Trial Outcomes & Findings for Empowering LGBTQ+ Tobacco Cessation Pilot (NCT NCT05365633)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

12-weeks post-quit

Results posted on

2025-05-15

Participant Flow

Participants were recruited online from Oklahoma and consented online August 2022 - September 2023.

20 participants signed consent, were fully enrolled, and were randomized to the intervention.

Participant milestones

Participant milestones
Measure	Empowerment Activity-enhanced Tobacco Cessation Assistance Single arm pilot intervention design to assess feasibility and acceptability 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 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.
Overall Study STARTED	20
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Empowering LGBTQ+ Tobacco Cessation Pilot

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Empowerment Activity-enhanced Tobacco Cessation Assistance n=20 Participants Single arm pilot intervention design to assess feasibility and acceptability 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 nicotine replacement therapy (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 volunteer activities) 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.
Sex: Female, Male Male	16 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	15 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black/African American	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Indigenous Peoples, Native American, Alaskan Native	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Middle Eastern or North African	1 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	39.5 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12-weeks post-quit

Population: Treatment group in a single-arm pilot trial

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.

Outcome measures

Outcome measures
Measure	Empowerment Activity-enhanced Tobacco Cessation Assistance n=20 Participants Single arm pilot intervention design to assess feasibility and acceptability 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 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. follow-up surveying of Freedom OK's name and gender marker change clinic72 participants.
Retention	16 Participants

PRIMARY outcome

Timeframe: 12 weeks post-quit-date

Population: Participants who completed an exit survey.

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.

Outcome measures

Outcome measures
Measure	Empowerment Activity-enhanced Tobacco Cessation Assistance n=16 Participants Single arm pilot intervention design to assess feasibility and acceptability 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 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. follow-up surveying of Freedom OK's name and gender marker change clinic72 participants.
Number of Participants Endorsing That They Would Recommend This Intervention to Another LGBTQ2S+ Identified Person Who Wants to Quit Smoking	13 Participants

PRIMARY outcome

Timeframe: within 1 month of data collection completion

Population: Interviews were conducted with 2 staff members from the community partner organization.

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.

Outcome measures

Outcome measures
Measure	Empowerment Activity-enhanced Tobacco Cessation Assistance n=2 Participants Single arm pilot intervention design to assess feasibility and acceptability 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 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. follow-up surveying of Freedom OK's name and gender marker change clinic72 participants.
Number of Community Partner Staff Who Perceived Their Organization's Partnership on the Intervention as Beneficial	2 Participants

PRIMARY outcome

Timeframe: 12 weeks post-quit-date

Population: Participants who completed an exit survey.

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.

Outcome measures

Outcome measures
Measure	Empowerment Activity-enhanced Tobacco Cessation Assistance n=16 Participants Single arm pilot intervention design to assess feasibility and acceptability 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 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. follow-up surveying of Freedom OK's name and gender marker change clinic72 participants.
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)	11 Participants

PRIMARY outcome

Timeframe: 12 weeks post-quit-date

Population: Participants who completed an exit survey.

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.

Outcome measures

Outcome measures
Measure	Empowerment Activity-enhanced Tobacco Cessation Assistance n=16 Participants Single arm pilot intervention design to assess feasibility and acceptability 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 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. follow-up surveying of Freedom OK's name and gender marker change clinic72 participants.
Number of Participants Attending at Least 4 Smoking Cessation Counseling Sessions	14 Participants

PRIMARY outcome

Timeframe: 12 weeks post-quit-date

Population: Participants who completed an exit survey.

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.

Outcome measures

Outcome measures
Measure	Empowerment Activity-enhanced Tobacco Cessation Assistance n=16 Participants Single arm pilot intervention design to assess feasibility and acceptability 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 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. follow-up surveying of Freedom OK's name and gender marker change clinic72 participants.
Number of Participants Attending at Least 4 Volunteer Sessions	10 Participants

SECONDARY outcome

Timeframe: 12 weeks post-quit-date

Population: Participants who started the intervention by completing at least one volunteer session or at least one counseling session.

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.

Outcome measures

Outcome measures
Measure	Empowerment Activity-enhanced Tobacco Cessation Assistance n=20 Participants Single arm pilot intervention design to assess feasibility and acceptability 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 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. follow-up surveying of Freedom OK's name and gender marker change clinic72 participants.
Number of Participants Self-reporting 7-day Point Prevalence Abstinence at Week 12	9 Participants

SECONDARY outcome

Timeframe: 12 weeks post-quit-date

Population: Technical problems hindered biochemical verification. The iCOTM Smokerlyzer carbon monoxide monitor smartphone app was incompatible with a newer Android operating system used by at least 7 participants. The team attempted to verify abstinence using in-person carbon monoxide devices (Vitalograph Model 2900 BreathCOTM), but due to participants' remote locations, readings were only obtained for 8/16 exit survey respondents. Of those 8, 5 participants self-reported smoking abstinence at week 12.

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).

Outcome measures

Outcome measures
Measure	Empowerment Activity-enhanced Tobacco Cessation Assistance n=5 Participants Single arm pilot intervention design to assess feasibility and acceptability 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 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. follow-up surveying of Freedom OK's name and gender marker change clinic72 participants.
Number of Participants for Whom Self-reported Smoking Abstinence is Biochemically-verified	4 Participants

SECONDARY outcome

Timeframe: baseline and 12 weeks post-quit-date

Population: Participants who completed an exit survey at week 12.

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.

Outcome measures

Outcome measures
Measure	Empowerment Activity-enhanced Tobacco Cessation Assistance n=16 Participants Single arm pilot intervention design to assess feasibility and acceptability 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 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. follow-up surveying of Freedom OK's name and gender marker change clinic72 participants.
Number of Participants Who Reported an Increase in Adaptive Coping From Baseline to Exit	1 Participants

Adverse Events

Empowerment Activity-enhanced Tobacco Cessation Assistance

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Julia McQuoid

University of Oklahoma

Phone: 405-271-8001

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place