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.

项目总结/文摘