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

NCT05847673 | Completed DMC

• 2 other identifiers: RG1123270NCI-2023-03050
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• Changes in the acceptance of smoking triggers

  Baseline through 3-month follow-up

• Changes in psychological flexibility

  Baseline through 3-month follow-up

• Changes in valued living

  Baseline through 3-month follow-up

• Differences in 3-month smoking outcomes between those with high versus low baseline readiness to quit

  Baseline through 3-month follow-up

• Differences in 3-month smoking outcomes between those who identify as gender minority versus those who don't

  Baseline through 3-month follow-up

Study Arms (2)

Arm I (EQQUAL A)

EXPERIMENTAL

Participants receive self-guided online EQQUAL A program on study. Participants also receive motivational messages and smoking cessation information via text messages.

Behavioral: Online Smoking Cessation Intervention; Other: Questionnaire Administration; Other: Health Promotion and Education

Arm II (EQQUAL B)

ACTIVE COMPARATOR

Participants receive self-guided online EQQUAL B program on study. Participants also receive motivational messages and smoking cessation information via text messages.

Behavioral: Online Smoking Cessation Intervention; Other: Questionnaire Administration; Other: Health Promotion and Education

Interventions

Online Smoking Cessation Intervention BEHAVIORAL

Receive EQQUAL A intervention

Also known as: Smoking and Tobacco Use Cessation Intervention

Arm I (EQQUAL A)

Questionnaire Administration OTHER

Ancillary studies

Arm I (EQQUAL A); Arm II (EQQUAL B)

Health Promotion and Education OTHER

Receive motivational messages and smoking cessation information via SMS text messages

Arm I (EQQUAL A); Arm II (EQQUAL B)

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• The Leonard and Norma Klorfine Foundation: collaborator

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Interventions

Smoking Devices; Health Promotion; Educational Status

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Socioeconomic Factors; Population Characteristics

Study Officials

• Jaimee Heffner

  Fred Hutch/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 8, 2023
• Study Start: August 20, 2023
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: July 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)