Randomized controlled trial to test feasibility of a culturally adapted meditation-based support intervention for Black patients dealing with advanced cancer

项目摘要/摘要 尽管身心干预有效地改善了癌症患者的心理和身体症状 患者，很少有研究包括黑人癌症患者。特别是，不存在针对黑人癌症的 患有晚期癌症的患者，他们很容易出现无法控制的症状，并报告说 症状严重程度和负担比他们的非西班牙裔白人(NHW)同行。在评估最终产品之前 关于心身结合的可行性和可接受性的基本方面 必须审查干预，特别是干预形式领域的干预。例如，当心智-身体 干预措施通常是在基于群体的环境中提供的，姑息治疗文献越来越多地 确定有必要将家庭照顾者纳入支持性护理干预措施，因为他们在 病人的医疗保健。这种以家庭为基础的方法可能允许患者和照顾者讨论有关关节的问题 应对癌症诊断，并解决照顾者的心理困扰，这通常会达到 临床水平。然而，这种以家庭为基础的干预可能会无意中减少获得护理的机会，如果有很多的话 黑人患者没有始终如一的护理提供者或能够/愿意共同参与的家庭成员 在干预行动中。目前尚不清楚以家庭为基础的身心练习是否可行和可接受。 在黑人晚期癌症患者中。为了解决这些严重的知识差距，拟议的 研究是为了确定实施适应文化的身心干预(冥想-- 基于支持适应的；MBS-A)作为晚期黑人患者的支持性护理策略 癌症。最初的MBS干预包括四次60分钟的会议，为期4周，包括 用情绪处理技术引导冥想(例如，正念、同情、感恩)，这有 以前主要在nhw患者-护理者二人组以及患者组设置中进行过测试。至 确定MBS-A项目的干预形式(以家庭和团体为基础)，并征求对原始项目的意见 MBS干预对于需要改编的内容，我们将首先进行形成性研究，包括 对患者和他们的主要照顾者进行定量调查和深入访谈。一旦干预行动 ，我们将进行一项随机对照试验(RCT)来检查 MBS-A干预与剂量匹配的注意控制组接受心理教育的可行性 干预。参与者将在基线(随机之前)以及6周和12周后接受评估。主要 结果包括关于总体随机对照试验设计和干预具体程序的可行性指标。 这项研究的结果将为未来的研究提供信息，在这些研究中，将测试干预的效果和机制 使用全功率黑人晚期癌症患者样本最终改善这一服务不足的地区的健康 病人群体。

PROJECT SUMMARY/ABSTRACT Although mind-body interventions effectively improve psychological and physical symptoms among cancer patients, few studies have included Black cancer patients. In particular, none exists that targets Black cancer patients dealing with advanced cancer, who are vulnerable to unmanaged symptoms and report greater symptom severity and burden than their non-Hispanic White (NHW) counterparts. Prior to evaluating definitive efficacy in this population fundamental aspects regarding the feasibility and acceptability of a mind-body intervention, particularly in the area of intervention format, must be examined. For instance, while mind-body interventions are typically delivered in group-based settings, the palliative care literature has increasingly identified the need to include family caregivers in supportive care interventions as they play a central role in patients’ healthcare. This family-based approach may allow for patient-caregiver discussions pertaining to joint coping with the cancer diagnosis and also addressing caregivers’ psychological distress, which often reach clinical levels. However, such a family-based intervention may inadvertently decrease access to care, if many Black patients do not have family members who are consistent care providers or able/willing to participate jointly in the intervention. It is currently unknown whether a family-based mind-body practice is feasible and acceptable in Black patients with advanced cancer. To address these critical knowledge gaps, the objective of the proposed research is to determine the feasibility of implementing a culturally adapted mind-body intervention (Meditation- Based Support-Adapted; MBS-A) as a supportive care strategy in Black patients diagnosed with advanced cancer. The original MBS intervention includes four 60-minute sessions delivered over 4 weeks that integrates guided meditations (e.g., mindfulness, compassion, gratitude) with emotional processing techniques, which have previously been tested in predominantly NHW patient-caregiver dyads as well as in a patient group setting. To determine the intervention format for the MBS-A program (family- vs group-based) and solicit input on the original MBS intervention regarding content that needs adaptation, we will first conduct formative research that includes quantitative surveys and in-depth interviews of patients and their primary caregivers. Once the intervention format is determined and content adapted, we will conduct a randomized controlled trial (RCT) to examine the feasibility of the MBS-A intervention vs. a dose-matched attention control arm receiving a psychoeducation intervention. Participants will be assessed at baseline (prior to randomization) and 6 and 12 weeks later. Primary outcomes include indicators of feasibility regarding the overall RCT design and intervention-specific procedures. Results of this study will inform future research in which effects and mechanisms of the intervention will be tested using fully powered samples of Black advanced cancer patients to ultimately improve health in this underserved patient population.