Adapting the FOCUS Program for Sexual and Gender Minority (SGM) Cancer Patients and Caregivers

项目摘要 本项目的目标是适应经验性验证的焦点干预，并测试其可行性和 性和性别少数(SGM)癌症患者及其照顾者的可接受性。SGM癌 患者面临着尚未解决的挑战，这些挑战对他们的生活质量(QOL)产生了不利影响，包括少数族裔压力， 或者，由于生活在被污名化的SGM身份中而产生的长期压力。此外，SGM的照顾者 在主要为异性/顺性别服务的医疗系统中，患者往往得不到承认 (H/C)患者；H/C患者照顾者的资源通常不能满足他们的需求；SGM患者可能 更有可能依赖SGM的朋友或前伴侣作为照顾者；这些多样化的SGM照顾者可能是 在癌症护理环境中受到少数族裔压力的影响。需要心理教育干预来解决这些问题 并共同改善SGM癌症患者及其照顾者的生活质量。焦点干预 同时使用心理教育和问题解决来改善癌症患者的生活质量、应对方式和自我效能 以及他们的照顾者，并在之前的三次临床试验中被证明是有效的。然而，正如我们注意到的那样， SGM社区合作伙伴LGBT癌症行动委员会(CAC)，其内容尚未针对SGM量身定做 两性关系。因此，我们建议将循证焦点计划用于SGM癌症 患者及其照顾者(目标1)。与LGBT CAC合作并由跨理论 SGM-积极适应模式和适应-ITT框架，我们将与≥24 SGM开展6个焦点小组 癌症患者和他们的≥24照顾者将“剧场测试”焦点，并获得有关适应的定性反馈。 我们还将从SGM研究的5个主题专家小组中收集反馈，并创建一个手册化的、适应的 干预措施被称为Focus-SGM。然后，我们将评估可行性和可接受性，并探索潜力 调整后的Focus-SGM干预在双臂试点试验中的结果(目标2)。我们将随机抽取80名 SGM癌症患者和他们的照顾者(总N≥160)将Focus-SGM或等待名单对照。评估 患者和照顾者将在基线、干预后和3个月(~6个月)的随访中发生 基线之后)。我们假设招募SGM癌症患者和照顾者的样本是可行的 通过诊所、社区和在线方式；至少80%的SGM患者和照顾者将高度 对Focus-SGM的内容和交付感到满意；75%的人将完成3次或更多的Focus-SGM会议； 75%的人将完成干预后和3个月的随访评估。我们还将探索是否 潜在的结果测量(生活质量、应对、管理癌症的自我效能、关系沟通和 少数应激)对焦点-SGM和对照的影响作出反应。这笔赠款代表着关键的一步 在准备我们的团队进行Focus-SGM的最终试验时，响应社区和NCI的优先事项， 并有可能解决SGM人群的生活质量差距。

PROJECT ABSTRACT The goal of this project is to adapt the empirically-validated FOCUS intervention and test its feasibility and acceptability among sexual and gender minority (SGM) cancer patients and their caregivers. SGM cancer patients face unaddressed challenges that adversely impact their quality of life (QOL), including minority stress, or the chronic stress engendered by living with a stigmatized SGM identity. Furthermore, caregivers of SGM patients are often not acknowledged in healthcare systems primarily designed to serve heterosexual/cisgender (H/C) patients; resources for caregivers of H/C patients often do not address their needs; SGM patients may be more likely to rely on SGM friends or ex-partners as caregivers; and these diverse SGM caregivers may be affected by minority stress in cancer care settings. Psychoeducational interventions are needed to address these disparities and improve the QOL of SGM cancer patients and their caregivers together. The FOCUS intervention uses both psychoeducation and problem solving to improve QOL, coping, and self-efficacy in cancer patients and their caregivers, and has been shown to be efficacious in three prior clinical trials. However, as noted by our SGM community partners, the LGBT Cancer Action Council (CAC), its content has not been tailored to SGM relationships. Consequently, we propose to adapt the evidence-based FOCUS Program for SGM cancer patients and their caregivers (Aim 1). In collaboration with the LGBT CAC and guided by the transtheoretical SGM-affirmative adaptation model and ADAPT-ITT framework, we will conduct 6 focus groups with ≥24 SGM cancer patients and their ≥24 caregivers to “theater test” FOCUS and elicit qualitative feedback about adaptation. We will also elicit feedback from our panel of 5 topic experts in SGM research, and create a manualized, adapted intervention called FOCUS-SGM. We will then assess the feasibility and acceptability and explore potential outcomes of the adapted FOCUS-SGM intervention in a two-arm pilot trial (Aim 2). We will randomize 80 SGM cancer patients and their caregivers (total N≥160) to either FOCUS-SGM or a waitlist control. Assessment of patients and caregivers will occur at baseline, post-intervention, and at a 3-month follow-up (~6 months after baseline). We hypothesize that it will be feasible to recruit a sample of SGM cancer patients and caregivers through clinic, community, and online approaches; at least 80% of SGM patients and caregivers will be highly satisfied with the content and delivery of FOCUS-SGM; 75% will complete 3 or more FOCUS-SGM sessions; and 75% will complete post-intervention and 3-month follow-up assessments. We will also explore whether potential outcome measures (QOL, coping, self-efficacy to manage cancer, relationship communication, and minority stress) are responsive to the effect of FOCUS-SGM versus control. This grant represents a critical step in preparing our team to conduct a definitive trial of FOCUS-SGM, responds to community and NCI priorities, and has potential to address QOL disparities in SGM populations.