Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida, United States of America.
Department of Psychology, University of South Florida, Tampa, Florida, United States of America.
PLoS One. 2022 Apr 1;17(4):e0266316. doi: 10.1371/journal.pone.0266316. eCollection 2022.
Caregivers of allogeneic hematopoietic stem cell transplant (HCT) cancer patients experience high caregiver burden and carry a significant amount of responsibility. Mindfulness has the potential to lessen caregiver burden by aiding in stress management. To date, no studies have examined the efficacy of mindfulness in reducing caregiver burden in this population. Based on our pilot study demonstrating initial feasibility and acceptability of FOCUS (Focusing On mindfulness for Caregivers Under Stress), this 3-arm randomized controlled trial aims to examine the efficacy of a 6-week mindfulness-based stress management program for allogeneic HCT caregivers. Hypotheses include that the FOCUS condition will have lower post-treatment caregiver burden and that patients of these caregivers will have better patient health outcomes compared to other treatment conditions.
Eligible caregivers will be randomly assigned to one of three treatment conditions: FOCUS, Healthy Living (HL; active control), and Enhanced Care (EC; usual care). Caregivers in FOCUS and HL will participate in 6-week weekly individual treatment sessions and will be sent brief daily momentary interventions/messages. Caregivers in all conditions will complete daily diaries over the course of treatment. Patients of enrolled caregivers will be enrolled for assessments only. Participants will complete assessments at baseline, end of treatment, 2- and 6-months post-treatment. Biomarker data will be collected via hair cortisol concentrations from caregivers at baseline and 6 months post-treatment.
Recruitment is ongoing.
The data collected from this study will provide evidence on the efficacy of mindfulness in alleviating HCT caregiver stress and impacting patient health outcomes.
The current study is registered in clinicaltrials.gov (NCT05078229); see https://clinicaltrials.gov/ct2/show/NCT05078229?term=christine+vinci&draw=2&rank=1.
异基因造血干细胞移植（HCT）癌症患者的护理人员经历着较高的护理人员负担，并承担着大量的责任。正念有减轻护理人员负担的潜力，可帮助管理压力。迄今为止，尚无研究检查正念在减轻该人群护理人员负担方面的功效。基于我们的初步研究，该研究证明了 FOCUS（关注压力下的护理人员）的初步可行性和可接受性，本 3 臂随机对照试验旨在研究为期 6 周的正念应激管理方案对异基因 HCT 护理人员的疗效。假设包括 FOCUS 条件下治疗后护理人员的负担会降低，并且这些护理人员的患者的患者健康结果会优于其他治疗条件。
符合条件的护理人员将被随机分配到以下三种治疗条件之一：FOCUS、健康生活（HL；积极对照）和强化护理（EC；常规护理）。FOCUS 和 HL 的护理人员将参加为期 6 周的每周一次的个体治疗会议，并将收到简短的每日即时干预/信息。所有条件下的护理人员将在治疗期间完成每日日记。入组护理人员的患者将仅进行评估。参与者将在基线、治疗结束时、治疗后 2 个月和 6 个月进行评估。通过基线和治疗后 6 个月护理人员的头发皮质醇浓度收集生物标志物数据。
正在进行招募。
从这项研究中收集的数据将提供有关正念减轻 HCT 护理人员压力和影响患者健康结果的功效的证据。
目前的研究在 clinicaltrials.gov 上注册（NCT05078229）；请访问 https://clinicaltrials.gov/ct2/show/NCT05078229?term=christine+vinci&draw=2&rank=1。
