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

NCT ID: NCT05847673

Last Updated: 2024-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-20

Study Completion Date

2024-06-13

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cigarette Smoking-Related Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Online Smoking Cessation Intervention

Intervention Type BEHAVIORAL

Receive EQQUAL A intervention

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Health Promotion and Education

Intervention Type OTHER

Receive motivational messages and smoking cessation information via SMS text messages

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.

Group Type ACTIVE_COMPARATOR

Online Smoking Cessation Intervention

Intervention Type BEHAVIORAL

Receive EQQUAL B intervention

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Health Promotion and Education

Intervention Type OTHER

Receive motivational messages and smoking cessation information via SMS text messages

Interventions

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Online Smoking Cessation Intervention

Receive EQQUAL A intervention

Intervention Type BEHAVIORAL

Online Smoking Cessation Intervention

Receive EQQUAL B intervention

Intervention Type BEHAVIORAL

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Health Promotion and Education

Receive motivational messages and smoking cessation information via SMS text messages

Intervention Type OTHER

Other Intervention Names

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Smoking and Tobacco Use Cessation Intervention Smoking and Tobacco Use Cessation Intervention

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Leonard and Norma Klorfine Foundation

UNKNOWN

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jaimee Heffner

Role: PRINCIPAL_INVESTIGATOR

Fred Hutch/University of Washington Cancer Consortium

Locations

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Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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NCI-2023-03050

Identifier Type: REGISTRY

Identifier Source: secondary_id

RG1123270

Identifier Type: OTHER

Identifier Source: secondary_id

RG1123270

Identifier Type: -

Identifier Source: org_study_id

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