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: 10604286
• 负责人: Christine Vinci
• 金额: $ 57.94万
• 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/10604286
• 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; Measures; Mental Depression; Mental Health; Mindfulness Training; Outcome; Participant; Patient Care; Patient Self-Report; Patients; Pilot Projects; Placebos; Population; Posttraumatic growth; Randomized; Reaction; Reporting; Research; Role; Self Efficacy; Stress; Symptoms; Testing; Thinking; Time; Transplant Recipients; Transplantation; United States National Institutes of Health; Work; acceptability and feasibility; arm; attentional control; cancer care; 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; pilot test; post-transplant; primary outcome; programs; psychosocial; residence; secondary outcome; stress management; stress reduction; 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.

项目概要/摘要 照顾同种异体造血干细胞移植 (HCT) 患者是一项重大责任， 涉及承诺在移植后至少 100 天 24/7 提供情感和帮助 物理支持。 HCT 患者的非正式家庭护理人员经常会经历重大的角色变化，这可能会导致 与其他责任（例如工作、抚养孩子）发生冲突。护理人员经常报告负担重且贫困 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， 抑郁症，并降低患者的生存率。然而，一些研究表明，护理人员可能会受益 当他们得到足够的支持并获得成长和创造意义的机会时。尽管 因此，全面且主动的护理人员支持计划很少存在。正念可以促进以下能力： 有目的地将注意力转移到经历上，带着一种接受感（而不是试图改变或做出反应） 到它）。正念的主动机制（例如，提高注意力、情绪调节、去中心化）相结合 鉴于 HCT 护理人员的独特情况，建议通过以下方式处理想法/情绪/感觉： 正念可以带来超越其他治疗方法的益处。我们的多 学科团队系统地制定了为期 6 周的基于正念的同种异体 HCT 干预措施 护理人员 – 焦点（关注压力下护理人员的正念）。焦点贯穿整个过程 患者治疗，第 1 疗程在移植前进行，第 2-3 疗程在移植后立即进行 移植，以及出院后进行的第 4-6 次治疗。试点测试表明 FOCUS 高度可行 对于同种异体 HCT 护理人员来说是可以接受的，并且对于管理压力很有用。显着减少 负面影响和正念、创伤后成长和心理健康症状的增加 从基线到治疗结束进行观察；结果在 1 个月的随访中得以维持。这 该项目以我们的试点研究为基础，将护理人员 (N=270) 随机分配到以下三种治疗条件之一： 焦点、健康生活 (HL) 和日常护理 (UC)。这种三臂设计将使我们能够严格测试是否 FOCUS 比 HL 更有效（注意安慰剂条件与 FOCUS 在时间和接触方面相匹配） 和 UC（注意力控制条件）。自我报告评估将在基线、治疗结束和 2- 以及治疗后 6 个月。将通过头发皮质醇浓度和每日日记收集生物标记数据 将评估波动变量（例如，情感、状态正念）。我们预计正念最终会减少 通过测量机制（例如减轻压力）减轻照顾者负担（主要结果）。我们期待患者 通过护理人员的参与，痛苦和医疗保健利用将受到直接和间接的影响 重点。该提案与 NIH 最近呼吁开发和测试癌症干预措施相一致 护理人员也可以改善患者的健康状况。如果最终被证明有效，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员群体的计划。