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History of Changes for Study: NCT05365633
Empowering LGBTQ+ Tobacco Cessation Pilot
Latest version (submitted May 3, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 May 3, 2022 None (earliest Version on record)
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Study NCT05365633
Submitted Date:  May 3, 2022 (v1)

Open or close this module Study Identification
Unique Protocol ID: 14472
Brief Title: Empowering LGBTQ+ Tobacco Cessation Pilot
Official Title: Empowering Sexual and/or Gender Minority Tobacco Cessation: A Pilot Study
Secondary IDs:
Open or close this module Study Status
Record Verification: May 2022
Overall Status: Not yet recruiting
Study Start: June 1, 2022
Primary Completion: October 1, 2022 [Anticipated]
Study Completion: October 1, 2022 [Anticipated]
First Submitted: April 12, 2022
First Submitted that
Met QC Criteria:
May 3, 2022
First Posted: May 9, 2022 [Actual]
Last Update Submitted that
Met QC Criteria:
May 3, 2022
Last Update Posted: May 9, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Oklahoma
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module Study Description
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.
Detailed Description:

Aim 1: Assess the feasibility and acceptability of empowerment-enhanced tobacco cessation assistance for sexual and/or gender minority (SGM) adults. Use baseline and exit surveys and in-depth interviews to assess retention, empowerment activity participation (e.g., number, duration, intensity, roles), and participants' perceptions of the intervention.

Aim 2: Compare individual empowerment and cessation predictors pre- and post-intervention. Hypothesis: Post intervention, participants will have (i) increased adaptive coping strategies, social support, and smoking abstinence self-efficacy; and (ii) decreased internalized SGM stigma.

Aim 3: Assess tobacco cessation outcomes post-intervention. Hypothesis: The proportion of participants with biochemically-verified smoking abstinence at 12 weeks post-quit-date will be equal to or greater than the general Stephenson Cancer Center Tobacco Treatment research Program (TTRP) intervention (i.e., 18% biochemically-verified abstinence at 12 weeks1); medication and counseling adherence will be moderate/optimal for >50% of treatment weeks.

Study overview. This study will assess the feasibility and acceptability of empowerment-enhanced tobacco cessation assistance for SGM adults. A single-arm pilot design will be used given funding, time, and sampling pool limits. Participants (N=20) will receive standard TTRP tobacco cessation assistance and concurrently participate in SGM empowerment activities. Outcomes will be assessed quantitatively and qualitatively. Primary outcome variables will be retention, perceptions of the intervention, adaptive coping strategies, biochemically-verified smoking abstinence at 12 weeks post-quit-date, and treatment adherence.

Recruitment. Participants will be enrolled over a 4-month period and recruit through the TTRP, which serves an average of 30 SGM individuals per year without SGM-targeted recruitment. This will be supplement by recruiting via local SGM-serving organizations, SGM targeted social media ads (e.g., Facebook), and snowball recruitment.

Intervention. Participants will receive standard 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.

Participants will complete the following assessments: (i) 8 surveys (baseline, exit, quit-day, 1-4 and 12 weeks post-quit-date); (ii) biochemically-verified smoking status at baseline and 12 weeks post-quit-date via expired carbon monoxide monitors; and (iii) a 60-minute in-depth interview over Zoom video chat within weeks 6-8 post-quit-date. Participants will be incentivized a total of $200 for the baseline survey ($25), 6 subsequent surveys ($70), 2 expired carbon monoxide tests ($20), exit survey ($25), and 60-minute interview ($60). Freedom Oklahoma staff will participate in interviews and reflect on the intervention and Freedom OK's role in it. Freedom Oklahoma will adopt a tobacco-free policy and provide feedback on the cultural competence of TTRP materials.

Partnerships. TTRP will provide the standard tobacco cessation assistance. Freedom Oklahoma will design the empowerment activities. Freedom Oklahoma is a community-based organization in Oklahoma City that has worked to secure lived equality and legal protection for SGM Oklahomans for over 15 years. PI McQuoid and Freedom OK have held more than 4 project planning meetings over the past year.

