Flexiquit+: Web Program to Promote Smoking Cessation in Sexual and Gender Minority Young Adult Smokers

NCT ID: NCT04194918

Last Updated: 2020-10-05

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

PHASE1

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-18

Study Completion Date

2020-09-01

Brief Summary

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This phase I trial studies how well Flexiquit+ helps young adult smokers who identify as a sexual and/or gender minority to quit or cut down on smoking. Flexiquit+ is an avatar-led, web-based intervention that can help smokers quit or cut back on how much they smoke cigarettes and/or vape, reducing their chances of developing tobacco-related health conditions.

Detailed Description

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OUTLINE:

Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.

Participants are followed up with at 2 months.

Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Prevention (Flexiquit+, text message, handout)

Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.

Group Type EXPERIMENTAL

Computer-Assisted Smoking Cessation Intervention

Intervention Type BEHAVIORAL

Use the Flexiquit+ program

Text Message

Intervention Type OTHER

Receive text messages

Handout

Intervention Type OTHER

Receive handouts via email

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Computer-Assisted Smoking Cessation Intervention

Use the Flexiquit+ program

Intervention Type BEHAVIORAL

Text Message

Receive text messages

Intervention Type OTHER

Handout

Receive handouts via email

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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SMS Text SMS Text Message Text Quality of Life Assessment

Eligibility Criteria

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Inclusion Criteria

* 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 and anticipate remaining in the United States for the duration of the study (2 months)
* Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening
* Participants must self-report having at least weekly internet access for the next two months
* Participants must self-report being willing and able to stream 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
* 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 are not currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
* Participants must self-report that they have not participated in one of our prior smoking cessation studies, including the user-centered research conducted in the development of Flexiquit+
* 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 in a prison
* Participants must be willing to use the Flexiquit+ program, complete the study assessments, and sign an online consent form
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

The Safeway 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-2019-08031

Identifier Type: REGISTRY

Identifier Source: secondary_id

P30CA015704

Identifier Type: NIH

Identifier Source: secondary_id

View Link

10396

Identifier Type: OTHER

Identifier Source: secondary_id

RG1004771

Identifier Type: -

Identifier Source: org_study_id

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