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是一种高度侵袭性的癌症治疗，导致多种显著的副作用和长期住院。在医院的时间是身体和情感上的挑战，而之前的几周和之后的几个月是众所周知的压力很大。有必要采取干预措施改善SC/ABMT的经验。MM已被证明对患有医学疾病（包括癌症）的人有帮助。然而，尚未发表研究调查MM在高度症状性住院患者中的使用。该研究小组的初步工作表明，MM对住院的SC/ABMT患者是可行的，初步研究的结果表明，MM在缓解治疗相关症状和诱导放松方面具有益处。本RCT的主要目的是评价MM组与注意力控制组和常规护理对照组相比，对心理功能（感知压力和痛苦）、癌症相关躯体症状和总体生活质量随时间推移的影响（从SC/ABMT前至出院后6个月）。次要目的是1）比较神经内分泌应激标志物的变化（24小时尿皮质醇和儿茶酚胺水平）和免疫相关移植标志物三组之间（骨髓移植前#天、BMT住院时间、#感染、#抗生素/抗真菌治疗天数以及BMT后再次入院）; 2）评估心血管唤醒的短期变化（心率和呼吸率）和症状及情绪（视觉模拟量表）;探讨心理、生理（症状）、神经内分泌、免疫相关和患者背景变量之间的关联。将从两个临床研究中心共招募280例SC/ABMT患者（6个月时最终样本的估计值=V210）。将按临床试验机构和移植风险对各组进行分层。随机效应建模将对主要结局随时间的变化进行建模，并检验这些结局的平均水平在三个随机分组之间是否存在差异。如果发现差异的统计学证据，则将估计每个时间点的效应。这些发现可能对肿瘤学医疗保健专业人员具有重要意义，这些专业人员与接受SC/ABMT等强化程序的高度症状和心理压力的住院癌症患者的管理有关。