Empowering LGBTQ+ Tobacco Cessation Pilot
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|ClinicalTrials.gov Identifier: NCT05365633|
Recruitment Status : Not yet recruiting
First Posted : May 9, 2022
Last Update Posted : May 9, 2022
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Empowerment activity-enhanced tobacco cessation assistance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single-arm pilot design|
|Masking:||None (Open Label)|
|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|
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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
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
|Contact: Julia McQuoid, PhD||(405) 271-6872 ext firstname.lastname@example.org|
|Contact: Jan Foisy||(405) email@example.com|