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Tobacco Cessation for Sexual Minorities

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03643679
Recruitment Status : Recruiting
First Posted : August 23, 2018
Last Update Posted : October 14, 2019
Sponsor:
Information provided by (Responsible Party):
Kar-Hai Chu, University of Pittsburgh

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.


Condition or disease Intervention/treatment Phase
Smoking Cessation Other: Kwit smartphone app Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Tobacco Cessation for Sexual Minorities
Actual Study Start Date : October 4, 2018
Estimated Primary Completion Date : July 1, 2020
Estimated Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Kwit smartphone app
This arm will receive the Kwit smartphone app.
Other: 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.




Primary Outcome Measures :
  1. Helpfulness, frequency of use, and ease of use of the intervention smartphone app [ Time Frame: 1-month and 3-month ]

    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.



Secondary Outcome Measures :
  1. Cessation (self-report) [ Time Frame: 1-month and 3-month ]

    Descriptive statistics will be used to assess cessation outcomes. The information will be obtained via two follow-up surveys (1 month and 3 months after recruitment), with specific questions pertaining to the level of participant smoking as well as their confidence levels on maintaining cessation.

    1. Since you joined the study, have you smoked a cigarette (even a puff)?
    2. How soon after you joined the study did you smoke your first cigarette, even a puff?
    3. In the past 30 days, on how many days did you smoke (even a puff)?
    4. (On the days you smoked) how many cigarettes on average did you smoke (even a puff)?
    5. In the past 7 days, have you smoked a cigarette, even a puff?
    6. How confident are you that you will be able to stay quit?

    The overall assessment of cessation will be primarily based on the 7-day item.


  2. Cessation (bio-chemical) [ Time Frame: 1-month and 3-month ]
    Cessation will also be verified by a breath analysis monitor. The information will be obtained during each follow-up. Biochemical verification will be based on a 10 COppm cutoff to determine whether or not the participant has successfully quit tobacco.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03643679


Contacts
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Contact: Kar-Hai Chu, PhD 4126924853 chuk@pitt.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Kar-Hai Chu, PhD         
Sub-Investigator: Cesar Escobar-Viera, MD, PhD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Kar-Hai Chu, PhD University of Pittsburgh

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Responsible Party: Kar-Hai Chu, Assistant Professor of Medicine, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03643679    
Other Study ID Numbers: PRO18050656
First Posted: August 23, 2018    Key Record Dates
Last Update Posted: October 14, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No