Empowering Smoking Cessation for People With High Levels of Stress and Low Social Support in Oklahoma and the ACS South Region
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Biochemically-verified 7-day Point Prevalence Abstinence (PPA) at 26 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥ 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).
排除标准
- 未提供
研究组 & 干预措施
Smoking cessation support + volunteering
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.
干预措施: Empowering Cessation for the ACS South (Other)
Smoking cessation support ONLY
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).
结局指标
主要结局
Biochemically-verified 7-day Point Prevalence Abstinence (PPA) at 26 weeks
时间窗: 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.
次要结局
- Self-efficacy(Week 0, Week 12, Week 26)
- Motivation to quit smoking(Week 0, Week 12, Week 26)
- Internalized transphobia(Week 0; Week 12)
- Prosociality(Week 0; Week 12)
- Nicotine Replacement Therapy (NRT) Adherence(Weeks 1, 3, 5, 7, 9, 11)
- Sexual Orientation Identity Pride(Week 0, Week 12)
- Adaptive coping with minority stress(Week 0; Week 12)
- Social Support(Week 0; Week 12)
- Smoking intensity(Week 0, Week 12, Week 26)
- Smoking cessation app engagement(Weeks 3, 5, 7, 9, 11)
- Gender identity and expression pride(Week 0, Week 12)
- Intervention satisfaction(Weeks 3, 5, 7, 9, 12)