Empowering Cessation ACS South Region (CHERC)

Empowering Smoking Cessation for People With High Levels of Stress and Low Social Support in Oklahoma and the ACS South Region

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.

Study Overview

• Status: Recruiting
• Conditions: Smoking Cessation
• Intervention / Treatment: Other: Empowering Cessation for the ACS South

Detailed Description

We will enroll 398 participants for the proposed RCT of the intervention. Randomization will occur prior to the onboarding meeting using screening survey responses. We will stratify by gender (cisgender man, cisgender woman, gender minority), sexual orientation (gay/lesbian, bisexual/pansexual/queer, all other sexual orientations), age (18-34 vs. ≥ 35 years old), and state of residence.

In a 2-arm, 12-week randomized controlled trial (RCT) with follow-up at 26 weeks, N=398 SGM adults willing to quit smoking cigarettes will be randomized to a control arm (n=199) (i.e., remote cessation support via the National Cancer Institute's (NCI) smoking cessation app64 and mailed NRT64) or a treatment arm (n=199) that adds online SGM-serving volunteer activity participation (≥4 sessions) and a digital hub to foster social support across sites.

All proposed activities will be conducted remotely (i.e., via phone/text, email, web-based platforms, a private Facebook group, and Zoom video chat) to maximize accessibility and scalability.

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Julia McQuoid, PhD; Phone Number: 405-271-6872; Email: julia-mcquoid@ouhsc.edu
• Study Contact Backup: Name: David Bradley, BA; Phone Number: 405-934-6811; Email: david-bradley@ou.edu

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • Recruiting
      • University of Oklahoma Health Campus
      • Contact: David Bradley, BA; Phone Number: 405-934-6811; Email: david-bradley@ou.edu
      • Contact: Julia McQuoid, PhD; Phone Number: 510-672-0394; Email: julia-mcquoid@ou.edu
      • Principal Investigator: Julia McQuoid, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Exclusion criteria:

• Currently using other smoking cessation treatments.
• Unable or unwilling to use Nicotine Replacement Therapy (NRT)
• Serious psychological distress (i.e., score of 13 ≥ 18 on the Kessler Psychological Distress (PD) Scale-6 19)

Inclusion criteria will be:

1. ≥ 18 years old
2. sexual and/or gender minority-identified (SGM) (see definition below)
3. living in Oklahoma, Texas, or Arkansas (verified by address)
4. a current cigarette smoker (see definition)
5. willing to quit smoking within 30 days of enrollment (see definition)
6. ability to read and speak English 'well' or 'very well'
7. ≥ weekly internet access
8. willing and able to participate in SGM-serving volunteer activities.
9. own a smartphone

Sexual minority identity will be indicated by selecting any non-heterosexual response option(s) from: Heterosexual (Straight); Gay or Lesbian; Bisexual; Something else (please state)." Participants will indicate the sex assigned on their birth certificate (i.e., natal sex). Gender minority identity will be indicated by "Trans male/Trans man;" "Trans female/Trans woman;" "Gender queer/Gender non-conforming;" "Different identity (please state)" or a binary identity (male or female) non-concordant with natal sex.

Current cigarette smoking will be indicated by ≥100 lifetime cigarettes and currently smoking cigarettes "every day" or "some days".

High SGM stigma states are defined as the 22 states wherein ˂60% of the population 'thinks that homosexuality should be accepted'. High SGM stigma municipalities are defined as one of the 246 U.S. municipalities (out of the 496 scored from all U.S. states) that scored below the median (71) on the HRC Municipal Equality Index.

Willingness to quit smoking will be assessed with a single item: "Are you willing to quit smoking cigarettes within 30 days after enrolling in this study? (yes/no)". To be classified as 'ready to quit smoking,' participants will report readiness to quit in the next 30 days and at least 1 past-year quit attempt (i.e., in the "Preparation" stage of change).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoking cessation support + volunteering; This group will receive remotely-delivered smoking cessation support by using the National Cancer Institute's smoking cessation app and receive combination nicotine replacement therapy (NRT; i.e., lozenges/gum, patches). Additionally, they will engage in sexual and/or gender minority (SGM)-serving online volunteer activities (≥4 sessions) and a digital hub to foster interaction across Oklahoma, Texas, and Arkansas.	Other: Empowering Cessation for the ACS South; All participants (N=400) will receive remotely-delivered smoking cessation support comprised of the National Cancer Institute's (NCI) free smoking cessation app and 12 weeks of mailed over-the-counter NRT (nicotine patches, gum or lozenges).. While receiving smoking cessation support, participants in the intervention group (n=200) will also engage in SGM-serving online volunteer activities (≥4 weekly sessions lasting ~1.5 hours each), the protocols for which will be developed in Phase 1 to address the needs of OK, AR, and TX communities. Volunteer sessions will be facilitated by an SGM culturally-competent facilitator employed by the research team (i.e., community partner organizations will not run volunteer sessions). The intervention group will also be added to a digital hub (i.e., a private Reddit group) for 12 weeks to foster social support and exchange of ideas between participants/community partners across the three states.
No Intervention: Smoking cessation support ONLY; Participants in this group will receive remotely-delivered smoking cessation support by using the National Cancer Institute's smoking cessation app and receive combination nicotine replacement therapy (NRT; i.e., lozenges/gum, patches).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically-verified 7-day Point Prevalence Abstinence (PPA) at 26 weeks	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.	26 weeks post-quit-date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Social Support	Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale. 5-point Likert scale; Strongly disagree = least support ... Strongly agree = most support	Week 0; Week 12
Smoking intensity	-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	Week 0, Week 12, Week 26
Adaptive coping with minority stress	Brief- Coping Orientation to Problems Experienced Inventory (COPE) [adapted] 5-point Likert scale; Strongly disagree to Strongly agree. Higher score = more coping	Week 0; Week 12
Self-efficacy	-Self-Efficacy Scale/Confidence (SESC) Scale of 10 Very confident to 1 not at all confident. Higher score = greater self-efficacy to quit smoking	Week 0, Week 12, Week 26
Motivation to quit smoking	-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	Week 0, Week 12, Week 26
Internalized transphobia	Gender Minority Stress and Resilience: Internalized transphobia subscale 5-point Likert scale; Strongly disagree to Strongly agree Higher score = greater internalized transphobia	Week 0; Week 12
Prosociality	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	Week 0; Week 12
Nicotine Replacement Therapy (NRT) Adherence	Medication Adherence Questionnaire (MAQ) Yes=0; No=1; higher score = greater adherence	Weeks 1, 3, 5, 7, 9, 11
Smoking cessation app engagement	Self-report of number of times per day participant opened app, on average, over the past week. Greater number of times opened = greater engagement	Weeks 3, 5, 7, 9, 11
Intervention satisfaction	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	Weeks 3, 5, 7, 9, 12
Sexual Orientation Identity Pride	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	Week 0, Week 12
Gender identity and expression pride	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	Week 0, Week 12

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Investigators: Principal Investigator: Julia McQuoid, PhD, University of Oklahoma

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: February 5, 2025
• First Posted (Actual): February 11, 2025

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: smoking cessation
• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation
• Other Study ID Numbers: 17874; 1181502 (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No