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

July 17, 2024 updated by: Fred Hutchinson Cancer Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
125

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall satisfaction
Time Frame: At 3-month follow-up
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
Time Frame: Baseline through 3-month follow-up
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
Time Frame: Baseline through 3-month follow-up
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
Time Frame: At 3-month follow-up
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
Time Frame: At 3-month follow-up
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
Time Frame: At 3-month follow-up
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
Time Frame: Up to 3 months
Will be presented descriptively as frequencies and percentages.
Up to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in the acceptance of smoking triggers
Time Frame: Baseline through 3-month follow-up
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
Time Frame: Baseline through 3-month follow-up
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
Time Frame: Baseline through 3-month follow-up
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
Time Frame: Baseline through 3-month follow-up
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
Time Frame: Baseline through 3-month follow-up
Will be presented descriptively as frequencies and percentages.
Baseline through 3-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fred Hutchinson Cancer Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Leonard and Norma Klorfine Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jaimee Heffner, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 20, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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