Tobacco Cessation for Sexual Minorities

NCT03643679 | Terminated

• 1 other identifier: PRO18050656
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Helpfulness, frequency of use, and ease of use of the intervention smartphone app

  Assessment of feasibility: Two follow-up surveys will be administered: the first, 1-month after recruitment,and the second, 3 months after recruitment. Surveys will be administered in-person. Specific questions will be asked to rate the Kwit smartphone application's feasibility, based on a combination of helpfulness, frequency of use, and ease of use. Frustrations and helpful aspects of the application will be assesses qualitatively. 1. How helpful was the Kwit app? 2. Was the app easy to use? 3. Was it frustrating to use? Responses for 1-3 will be limited to Very helpful, Somewhat helpful, Neutral, Not very helpful, Not at all helpful 4. What, if anything, was helpful about the app? What, if anything, was not helpful about the app? Each of these responses (Q1-3) will be combined to report a single overall feasibility value. Qualitative data (Q4) will be used to modify scores as needed.

  1-month and 3-month

Secondary Outcomes (2)

• Cessation (self-report)

  1-month and 3-month

• Cessation (bio-chemical)

  1-month and 3-month

Study Arms (1)

Kwit smartphone app

EXPERIMENTAL

This arm will receive the Kwit smartphone app.

Other: Kwit smartphone app

Interventions

Kwit smartphone app 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.

Kwit smartphone app

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Already receiving pharmacological and/or behavioral intervention or counseling for smoking cessation

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Kar-Hai Chu, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 21, 2018
• First Posted: August 23, 2018
• Study Start: October 4, 2018
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: July 7, 2020

Record last verified: 2020-07

Locations

US (1)