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

Cigarette Smoking-Related Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05847673
• Other study ID #: RG1123270
• Secondary ID: NCI-2023-03050RG
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 20, 2023
• Est. completion date: July 15, 2024

Study information

• Verified date: March 2024
• Source: Fred Hutchinson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 125
• Est. completion date: July 15, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoking-Related Carcinoma

Intervention

Behavioral:
• Online Smoking Cessation Intervention
Receive EQQUAL A intervention
• Online Smoking Cessation Intervention
Receive EQQUAL B intervention

Other:
• Questionnaire Administration
Ancillary studies
• Health Promotion and Education
Receive motivational messages and smoking cessation information via SMS text messages

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	The Leonard and Norma Klorfine Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Number of EQQUAL sessions completed	Will be presented descriptively as frequencies and percentages.	Up to 3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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