
• TREATMENT ACCESSIBILITY:
• Participants must self-report having at least weekly Internet access for the next three months
• Participants must self-report being willing and able to stream audio and 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
• OTHER CRITERIA:
• 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 have not participated in one of our prior smoking cessation studies
• 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
• Participants must be willing to use the assigned intervention program, complete the study assessments, and consent to participate in this study
• Participants must be willing to upload a photo of themselves (face visible)

Exclusion Criteria:

• Participants must not be currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (but initiating these treatments during the study is allowed)
• Participants must not be a member of the same household as another research participant
• Having a Google voice number as their sole phone number

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (EQQUAL A); Participants receive self-guided online EQQUAL A program on study. Participants also receive motivational messages and smoking cessation information via text messages.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Online Smoking Cessation Intervention; Receive EQQUAL A intervention; Other Names: Smoking and Tobacco Use Cessation Intervention; Behavioral: Online Smoking Cessation Intervention; Receive EQQUAL B intervention; Other Names: Smoking and Tobacco Use Cessation Intervention; Other: Health Promotion and Education; Receive motivational messages and smoking cessation information via SMS text messages
Active Comparator: Arm II (EQQUAL B); Participants receive self-guided online EQQUAL B program on study. Participants also receive motivational messages and smoking cessation information via text messages.	Other: Questionnaire Administration; Ancillary studies; Behavioral: Online Smoking Cessation Intervention; Receive EQQUAL A intervention; Other Names: Smoking and Tobacco Use Cessation Intervention; Behavioral: Online Smoking Cessation Intervention; Receive EQQUAL B intervention; Other Names: Smoking and Tobacco Use Cessation Intervention; Other: Health Promotion and Education; Receive motivational messages and smoking cessation information via SMS text messages

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall satisfaction	Will be assessed with a 5-point Likert-type item on the 3-month survey. Responses will be recorded into a binary variable representing responses of "mostly satisfied" or "very satisfied" versus all other responses (i.e., "not at all," "a little," and "somewhat"). Will test for statistical differences between arms using a logistic regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).	At 3-month follow-up
Average change in Contemplation Ladder scores	Contemplation Ladder scores will be used to assess readiness to quit using cigarettes. Will test for statistical differences between arms using linear regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).	Baseline through 3-month follow-up
Reduction in cigarettes smoked per day	Change in cigarette smoked per day will be assessed as the difference between average number of cigarettes smoked per day over the past 7 days at baseline and at 3-month follow-up. Will test for statistical differences between arms using a negative binomial regression with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).	Baseline through 3-month follow-up
7-day point prevalence abstinence (PPA) from all nicotine and tobacco use	Self-report of no nicotine and tobacco use over the past 7 days, biochemically confirmed via saliva cotinine. Will test for statistical differences between arms using a logistic regression, with adjustment for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome (i.e., potential confounders).	At 3-month follow-up
Usability of the Empowered, Queer, Quitting, and Living (EQQUAL) program	Measured by the System Usability Scale. Will be presented descriptively as an average usability score.	At 3-month follow-up
Acceptability of the EQQUAL avatar	Will be assessed using the Agent Persona Instrument, an adapted version of the Robotics Social Attribute Scale, and 4 open-ended, study specific questions. Will be presented descriptively as frequencies and percentages.	At 3-month follow-up
Number of EQQUAL sessions completed	Will be presented descriptively as frequencies and percentages.	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the acceptance of smoking triggers	Assessed by the emotional and physical subscales of the Avoidance and Inflexibility Scale (AIS). Will calculate the change score as 3-month follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome.	Baseline through 3-month follow-up
Changes in psychological flexibility	Assessed by the short version of the Multidimensional Psychological Flexibility Inventory (MPFI). Will calculate the change score as 3-month follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome.	Baseline through 3-month follow-up
Changes in valued living	Assessed by the Valuing Questionnaire. Will calculate the change score as 3-month follow-up minus baseline score and use a linear regression model with adjustment for the baseline value of the measure of interest and for the stratification variables, as well as adjustment for any baseline variables that had a statistically significant difference by study arm and were associated with the outcome.	Baseline through 3-month follow-up
Differences in 3-month smoking outcomes between those with high versus low baseline readiness to quit	Will be presented descriptively as frequencies and percentages.	Baseline through 3-month follow-up
Differences in 3-month smoking outcomes between those who identify as gender minority versus those who don't	Will be presented descriptively as frequencies and percentages.	Baseline through 3-month follow-up

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: The Leonard and Norma Klorfine Foundation
• Investigators: Principal Investigator: Jaimee Heffner, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): August 20, 2023
• Primary Completion (Actual): June 13, 2024
• Study Completion (Actual): June 13, 2024

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: April 27, 2023
• First Posted (Actual): May 8, 2023

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 17, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: RG1123270 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2023-03050 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No