Empowering Cessation ACS South Region
ConditionSmoking Cessation
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Oklahoma
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Empowering Cessation for the ACS South
Other interventionAll 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Smoking cessation support + volunteeringExperimental treatment 1 intervention
Group B: Smoking cessation support ONLYNo intervention 0 interventions
Trial outcomes
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.
Time frame
26 weeks post-quit-dateSecondary outcomes
1
Social Support
Patient-Reported Outcomes Measurement Information System (PROMIS) emotional support scale. 5-point Likert scale; Strongly disagree = least support ... Strongly agree = most support
Time frame
Week 0; Week 122
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
Time frame
Week 0, Week 12, Week 263
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
Time frame
Week 0; Week 124
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
Time frame
Week 0, Week 12, Week 26Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov