NCT06820034PHASE2, PHASE3RecruitingAccepts Healthy Volunteers

Empowering Cessation ACS South Region

University of Oklahoma

Start Date

8/14/2025

Completion Date

12/31/2028

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

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.

Eligibility Criteria

Age Range: 18 years to 100 years

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).

Interventions

OTHER

Empowering Cessation for the ACS South

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Conditions

Smoking Cessation

Locations

University of Oklahoma Health Campus

Oklahoma City, Oklahoma 73104

United States