Empowering Cessation ACS South Region

Official title

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

Overview

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.

Interventions

• 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 addr

Primary outcome measures

• Biochemically-verified 7-day Point Prevalence Abstinence (PPA) at 26 weeks [Time frame: 26 weeks post-quit-date]

Secondary outcome measures (12)

• Social Support [Time frame: Week 0; Week 12]
• Smoking intensity [Time frame: Week 0, Week 12, Week 26]
• Adaptive coping with minority stress [Time frame: Week 0; Week 12]
• Self-efficacy [Time frame: Week 0, Week 12, Week 26]
• Motivation to quit smoking [Time frame: Week 0, Week 12, Week 26]
• Internalized transphobia [Time frame: Week 0; Week 12]
• Prosociality [Time frame: Week 0; Week 12]
• Nicotine Replacement Therapy (NRT) Adherence [Time frame: Weeks 1, 3, 5, 7, 9, 11]
• Smoking cessation app engagement [Time frame: Weeks 3, 5, 7, 9, 11]
• Intervention satisfaction [Time frame: Weeks 3, 5, 7, 9, 12]
• Sexual Orientation Identity Pride [Time frame: Week 0, Week 12]
• Gender identity and expression pride [Time frame: Week 0, Week 12]

Eligibility criteria

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:

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Oklahoma Health Campus — Oklahoma City

Identifiers

NCT: NCT06820034 · 17874 · 1181502

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