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

基于正念的压力管理计划对同种异体 HCT 护理人员的功效

• 批准号: 10096213
• 负责人: Christine Vinci
• 金额: $ 56.34万
• 依托单位: H. LEE MOFFITT CANCER CTR & RES INST
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10096213
• 关键词: Affect; Aftercare; Age; Allogenic; Anxiety; Attention; Biological Markers; Cancer Center; Cancer Intervention; Cancer Patient; Caregiver Burden; Caregiver support; Caregivers; Caring; Child Rearing; Clinic Visits; Conflict (Psychology); Continuity of Patient Care; Data; Disease; Dissemination and Implementation; Distress; Emotional; Emotions; Esthesia; Family Caregiver; Gender; Growth; Hair; Health; Hematologic Neoplasms; Hematopoietic Stem Cell Transplantation; Home; Hydrocortisone; Income; Investigation; Length; Malignant Neoplasms; Measures; Mental Depression; Mental Health; Mindfulness Training; Outcome; Participant; Patient Self-Report; Patients; Pilot Projects; Placebos; Population; Posttraumatic growth; Randomized; Reporting; Research; Role; Self Efficacy; Stress; Symptoms; Testing; Thinking; Time; Transplant Recipients; Transplantation; United States National Institutes of Health; Work; arm; attentional control; base; cancer care; cancer transplantation; caregiver interventions; caregiving; curative treatments; design; diaries; efficacy evaluation; emotion regulation; experience; follow-up; health care service utilization; hospital readmission; improved; member; mindfulness; mindfulness intervention; multidisciplinary; negative affect; novel; post-transplant; primary outcome; programs; psychosocial; residence; secondary outcome; stress management; stressor; treatment as usual

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.

项目摘要/摘要 照顾同种异性造血干细胞移植（HCT）患者是一个重大责任， 涉及到移植后至少100天的24/7全天候可用的承诺，以提供情感和 身体支持。 HCT患者的非正式家庭护理人员通常会遇到重大角色变化 与其他职责冲突（例如，工作，抚养子女）。看护人经常报告高燃烧和糟糕 心理健康，可能会对患者健康结果产生不利影响，包括增加焦虑， 抑郁症，改善患者生存。但是，一些研究表明，护理人员可能会受益 当他们获得足够的支持时，并给予增长和意义的机会时。尽管 这很少有全面和积极主动的护理人员支持计划。正念设施的能力 有目的地将注意力转移到经验上，并具有接受感（而不是试图改变或反应 对此）。正念的主动机制（例如，注意力的提高，情绪调节，分离）结合了 在HCT护理人员的独特情况下，建议通过 正念可能会传达出超越其他治疗方法中发现的益处。我们的多 纪律团队系统地开发了针对同种异体HCT的6周基于正念的干预措施 护理人员 - 重点（专注于压力下的护理人员的正念）。焦点跨越路线 患者治疗，第1节发生在移植之前，会议2-3发生在紧随其后 移植和会议4-6发生后出院。飞行员测试表明，焦点是高度可行的 对于同种异体HCT护理人员而言，可接受，可用于管理压力。大幅下降 正念，创伤后成长和心理健康症状的负面影响和增加是 从基线到治疗结束时观察到；通过1个月的随访来维持发现。这 通过随机将护理人员（n = 270）置于三个治疗条件之一的基础上，项目基于我们的试点研究： 重点，健康生活（HL）和通常的护理（UC）。这种三臂设计将使我们能够严格测试 焦点比两个HL都更有效（注意安慰剂条件匹配与时间和接触的重点） 和UC（注意控制条件）。自我报告评估将在基线，治疗结束和2-- 和治疗后6个月。生物标志物数据将通过头发皮质醇浓度和每日日记收集 将评估波动变量（例如情感，状态正念）。我们期望正念最终减少 护理人员伯恩（主要结果）通过测量的机制（例如，应力减轻）。我们期望病人 遇险和医疗保健利用将直接或间接地通过照顾者参与 重点。该提案与NIH最近呼吁开发和测试癌症的干预措施保持一致 也可以改善患者健康结果的护理人员。如果最终被证明有效，未来的研究包括 传播/实施的计划，以及向其他癌症照顾者人群扩展。