Empowering LGBTQ+ Tobacco Cessation Pilot

NCT05365633 | Completed Results

• 1 other identifier: 14472
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Smoking Cessation

Keywords

sexual and gender minorities; LGBT; empowerment; tobacco use; smoking cessation

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  12 weeks post-quit-date

Secondary Outcomes (3)

• Number of Participants Self-reporting 7-day Point Prevalence Abstinence at Week 12

  12 weeks post-quit-date

• Number of Participants for Whom Self-reported Smoking Abstinence is Biochemically-verified

  12 weeks post-quit-date

• Number of Participants Who Reported an Increase in Adaptive Coping From Baseline to Exit

  baseline and 12 weeks post-quit-date

Study Arms (1)

Empowerment activity-enhanced tobacco cessation assistance

OTHER

Single arm pilot intervention design to assess feasibility and acceptability

Behavioral: Empowerment activity-enhanced tobacco cessation assistance

Interventions

Empowerment activity-enhanced tobacco cessation assistance BEHAVIORAL

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.

Empowerment activity-enhanced tobacco cessation assistance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Have contraindications for nicotine replacement therapy (NRT)

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

Health Promotion Research Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Coitus; Empowerment; Tobacco Use

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Sexual Behavior; Social Behavior

Results Point of Contact

• Title: Dr. Julia McQuoid
• Organization: University of Oklahoma

julia-mcquoid@ouhsc.edu

405-271-8001

Study Officials

• Julia McQuoid, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm pilot design

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: May 9, 2022
• Study Start: August 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: January 11, 2024
• Last Updated: May 15, 2025
• Results First Posted: May 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)