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

项目摘要/摘要 照顾异基因造血干细胞移植(HCT)患者是一项重大的责任， 包括承诺在移植后至少100天内全天候提供情感和 身体上的支持。HCT患者的非正式家庭照顾者通常会经历重大的角色变化，这可能 与其他职责(例如，工作、育儿)发生冲突。照顾者经常报告负担重且贫穷 心理健康，这可能对患者的健康结果产生不利影响，包括增加焦虑， 抑郁，并降低了患者的存活率。然而，一些研究表明，照顾者可能会受益 当他们得到足够的支持，当他们获得成长和创造意义的机会时。尽管 这一点，几乎没有全面和积极的照顾者支持计划。正念有助于提高 有目的地将注意力转移到体验上，带着一种接受感(而不是试图改变或反应 到它)。正念的主动机制(例如，改善注意力、情绪调节、分心)结合在一起 根据HCT照顾者的独特情况，建议通过以下方式接近思想/情绪/感觉 正念可能传递出比其他治疗方法更多的好处。我们的多- 纪律小组系统地开发了一项为期6周的基于正念的异基因红细胞移植干预 照顾者-专注(关注压力下照顾者的正念)。焦点横跨整个过程 患者治疗，第一阶段在移植前进行，第二阶段至第三阶段紧随移植后进行 移植，以及出院后发生的第4-6次会议。初步测试表明，Focus是高度可行的 对于异基因HCT照顾者来说是可以接受的，并且对管理压力很有用。显著减少了 负性情绪和正念、创伤后成长和心理健康症状的增加 从基线观察到治疗结束；通过1个月的随访维持结果。这 该项目以我们的初步研究为基础，将照顾者(N=270)随机分配到三种治疗条件之一： 焦点、健康生活(HL)和日常护理(UC)。这种三臂设计将允许我们严格测试 Focus比两种HL都更有效(注意力安慰剂条件与关注时间和接触相匹配) 和UC(注意控制条件)。自我报告评估将在基线、治疗结束和2- 治疗后6个月。生物标记物数据将通过头发皮质醇浓度和日常日记收集 将评估波动变量(例如，情绪、状态正念)。我们预计正念最终会减少 照顾者的负担(主要结果)通过衡量的机制(例如，减轻压力)。我们希望有耐心 通过照顾者参与将直接和间接地影响痛苦和医疗保健利用 全神贯注。这一建议与美国国立卫生研究院最近提出的开发和测试癌症干预措施的呼吁相一致 护理者也能改善患者的健康状况。如果最终被证明是有效的，未来的研究包括 传播/实施计划，以及推广到其他癌症护理人员群体。

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.