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NCT Number: NCT06820034

Empowering Cessation 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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Empowering Cessation for the ACS South

Other

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.

Primary outcomes

  1. Biochemically-verified 7-day Point Prevalence Abstinence (PPA) at 26 weeks

    Time frame: 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 outcomes

  1. Social Support

    Time frame: 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

  2. Smoking intensity

    Time frame: 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

  3. Adaptive coping with minority stress

    Time frame: 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

  4. Self-efficacy

    Time frame: 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

  5. Motivation to quit smoking

    Time frame: 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

  6. Internalized transphobia

    Time frame: 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

  7. Prosociality

    Time frame: 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

  8. Nicotine Replacement Therapy (NRT) Adherence

    Time frame: Weeks 1, 3, 5, 7, 9, 11

    Medication Adherence Questionnaire (MAQ) Yes=0; No=1; higher score = greater adherence

  9. Smoking cessation app engagement

    Time frame: 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

  10. Intervention satisfaction

    Time frame: 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

  11. Sexual Orientation Identity Pride

    Time frame: 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

  12. Gender identity and expression pride

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

David Bradley, BA

CONTACT

[email protected]

405-934-6811

Julia McQuoid, PhD

CONTACT

[email protected]

405-271-6872

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

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

Acronym: CHERC

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Feb 11, 2025
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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