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Empowering LGBTQ+ Tobacco Cessation Pilot

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: NCT05365633
Recruitment Status : Not yet recruiting
First Posted : May 9, 2022
Last Update Posted : May 9, 2022
Sponsor:
Information provided by (Responsible Party):
University of Oklahoma

Brief Summary:
Sexual and/or gender minority (SGM) people have disproportionately high rates of tobacco use - the number one cause of preventable death. Reasons for this include using tobacco to cope with social minority stressors, pro-tobacco use norms in SGM social spaces and networks, and targeted tobacco industry marketing. Empowerment Theory explains how positive behavior change, like quitting smoking, can be promoted through skills development with greater participation in the public affairs of one's community. An empowerment approach may enhance tobacco cessation treatment for SGM people and other stigmatized groups because it links individual well-being with the larger social and political context. This pilot study will assess the acceptability, feasibility, and preliminary impact of empowerment-enhanced tobacco smoking cessation assistance for SGM adults. We will enroll N=20 SGM adults in Oklahoma who smoke and are willing to quit. Participants will receive standard tobacco cessation assistance through the Stephenson Cancer Center Tobacco Treatment Research Program (TTRP). Concurrently, they will also engage in 'empowerment activities', meaning SGM organizing and community-building activities, like SGM-related legislative phone banking. This will be guided by an Oklahoman SGM-serving community partner. Participants will complete 8 surveys during the intervention period and 12 weeks post-quit-date, a 60-minute, in-depth exit interview, and biochemically-verified smoking status before the intervention and 12 weeks post-quit-date. This pilot study will establish collaborative relationships between the PI's team and local SGM-serving organizations, and will produce preliminary findings to support future R01-level funding to conduct a fully-powered randomized control trial of a multi-level empowerment-enhanced SGM tobacco cessation intervention.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Empowerment activity-enhanced tobacco cessation assistance Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single-arm pilot design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Empowering Sexual and/or Gender Minority Tobacco Cessation: A Pilot Study
Estimated Study Start Date : June 1, 2022
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Quitting Smoking

Arm Intervention/treatment
Empowerment activity-enhanced tobacco cessation assistance
Single arm pilot intervention design to assess feasibility and acceptability
Behavioral: Empowerment activity-enhanced tobacco cessation assistance
Participants will receive standard Tobacco Treatment Research Program (TTRP) tobacco cessation assistance either remotely or in-person: 6 weekly counseling sessions and 12 weeks of combination NRT (nicotine patches + nicotine gum or lozenges). During the 6 weeks of counseling, participants will also engage in at least 4 'empowerment activities' (i.e., SGM social change mobilization and community-building activities48) for a total of at least 8 hours. Activities will be tailored to each participant's comfort level and provide COVID-19 risk-reduction options (e.g., remote or masked outdoor activities). Examples are: (i) running tobacco-free Pride events that occur in Jun and Oct in OK; (ii) organizing a virtual SGM town hall to inform the OK State Plan on Aging; (iii) SGM-relevant legislative phone banking (e.g., regarding transgender student participation in school athletics); and (iv) follow-up surveying of Freedom OK's name and gender marker change clinic72 participants.




Primary Outcome Measures :
  1. retention [ Time Frame: 12-weeks post-quit ]
    We will evaluate retention by calculating the proportion of participants who complete the final study visit at 12-weeks post-quit, with the goal of retaining >80% of participants.

  2. participant perceptions of the intervention [ Time Frame: 12 weeks post-quit-date ]
    We will qualitatively assess perceptions of the intervention by interviewing participants over Zoom video chat at during a semi-structured, in-depth exit interview lasting approximately 60 minutes. Interview guide domains will include: (i) best intervention aspects (e.g. highlights, peak experiences); (ii) biggest challenges or negative experiences; (iii) empowerment activity experiences; (iv) interactions of empowerment activity participation with tobacco cessation experiences; (v) outcomes and personal growth (vi) suggestions for intervention improvements.

  3. community partner perceptions of the intervention [ Time Frame: within 1 month of data collection completion ]
    We will qualitatively assess community partner perceptions of the intervention by interviewing Freedom Oklahoma staff over Zoom video chat. Semi-structured, in-depth interview lasting approximately 60 minutes will discuss Freedom Oklahoma staff's perceptions of the intervention and their organization's role in it.

  4. change in adaptive coping strategies [ Time Frame: baseline and 12 weeks post-quit-date ]
    We will compare within subject adaptive coping strategies with baseline and exit surveys (12 weeks post-quit-date) using the Cognitive Emotion Regulation Questionnaire79. We will use a two-sided paired samples t-test to examine the mean differences in adaptive coping strategies pre- and post-intervention (α=0.05). Assuming a standard deviation of differences of 4.085, n=20 participants will provide 80% power to detect a mean difference of 2.6 in adaptive coping strategies.

  5. biochemical verification of tobacco abstinence [ Time Frame: 12 weeks post-quit-date ]
    We will use benchmarks to assess participants' tobacco cessation outcomes. Biochemically-verified smoking status will be measured via expired carbon monoxide at 12 weeks post-quit-date. Tobacco cessation outcomes will be considered successful if the proportion of participants with biochemically-verified smoking abstinence (expired carbon monoxide) at 12 weeks post-quite-date is equal to or greater than the general Tobacco Treatment Research Program (TTRP) sample (i.e., 18% at 12 weeks1).

  6. medication treatment adherence [ Time Frame: 12 weeks post-quit-date ]
    Treatment adherence will be assessed with the 4-item Medication Adherence Questionnaire (MAQ)84 and counseling session attendance tracking.

  7. counseling attendance [ Time Frame: 12 weeks post-quit-date ]
    Counseling attendance will be assessed by tracking the proportion of counseling sessions attended by each participant by 12 weeks post-quit-date.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Self-identify as sexual and/or gender minority
  • Reside in the State of Oklahoma
  • Report past 30 day use of combustible tobacco
  • Willing to quit using combustible tobacco within the next 2 weeks
  • English-speaking
  • Willing to refrain from smoking any substance, such as cannabis, within 48 hours of expired carbon monoxide collection
  • Willing to complete all intervention components and data collection activities

Exclusion Criteria:

  • Have contraindications for nicotine replacement therapy (NRT)

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): NCT05365633


Contacts
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Contact: Julia McQuoid, PhD (405) 271-6872 ext 50487 julia-mcquoid@ouhsc.edu
Contact: Jan Foisy (405) 271-6872 jan-foisy@ouhsc.edu

Sponsors and Collaborators
University of Oklahoma
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Responsible Party: University of Oklahoma
ClinicalTrials.gov Identifier: NCT05365633    
Other Study ID Numbers: 14472
First Posted: May 9, 2022    Key Record Dates
Last Update Posted: May 9, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: De-identified data will be made available to outside investigators upon request. However, it is noteworthy that data collected as part of the current proposal will be from a small sample, and will not provide sufficient information from which to draw conclusions. Rather these data will support a larger, adequately powered trial, from which data may be more complete and useful to other investigators.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Oklahoma:
sexual and gender minorities
LGBT
empowerment
tobacco use
smoking cessation