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

项目总结/摘要 虽然身心干预有效地改善了癌症患者的心理和身体症状， 然而，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药物， 患者处理晚期癌症，谁是脆弱的未管理的症状，并报告更大 症状严重程度和负担比他们的非西班牙裔白色（NHW）同行。在评估最终 在这一人群中的功效关于身心的可行性和可接受性的基本方面 必须审查干预措施，特别是干预措施的形式。例如，当身心 干预措施通常是在以小组为基础的设置交付，姑息治疗文献越来越多 确定有必要将家庭照顾者纳入支持性护理干预措施，因为他们在以下方面发挥核心作用： 患者的医疗保健。这种以家庭为基础的方法可以允许患者-护理人员讨论与关节相关的问题。 应对癌症诊断，并解决照顾者的心理困扰，这往往达到 临床水平。然而，这种以家庭为基础的干预措施可能会无意中减少获得护理的机会，如果许多人 黑人患者没有家庭成员是一致的护理提供者或能够/愿意共同参与 在干预中。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 黑人晚期癌症患者的情况为了弥补这些关键的知识差距，拟议的 研究是为了确定实施文化适应身心干预的可行性（冥想- MBS-A）作为黑人晚期乳腺癌患者的支持性护理策略 癌最初的MBS干预包括4个60分钟的会议，在4周内提供， 引导冥想（例如，正念，同情，感激）与情绪处理技术，其中有 先前已在主要为NHW的患者-护理人员二人组以及患者组环境中进行了测试。到 确定MBS-A计划的干预形式（基于家庭与基于团体），并征求对原始计划的意见。 关于MBS干预需要适应的内容，我们将首先进行形成性研究，包括 对患者及其主要照顾者进行定量调查和深入访谈。一旦介入 形式确定和内容调整后，我们将进行随机对照试验（RCT），以检查 MBS-A干预与接受心理教育的剂量匹配的注意力控制组的可行性 干预将在基线（随机化前）以及6周和12周后对受试者进行评估。初级 结果包括关于整体RCT设计和干预特定程序的可行性指标。 这项研究的结果将为未来的研究提供信息，其中将测试干预的效果和机制 使用黑人晚期癌症患者的完全动力样本，最终改善这一服务不足地区的健康状况。 患者人群。

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.