Tobacco Cessation for Sexual Minorities

NCT ID: NCT03643679

Last Updated: 2020-07-07

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

TERMINATED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-04

Study Completion Date

2020-06-30

Brief Summary

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There is a growing body of evidence revealing disproportionately higher rates of tobacco use among sexual and gender minority (SGM) individuals, compared to their heterosexual peers. These disparities have led organizations to support the inclusion of SGM in all local, state, and national tobacco prevention and control activities. In an attempt to leverage the online milieu for health-related interventions, mobile apps have been created to support tobacco cessation. However, evidence-based apps promoted by the National Cancer Institute are unpopular, remain poorly supported, and were not studied for use by SGM persons. Commercial apps, on the other hand, have been downloaded millions of times, contain many valuable features, and enjoy better infrastructure. Unfortunately, they are not evidence-based and have not been rigorously tested.

The University of Pittsburgh (Pitt) is currently conducting a randomized controlled trial to assess the feasibility and efficacy of using the Kwit tobacco cessation app with patients at UPMC Montefiore and Presbyterian hospitals (PI: Chu). It is a pragmatic clinical trial applying a patient-centered outcomes framework to ensure that-rather than focusing only on successful cessation-the study includes measurements for quality of life, mobility, and social interactions. We propose to extend the study to underrepresented SGM young adults.

Survey measures will be adapted as needed to address issues specific to the SGM population.

Detailed Description

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Conditions

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Smoking Cessation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Kwit smartphone app

This arm will receive the Kwit smartphone app.

Group Type EXPERIMENTAL

Kwit smartphone app

Intervention Type OTHER

The Kwit smartphone app combines several popular features of tobacco cessation apps, including game-like features (e.g., unlocking achievement milestones for completing cessation-related tasks), useful statistics (e.g., money saved), and an ability to share progress with friends. Users can actively engage with the app to track cravings or view progress, such as life expectancy gained. A passive component notifies users when milestones have been achieved, e.g., when blood no longer contains nicotine. Motivational messages can be actively requested at any time; they can also appear unsolicited, as when the user logs cravings.

Interventions

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Kwit smartphone app

The Kwit smartphone app combines several popular features of tobacco cessation apps, including game-like features (e.g., unlocking achievement milestones for completing cessation-related tasks), useful statistics (e.g., money saved), and an ability to share progress with friends. Users can actively engage with the app to track cravings or view progress, such as life expectancy gained. A passive component notifies users when milestones have been achieved, e.g., when blood no longer contains nicotine. Motivational messages can be actively requested at any time; they can also appear unsolicited, as when the user logs cravings.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18-30
* Self-identified as a sexual minority (gay, lesbian, bisexual)
* Smokers interested in cessation (\>1 cigarettes/day over the past 30 days)
* Must own an Apple or Android based smartphone.

Exclusion Criteria

* Already receiving pharmacological and/or behavioral intervention or counseling for smoking cessation
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Kar-Hai Chu

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kar-Hai Chu, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PRO18050656

Identifier Type: -

Identifier Source: org_study_id

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