Empowering Cessation ACS South Region

NCT06820034 | Recruiting Phase 2

• 2 other identifiers: 178741181502
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Keywords

smoking cessation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Social Support

  Week 0; Week 12

• Smoking intensity

  Week 0, Week 12, Week 26

• Adaptive coping with minority stress

  Week 0; Week 12

• Self-efficacy

  Week 0, Week 12, Week 26

• Motivation to quit smoking

  Week 0, Week 12, Week 26

Study Arms (2)

Smoking cessation support + volunteering

EXPERIMENTAL

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

Smoking cessation support ONLY

NO INTERVENTION

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).

Interventions

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.

Smoking cessation support + volunteering

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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)
• ≥ 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Campus

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Julia McQuoid, PhD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia McQuoid, PhD

CONTACT

405-271-6872; julia-mcquoid@ouhsc.edu

David Bradley, BA

CONTACT

405-934-6811; david-bradley@ou.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 11, 2025
• Study Start: August 14, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)