Measurement of Feasibility and Acceptability (Aim 1). Exit surveys administered via REDCap will be used to assess retention and self-reported empowerment activity participation (i.e., total hours, types of events/activities, roles played).73 This will be cross-referenced with research project records of empowerment activity participation. Perceptions of the intervention will be qualitatively assessed by interviewing participants over Zoom video chat at 12 weeks post-quit-date. PI McQuoid, a qualitative methods expert, will train a team to conduct semi-structured, in-depth interviews lasting approximately 60 minutes. Rich content will be elicited regarding experiences of empowerment activity participation and tobacco cessation as an SGM person in Oklahoma. 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. Interviews will be audio-recorded and professionally transcribed verbatim.

Qualitative Analysis: Dedoose qualitative data analysis software will be used to conduct an inductive-deductive thematic transcript analysis with a priori themes derived from ET39-42,45-47,73 and SGM tobacco cessation literature.33-35 An iterative codebook development process will be used involving weekly team discussions, independent coding, and member checking of findings74 to enhance rigor and trustworthiness.75,76 Freedom Oklahoma staff will also be interviewed about their perceptions of the intervention and their organization's role in it.

Measurement of Individual Empowerment and Cessation Predictors (Aim 2). Individual empowerment and cessation predictors pre- and post-intervention will be compared with baseline and exit surveys. Predictors of smoking cessation51-54,77,78 and individual empowerment outcome measures will be compared, adapted from a youth empowerment tobacco control model42,73 and SGM social change mobilization participation research.48 These will include: (i) adaptive coping strategies (Cognitive Emotion Regulation Questionnaire79), (ii) (v) social support (Relational Health Indices80), (iii) abstinence self-efficacy (Confidence Inventory81), and (iv) internalized SGM stigma (Internalized Transphobia and Pride82 and Internalized Homophobia items83).

Measurement of Tobacco Cessation Outcomes (Aim 3). Benchmarks will be used to assess participants' tobacco cessation outcomes. Tobacco abstinence will be measured via self-report and biochemically-verified via expired carbon monoxide at baseline and 12 weeks post-quit-date. Treatment adherence will be assessed with the 4-item Medication Adherence Questionnaire (MAQ)84 and counseling session attendance tracking.

Sample Size/Analysis Plan. Primary outcome variables will be: retention, perceptions of the intervention, adaptive coping strategies, biochemical verification of tobacco abstinence at 12 weeks post-quit-date, and treatment adherence. Retention will be evaluated 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. Perceptions of the intervention will be qualitatively evaluated (as described above). A two-sided paired samples t-test will be used to examine the mean differences in adaptive coping strategies pre- and post-intervention (α=0.05). Assuming 20% attrition and 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. 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 TTRP sample (i.e., 18% at 12 weeks1). Treatment adherence will be considered successful with all participants having >50% of treatment weeks with an MAQ score indicating moderate/high adherence and counseling session attendance.

Expected outcomes: Empowerment-enhanced tobacco cessation assistance will be acceptable and feasible (Aim 1), will increase within-subject empowerment and improve cessation predictors (Aim 2), and will meet benchmarks for tobacco cessation outcomes (Aim 3).

Open or close this module Conditions
Conditions: Smoking Cessation
Keywords: sexual and gender minorities
LGBT
empowerment
tobacco use
smoking cessation
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
Single-arm pilot design
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
Open or close this module Outcome Measures
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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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)
Open or close this module Contacts/Locations
Central Contact Person: Julia McQuoid, PhD
Telephone: (405) 271-6872 Ext. 50487
Email: julia-mcquoid@ouhsc.edu
Central Contact Backup: Jan Foisy
Telephone: (405) 271-6872
Email: jan-foisy@ouhsc.edu
Locations:
Open or close this module IPDSharing
Plan to Share IPD: Undecided
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.
Open or close this module References
Citations:
Links:
Available IPD/Information:

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