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

针对性和性别少数 (SGM) 癌症患者和护理人员调整 F​​OCUS 计划

• 批准号: 10730265
• 负责人: Theresa Ann Hastert
• 金额: $ 29.42万
• 依托单位: UNIVERSITY OF ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-03 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10730265
• 关键词: Address; Affect; Cancer Control; Cancer Control Research; Cancer Patient; Caregivers; Chronic stress; Clinic; Clinical Trials; Code; Collaborations; Communication; Communities; Community Outreach; Consultations; Diagnosis; Disparity; Effectiveness; Emotional; Face; Family; Feedback; Focus Groups; Friends; Future; Goals; Grant; Health; Healthcare Systems; Heterosexuals; Improve Access; Intervention; Lesbian Gay Bisexual Transgender; Lesbian Gay Bisexual Transgender Queer; Link; Malignant Neoplasms; Manuals; Minority Health Research; Modeling; Monitor; Names; Outcome; Outcome Measure; Patients; Persons; Population; Problem Solving; Psychosocial Assessment and Care; Quality of life; Randomized; Recurrent Malignant Neoplasm; Resources; Sampling; Self Efficacy; Services; Sexual and Gender Minorities; Stigmatization; System; Testing; Transcript; Treatment Efficacy; Uncertainty; Waiting Lists; acceptability and feasibility; arm; cancer care; cancer recurrence; caregiving; cisgender; community engaged research; coping; design; evidence base; experience; follow up assessment; follow-up; gender minority community; gender minority group; improved; informal caregiver; member; minority patient; minority stress; mortality; phenomenological models; pilot trial; post intervention; programs; psychoeducation; psychoeducational; psychoeducational intervention; psychological distress; psychosocial; randomized trial; recruit; response; sexual relationship; symptom management; theories; trial planning

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.

项目摘要 该项目的目标是采用经过实证验证的 FOCUS 干预措施并测试其可行性和 性少数和性别少数 (SGM) 癌症患者及其护理人员的可接受性。 患者面临未解决的挑战，对他们的生活质量（QOL）产生不利影响，包括少数族裔压力， 或因生活在 SGM 的污名化身份中而产生的慢性压力。 此外，SGM 的照顾者。 主要为异性恋/顺性别服务的医疗保健系统通常不承认患者 (H/C) 患者；为 H/C 患者的护理人员提供的资源往往无法满足他们的需求； 更有可能依赖 SGM 朋友或前伴侣作为照顾者，而这些不同的 SGM 照顾者可能是 需要心理教育干预措施来解决这些问题。 差异并共同改善 SGM 癌症患者及其护理人员的生活质量。 利用心理教育和问题解决来提高癌症患者的生活质量、应对能力和自我效能 及其护理人员，并且在之前的三项临床试验中已被证明是有效的。然而，正如我们所指出的。 SGM社区合作伙伴LGBT癌症行动委员会（CAC），其内容并未针对SGM量身定制 经过测试的关系，我们建议针对 SGM 癌症调整基于证据的 FOCUS 计划 患者及其护理人员（目标 1）与 LGBT CAC 合作并以跨理论为指导。 SGM-肯定式适应模型和ADAPT-ITT框架，我们将进行6个焦点小组≥24个SGM 癌症患者及其 ≥24 名护理人员进行“戏剧测试”焦点并引出有关适应的定性反馈。 我们还将征求由 SGM 研究领域的 5 名主题专家组成的小组的反馈，并创建一个手动的、适应性强的 然后我们将评估可行性和可接受性并探索潜力。 改编后的 FOCUS-SGM 干预在双臂试点试验中的结果（目标 2） 我们将随机分配 80 名患者。 SGM 癌症患者及其护理人员（总数≥160）接受 FOCUS-SGM 或候补名单评估。 患者和护理人员的评估将在基线、干预后和 3 个月随访时（约 6 个月 我们追求招募 SGM 癌症患者和护理人员样本是可行的。 通过诊所、社区和在线方式，至少 80% 的 SGM 患者和护理人员将高度重视 对FOCUS-SGM的内容和交付感到满意；75%将完成3次或以上FOCUS-SGM会议； 75%将完成干预后和3个月的随访评估，我们还将探讨是否。 潜在的结果指标（生活质量、应对方式、管理癌症的自我效能、关系沟通和 少数族裔压力）对 FOCUS-SGM 与控制的影响做出反应。这项资助代表了关键的一步。 准备我们的团队进行 FOCUS-SGM 的最终试验，响应社区和 NCI 的优先事项， 并有潜力解决 SGM 人群的生活质量差异。