Mindfulness Meditation in Bone Marrow Transplantation

骨髓移植中的正念冥想

• 批准号: 6983785
• 负责人: SUSAN M. BAUER-WU
• 金额: $ 49.73万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-08-05 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6983785
• 关键词: alternative medicine; behavioral /social science research tag; behavioral medicine; bone marrow transplantation; cancer rehabilitation /care; clinical research; clinical trials; emotions; human subject; human therapy evaluation; meditation; neoplasm /cancer immunology; neuroendocrine system; nursing intervention; patient care management; patient oriented research; postoperative state; psychological aspect of cancer; quality of life; stress management

DESCRIPTION (provided by applicant): The overall goal of this longitudinal, randomized clinical trial (RCT) is to examine the bio-behavioral effects of mindfulness meditation (MM) in cancer patients undergoing stem cell/autologous bone marrow transplantation (SC/ABMT). SC/ABMT is a highly aggressive cancer treatment resulting in multiple significant side effects and lengthy hospitalization. The time in the hospital is both physically and emotionally challenging, while the weeks preceding and the months following are known to be quite stressful. Interventions to improve the SC/ABMT experience are warranted. MM has been shown to be helpful in persons with medical conditions, including cancer. However no published studies have investigated the use of MM in highly symptomatic, hospitalized patients. Preliminary work by this research team demonstrated that MM is feasible to carry out with hospitalized SC/ABMT patients and findings from the pilot study suggest benefits in alleviating treatment-related symptoms and inducing relaxation. The primary aim of this RCT is to evaluate the effects in a MM group, as compared to an attention control group and a usual care control group, on psychological functioning (perceived stress and distress), cancer-related physical symptoms, and overall quality of life over time (from before SC/ABMT and up to 6 months post-discharge). Secondary aims are 1) To compare changes in neuro-endocrine stress markers (24-hour urinary cortisol and catecholamine levels) and immune-related transplant markers (# days to bone marrow engraftment, length of BMT hospital stay, # infections, # days on antibiotic/antifungal therapy, and hospital readmissions post-BMT) among the three groups; 2) To evaluate short-term changes in cardiovascular arousal (heart and respiratory rates) and symptoms and mood (visual analog scales) among the three groups; and 3) To explore associations among psychological, physical (symptoms), neuro-endocrine, immune-related, and patient background variables. A total of 280 SC/ABMT patients will be recruited from two clinical sites (estimate of final sample at 6 months =V210). Groups will be stratified by clinical site and transplant risk. Random effects modeling will model the primary outcomes over time and test whether the mean levels of these outcomes differ among the three randomized groups. If statistical evidence of differences is found, then the effects at each time point will be estimated. These findings could have valuable implications for oncology healthcare professionals related to the management of highly symptomatic and psychologically stressed, hospitalized cancer patients undergoing intensive procedures such as SC/ABMT.

描述（由申请人提供）：这项纵向，随机临床试验（RCT）的总体目标是检查正念冥想（MM）对正在接受干细胞/自体骨髓移植（SC/ABMT）的癌症患者的生物行为影响。 。 SC/ABMT是一种高度侵略性的癌症治疗，导致多种显着的副作用和冗长的住院治疗。医院的时间在身体和情感上都充满挑战，而在之前的几周和后面的几个月都非常压力。有必要采取改善SC/ABMT体验的干预措施。 MM已被证明对包括癌症在内的医疗状况的患者有帮助。但是，没有发表的研究研究了在高度症状的住院患者中使用MM。该研究小组的初步工作表明，MM可行，可以与住院的SC/ABMT患者进行，而试点研究的发现表明，有益于减轻治疗相关症状并诱发放松的好处。与注意力控制组和通常的护理对照组相比，该RCT的主要目的是评估MM组的效果，对心理功能（感知到的压力和困扰），与癌症相关的身体症状以及整体质量随着时间的流逝（从SC/ABMT之前和入院后六个月）的生活。次要目的是1）比较神经内分泌压力标记（24小时尿皮质醇和儿茶酚胺水平）和免疫相关的移植标记（骨髓植入的＃天数，BMT医院的长度，＃感染，＃天数，＃三组抗生素/抗真菌疗法和BMT后的医院再入院； 2）评估三组中心血管唤醒（心脏和呼吸率）以及症状和情绪（视觉模拟尺度）的短期变化； 3）探索心理，身体（症状），神经内分泌，免疫相关和患者背景变量之间的关联。总共将从两个临床部位招募280名SC/ABMT患者（6个月= V210的最终样本估算）。组将按临床部位和移植风险进行分层。随机效应建模将随着时间的推移对主要结果进行建模，并测试这些结果的平均水平在这三个随机组之间是否有所不同。如果发现差异的统计证据，则将估算每个时间点的影响。这些发现可能对与严重症状和心理压力，住院的癌症患者（例如SC/ABMT）的治疗有关，对肿瘤学医疗保健专业人员具有宝贵的影响。