Efficacy of a Mindfulness-Based Stress Management Program for Allogeneic HCT Caregivers

项目概要/摘要 照顾异基因造血干细胞移植（HCT）患者是一项重要的责任， 涉及承诺在移植后至少100天内24/7提供情感和 物理支持。HCT患者的非正式家庭照顾者经常经历重大的角色变化， 与其他职责冲突（例如，工作、育儿）。照顾者经常报告高负担和贫穷 心理健康，这可能对患者的健康结果产生不利影响，包括焦虑增加， 抑郁症和患者生存率下降。然而，一些研究表明， 当他们得到足够的支持，当他们有机会成长和创造意义时。尽管 因此，很少有全面和积极主动的照顾者支助方案。正念促进能力， 有目的地将注意力转移到体验上，并有一种接受感（而不是试图改变或做出反应 它）。正念的积极机制（例如，改善注意力、情绪调节、离心）结合 与HCT照顾者的独特情况，建议通过接触思想/情绪/感觉 正念可以传达超越其他治疗方法的好处。我们的多- 一个学科团队系统地开发了一种为期6周的基于正念的同种异体HCT干预 专注（Focus On mindfulness for Caregivers Under Stress）FOCUS跨越了 患者治疗，第1阶段在移植前进行，第2-3阶段在移植后立即进行 移植，以及在出院后进行的第4-6次治疗。试点测试表明，FOCUS是高度可行的 并且对于同种异体HCT护理者是可接受的，并且对于管理压力是有用的。显著下跌 负面影响和正念的增加，创伤后成长和心理健康症状， 从基线至治疗结束进行观察;结果保持至1个月随访。这 该项目建立在我们的试点研究的基础上，将护理人员（N=270）随机分配到三种治疗条件之一： 专注、健康生活（HL）和精神护理（UC）。这种三臂设计将使我们能够严格测试， FOCUS比两种HL更有效（注意安慰剂条件与FOCUS在时间和联系方面匹配） UC（Attention Control Condition）自我报告评估将在基线、治疗结束和2- 治疗后6个月。将通过头发皮质醇浓度和每日日记收集生物标志物数据 将评估波动变量（例如，影响，状态正念）。我们预计正念最终会减少 通过测量的机制（例如，减少压力）。我们期待耐心 通过护理人员参与， 专心点这项提议与NIH最近呼吁开发和测试癌症干预措施的呼吁一致 护理人员也能改善患者的健康状况。如果最终证明有效，未来的研究包括 传播/实施计划，以及扩展到其他癌症护理人群。

PROJECT SUMMARY/ABSTRACT Caring for an allogeneic hematopoietic stem cell transplant (HCT) patient is a significant responsibility, involving a commitment to be available 24/7 up to at least 100 days post-transplant to provide emotional and physical support. Informal family caregivers of HCT patients often experience significant role changes that can conflict with other responsibilities (e.g., work, child rearing). Caregivers often report high burden and poor mental health, which can have an adverse impact on patient health outcomes, including increased anxiety, depression, and decreased patient survival. However, some research suggests that caregivers may benefit when they receive adequate support and when given the opportunity for growth and meaning-making. Despite this, few comprehensive and proactive caregiver support programs exist. Mindfulness facilitates the ability to shift attention to experiences purposefully, with a sense of acceptance (as opposed to trying to change or react to it). Active mechanisms of mindfulness (e.g., improved attention, emotion regulation, decentering) combined with the unique circumstances of HCT caregivers, suggest that approaching thoughts/emotions/sensations via mindfulness may convey benefits above and beyond what is found in other treatment approaches. Our multi- disciplinary team systematically developed a 6-week mindfulness-based intervention for allogeneic HCT caregivers – FOCUS (Focusing On mindfulness for Caregivers Under Stress). FOCUS spans the course of patient treatment, with session 1 occurring prior to transplant, sessions 2-3 taking place immediately following transplant, and sessions 4-6 occurring post-discharge. Pilot testing revealed that FOCUS was highly feasible and acceptable for allogeneic HCT caregivers and useful for managing stress. Significant decreases in negative affect and increases in mindfulness, post traumatic growth, and mental health symptoms were observed from baseline to end of treatment; findings were maintained through the 1-month follow-up. This project builds on our pilot study by randomizing caregivers (N=270) to one of three treatment conditions: FOCUS, Healthy Living (HL), and Usual Care (UC). This three-arm design will allow us to rigorously test if FOCUS is more efficacious than both HL (attention placebo condition matched to FOCUS on time and contact) and UC (attention control condition). Self-report assessments will occur at baseline, end of treatment, and 2- and 6-months post-treatment. Biomarker data will be collected via hair cortisol concentrations, and daily diaries will assess fluctuating variables (e.g., affect, state mindfulness). We anticipate mindfulness to ultimately reduce caregiver burden (primary outcome) via measured mechanisms (e.g., reduced stress). We expect patient distress and healthcare utilization to be both directly and indirectly impacted via caregiver participation in FOCUS. This proposal aligns with a recent call from NIH to develop and test interventions for cancer caregivers that also improve patient health outcomes. If ultimately proven efficacious, future research includes plans for dissemination/implementation, as well as extension to other cancer caregiver populations.