Empowering Cessation ACS South Region

Phase 1

Not yet recruiting

• Conditions: Smoking Cessation

• Registration Number: NCT06820034
• Lead Sponsor: University of Oklahoma

Brief Summary

Sexual and/or gender minority (SGM) people face a disproportionate burden of cancer risk, and tobacco use is a key modifiable risk factor. SGM tobacco-related disparities are especially pronounced in places with high levels of stigma against SGM people. This community-engaged and remotely-delivered Research Scholar Grant project will evaluate an empowerment-based smoking cessation intervention tailored for SGM people in high-stigma places. In partnership with Freedom Oklahoma (OK) and a Community Advisory Board from Arkansas (AR) and Texas (TX) this projects aims to: (1) Adapt SGM-serving volunteer activities from the Oklahoma intervention pilot study for delivery in nearby states; (2) Test intervention efficacy among SGM adults in OK, AR, and TX; (3) Identify treatment mechanisms.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-28
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Study Start: 2025-06-01
• Primary Completion: 2028-06-01
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biochemically-verified 7-day Point Prevalence Abstinence (PPA) at 26 weeks	26 weeks post-quit-date	Self-reported smoking cessation abstinence will be biochemically verified with the iCOQuit Smokerlyzer expired carbon monoxide device 26 weeks after the participant's quit smoking date.

Secondary Outcome Measures

Name	Time	Method
Self-efficacy	Week 0, Week 12, Week 26	-Self-Efficacy Scale/Confidence (SESC) Scale of 10 Very confident to 1 not at all confident. Higher score = greater self-efficacy to quit smoking
Motivation to quit smoking	Week 0, Week 12, Week 26	-Motivation to change (Stages of Change \[SoC\] scale) 0 (Not at all ready)-----------------------10 (Extremely ready/already quit) Higher score = more motivation to quit smoking
Internalized transphobia	Week 0; Week 12	Gender Minority Stress and Resilience: Internalized transphobia subscale 5-point Likert scale; Strongly disagree to Strongly agree Higher score = greater internalized transphobia
Prosociality	Week 0; Week 12	Well-Being in Prosociality \[Chi K, Almeida DM, Charles ST, et al. Daily prosocial activities and well-being: Age moderation in two national studies. Psychology and Aging 2021;36(1):83.\] 5-point Likert Scale: Strongly agree to Strongly disagree Higher score indicates greater prosociality
Nicotine Replacement Therapy (NRT) Adherence	Weeks 1, 3, 5, 7, 9, 11	Medication Adherence Questionnaire (MAQ) Yes=0; No=1; higher score = greater adherence
Sexual Orientation Identity Pride	Week 0, Week 12	Lesbian, Gay, and Bisexual Identity Scales: Identity Concealment Motivation subscale; Internalized Homonegativity; Identity Acceptance Concerns 6-point scale: 1=Disagree strongly... 6=Strongly agree Higher score = greater identity concerns
Adaptive coping with minority stress	Week 0; Week 12	Brief- Coping Orientation to Problems Experienced Inventory (COPE) \[adapted\]; 5-point Likert scale; Strongly disagree to Strongly agree. Higher score = more coping
Social Support	Week 0; Week 12	Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale.; 5-point Likert scale; Strongly disagree = least support ... Strongly agree = most support
Smoking intensity	Week 0, Week 12, Week 26	-Smoking intensity will be assessed by past-week smoking days and past-week cigarettes per smoking day.; Greater number of smoking days and great number of cigarettes per day = greater smoking intensity
Smoking cessation app engagement	Weeks 3, 5, 7, 9, 11	Self-report of number of times per day participant opened app, on average, over the past week. Greater number of times opened = greater engagement
Gender identity and expression pride	Week 0, Week 12	Gender Minority Stress and Resilience: Gender Identity \& Expression Pride subscale 5-point Likert scale; Strongly disagree to Strongly agree Higher score = greater gender identity and expression pride
Intervention satisfaction	Weeks 3, 5, 7, 9, 12	Validated measures of intervention feasibility, acceptability, and appropriateness (Weiner et al, 2017) 5 point ordinal scale from "completely disagree=0" to "completely agree=4"; higher score = greater intervention satisfaction