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

随机对照试验，测试针对晚期癌症黑人患者进行基于文化的冥想支持干预的可行性

• 批准号: 10648212
• 负责人: Dalnim Cho
• 金额: $ 24.3万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2025-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10648212
• 关键词: Address; Adult; Advanced Malignant Neoplasm; Area; Benchmarking; Black Populations; Black race; Cancer Control; Cancer Patient; Cancer Survivor; Caregivers; Clinical; Cohort Studies; Compassion; Control Groups; Data; Diagnosis; Disparity; Dose; Emotional; Exclusion; Faith; Family; Family Caregiver; Family member; Future; Health; Health Services Accessibility; Healthcare; Intervention; Intervention Studies; Interview; Joints; Knowledge; Literature; Malignant Neoplasms; Meditation; Mind-Body Intervention; Not Hispanic or Latino; Palliative Care; Participant; Patient Care; Patients; Play; Population; Procedures; Protocols documentation; Quality of life; Randomized; Randomized, Controlled Trials; Reduce health disparities; Reporting; Research; Role; Sampling; Severities; Solid; Supportive care; Surveys; Survival Rate; Symptoms; Techniques; Testing; United States National Institutes of Health; Videoconferencing; acceptability and feasibility; arm; attentional control; black patient; cancer diagnosis; care providers; coping; effective intervention; feasibility testing; gratitude; improved; interest; intervention delivery; meetings; mind/body; mindfulness; patient population; physical symptom; pilot test; population based; primary caregiver; primary outcome; programs; psychoeducational intervention; psychological distress; psychological symptom; recruit; retention rate; success; treatment arm; trial design

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.

项目摘要/摘要 尽管心身干预有效地改善了癌症的心理和身体症状 患者，很少有研究包括黑色癌症患者。特别是，没有一种针对黑癌的 处理晚期癌症的患者，他们容易出现不受管理的症状并报告更大 症状的严重程度和燃烧比非西班牙裔白人（NHW）对应物。在评估权威之前 在这个人群的基本方面，有关思维体的可行性和可接受性的疗效 必须检查干预措施，特别是在干预格式领域。例如，心身 干预措施通常在基于小组的设置中提供，姑息治疗文献有所增加 确定需要将家庭照顾者纳入支持性护理干预措施，因为他们在 患者的医疗保健。这种基于家庭的方法可能允许与关节有关的患者护理人员讨论 应对癌症诊断，并解决护理人员的心理困扰，这通常会达到 临床水平。但是，这样的基于家庭的干预可能会无意间减少获得护理的机会 黑人患者没有始终如一的护理提供者或愿意/愿意共同参加的家庭成员 在干预中。目前尚不清楚基于家庭的思维体练习是否可行且可接受 黑人晚期癌症患者。为了解决这些关键的知识差距，提议的目的 研究是为了确定实施文化适应的思维体型干预的可行性（冥想 - 基于支持的支持； MBS-A）作为诊断为晚期的黑人患者的支持性护理策略 癌症。最初的MBS干预包括四个60分钟的60分钟课程 具有情感处理技巧的指导性冥想（例如正念，同情，感激之情） 以前在NHW的患者护理人员的二元组以及患者组中进行了测试。到 确定MBS-A计划（基于家庭与组）的干预格式，并征集对原始的输入 MBS干预有关需要适应的内容的干预，我们将首先进行包括 对患者及其主要护理人员的定量调查和深入的访谈。一旦干预 确定格式并适应内容，我们将进行一项随机对照试验（RCT），以检查 MBS-A干预的可行性与接受心理教育的剂量匹配注意力控制臂 干涉。参与者将在基线（随机化之前）和6周后进行评估。基本的 结果包括有关整体RCT设计和特定于干预程序的可行性的指标。 这项研究的结果将为未来的研究提供信息，从而测试干预的效果和机制 使用完全动力的黑色晚期癌症患者样本，最终改善服务不足的人的健康状况 患者人数。