Smoking CessationNCT05365633
Empowering LGBTQ+ Tobacco Cessation Pilot
A study testing Empowerment activity-enhanced tobacco cessation assistance in people with Smoking Cessation, run by University of Oklahoma at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Empowerment activity-enhanced tobacco cessation assistance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 11 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Have contraindications for nicotine replacement therapy (NRT)
Trial locations and contacts
1 site in 1 country.
United States1 site
Health Promotion Research Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Empowering Sexual and/or Gender Minority Tobacco Cessation: A Pilot Study
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 conducting follow-up phone calls to name change clinic participants. 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.
Read the 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 skills. Examples are compiling publicly-available school board information to make it easier for community members to participate in their school districts and follow-up phone calls to Freedom OK's name correction clinic 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 ET 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).
- Conditions
- Smoking Cessation
- Being tested
- Empowerment activity-enhanced tobacco cessation assistance
- Keywords
- sexual and gender minorities, LGBT, empowerment, tobacco use, smoking cessation
- Medical subject headings
- Smoking Cessation, Coitus, Empowerment, Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowerment activity-enhanced tobacco cessation assistanceBehavioural
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 skills. Examples are compiling publicly-available information about school board meetings to support community members in participating in their school districts and making follow-up phone calls with a script to Freedom OK's name change clinic participants.
| Study group | Role | What they receive |
|---|---|---|
| Empowerment activity-enhanced tobacco cessation assistance | Other | Single arm pilot intervention design to assess feasibility and acceptability Receives: Behavioral: Empowerment activity-enhanced tobacco cessation assistance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
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.
Measured: 12-weeks post-quit
Number of Participants Endorsing That They Would Recommend This Intervention to Another LGBTQ2S+ Identified Person Who Wants to Quit Smoking
Intervention acceptability will be assessed by the participant endorsing that they would recommend this intervention to another LGBTQ2S+ identified person who wants to quit smoking.
Measured: 12 weeks post-quit-date
Number of Community Partner Staff Who Perceived Their Organization's Partnership on the Intervention as Beneficial
We will qualitatively assess community partner perceptions of their organization's partnership on the intervention as beneficial 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.
Measured: within 1 month of data collection completion
Number of Participants Having Had ≥ 2 Weeks With Moderate to High Adherence to the Nicotine Patch Assessed With the 4-item Medication Adherence Questionnaire (MAQ)
Treatment adherence will be assessed with the 4-item Medication Adherence Questionnaire (MAQ) and counseling session attendance tracking. The benchmark for satisfactory medication treatment adherence is having had ≥ 2 weeks with moderate to high adherence to the nicotine patch.
Measured: 12 weeks post-quit-date
Number of Participants Attending at Least 4 Smoking Cessation Counseling Sessions
Counseling attendance will be assessed by tracking the proportion of counseling sessions attended by each participant by 12 weeks post-quit-date. The benchmark for satisfactory attendance is attending at least 4 counseling sessions.
Measured: 12 weeks post-quit-date
Number of Participants Attending at Least 4 Volunteer Sessions
Volunteer session attendance will be assessed by tracking the proportion of sessions attended by each participant by 12 weeks post-quit-date. The benchmark for satisfactory attendance is attending at least 4 sessions.
Measured: 12 weeks post-quit-date
Secondary outcomes (3)
Number of Participants Self-reporting 7-day Point Prevalence Abstinence at Week 12
Participant self-report of smoking abstinence within the past 7 days upon intervention exit. Participants who did not complete an exit survey are assumed to be smoking (i.e., not abstinent) at week 12.
Measured: 12 weeks post-quit-date
Number of Participants for Whom Self-reported Smoking Abstinence is Biochemically-verified
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 weeks).
Measured: 12 weeks post-quit-date
Number of Participants Who Reported an Increase in Adaptive Coping From Baseline to Exit
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.
Measured: baseline and 12 weeks post-quit-date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start1 Aug 2022
- Primary completion1 Sep 2023
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm pilot design
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julia McQuoid, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05365633
- Sponsor's protocol ID
- 14472
- Status last verified
- Apr 2025
- First submitted
- 12 Apr 2022
- Last updated
- 15 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Sexual and/or Gender Minority Tobacco Cessation: A Pilot Study
- ClinicalTrials.gov ID
- NCT05365633
- Acronym / sponsor ID
- 14472
- Conditions
- Smoking Cessation
- Keywords
- sexual and gender minorities, LGBT, empowerment, tobacco use, smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 9 May 2022 (actual)
- Results
- Posted 15 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 conducting follow-up phone calls to name change clinic participants. 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 skills. Examples are compiling publicly-available school board information to make it easier for community members to participate in their school districts and follow-up phone calls to Freedom OK's name correction clinic 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 ET 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm pilot design
| Arm | Type | Receives |
|---|---|---|
| Empowerment activity-enhanced tobacco cessation assistance | Other | Behavioral: Empowerment activity-enhanced tobacco cessation assistanceSingle arm pilot intervention design to assess feasibility and acceptability |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Have contraindications for nicotine replacement therapy (NRT)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowerment activity-enhanced tobacco cessation assistanceParticipants 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 skills. Examples are compiling publicly-available information about school board meetings to support community members in participating in their school districts and making follow-up phone calls with a script to Freedom OK's name change clinic participants. | Behavioural | Empowerment activity-enhanced tobacco cessation assistance |
Primary outcome
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.
Number of Participants Endorsing That They Would Recommend This Intervention to Another LGBTQ2S+ Identified Person Who Wants to Quit Smoking
Time frame: 12 weeks post-quit-date
Intervention acceptability will be assessed by the participant endorsing that they would recommend this intervention to another LGBTQ2S+ identified person who wants to quit smoking.
Number of Community Partner Staff Who Perceived Their Organization's Partnership on the Intervention as Beneficial
Time frame: within 1 month of data collection completion
We will qualitatively assess community partner perceptions of their organization's partnership on the intervention as beneficial 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.
Number of Participants Having Had ≥ 2 Weeks With Moderate to High Adherence to the Nicotine Patch Assessed With the 4-item Medication Adherence Questionnaire (MAQ)
Time frame: 12 weeks post-quit-date
Treatment adherence will be assessed with the 4-item Medication Adherence Questionnaire (MAQ) and counseling session attendance tracking. The benchmark for satisfactory medication treatment adherence is having had ≥ 2 weeks with moderate to high adherence to the nicotine patch.
Number of Participants Attending at Least 4 Smoking Cessation Counseling Sessions
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. The benchmark for satisfactory attendance is attending at least 4 counseling sessions.
Number of Participants Attending at Least 4 Volunteer Sessions
Time frame: 12 weeks post-quit-date
Volunteer session attendance will be assessed by tracking the proportion of sessions attended by each participant by 12 weeks post-quit-date. The benchmark for satisfactory attendance is attending at least 4 sessions.
3 secondary outcomes
Number of Participants Self-reporting 7-day Point Prevalence Abstinence at Week 12
Time frame: 12 weeks post-quit-date
Number of Participants for Whom Self-reported Smoking Abstinence is Biochemically-verified
Time frame: 12 weeks post-quit-date
Number of Participants Who Reported an Increase in Adaptive Coping From Baseline to Exit
Time frame: baseline and 12 weeks post-quit-date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia McQuoid, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowerment activity-enhanced tobacco cessation assistance in people with Smoking Cessation, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 12-weeks post-quit). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.