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

项目摘要 本项目的目标是调整经临床验证的FOCUS干预，并测试其可行性， 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，包括少数民族压力， 或者生活在一个被污名化的SGM身份中所产生的慢性压力。此外，SGM的护理人员 在主要为异性恋/顺性恋服务的医疗保健系统中， （H/C）患者; H/C患者的护理人员的资源往往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;这些不同的SGM照顾者可能是 在癌症护理环境中受到少数民族压力的影响。需要心理教育干预来解决这些问题 差异，共同提高SGM癌症患者及其护理人员的生活质量。FOCUS干预 使用心理教育和解决问题来改善癌症患者的生活质量，应对和自我效能 和他们的照顾者，并已被证明是有效的，在三个先前的临床试验。然而，正如我们注意到的那样， SGM社区合作伙伴，LGBT癌症行动理事会（CAC），其内容尚未针对SGM量身定制 关系。因此，我们建议将循证的FOCUS计划用于SGM癌症 患者及其护理人员（目标1）。与LGBT CAC合作，并在跨理论的指导下， SGM-肯定适应模型和ADAPT-ITT框架，我们将进行6个焦点组，SGM ≥24 癌症患者及其≥24名护理人员进行“剧场测试”FOCUS，并获得有关适应的定性反馈。 我们还将从SGM研究中的5位主题专家小组中征求反馈意见，并创建一个手动的，适应性的 干预称为FOSS-SGM。然后，我们将评估可行性和可接受性，并探讨潜力 在一项两组试点试验中，调整后的FORGANI-SGM干预的结果（目标2）。我们将随机抽取80名 SGM癌症患者及其护理人员（总N≥160）与FORES-SGM或候补对照组。评估 的患者和护理人员将在基线、干预后和3个月随访（约6个月）时发生 基线后）。我们假设招募SGM癌症患者和护理人员的样本是可行的 通过诊所，社区和在线方法;至少80%的SGM患者和护理人员将高度重视 对FOOKS-SGM的内容和交付感到满意; 75%的人将完成3个或更多FOOKS-SGM课程; 75%将完成干预后和3个月随访评估。我们还将探讨 潜在的结果指标（QOL，应对，自我效能感，以管理癌症，关系沟通， 少数应激）对FOX-SGM与对照的作用有反应。这笔赠款代表了关键的一步 在准备我们的团队进行一个明确的试验FORES-SGM，响应社区和NCI的优先事项， 并有可能解决SGM人群的生活质量差异。

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.