Mindfulness Meditation in Bone Marrow Transplantation

描述(申请人提供)：这项纵向随机临床试验(RCT)的总体目标是检测正念冥想(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方法，会产生多种严重的副作用和长时间的住院治疗。在医院的时间既是身体上的挑战，也是精神上的挑战，而之前的几周和接下来的几个月都是非常有压力的。改善SC/ABMT体验的干预措施是必要的。MM已被证明对患有包括癌症在内的疾病的人有帮助。然而，没有发表的研究调查MM在高症状住院患者中的使用情况。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，试点研究的结果表明，MM在缓解治疗相关症状和诱导放松方面有好处。这项随机对照试验的主要目的是评估MM组与注意力控制组和常规护理控制组相比，随着时间的推移(从SC/ABMT前到出院后长达6个月)对心理功能(感觉到的压力和痛苦)、癌症相关的身体症状和总体生活质量的影响。次要目标是：1)比较三组间神经内分泌应激标志物(24小时尿皮质醇和儿茶酚胺水平)和免疫相关移植标志物(骨髓移植前#天、骨髓移植住院时间、感染#天、抗生素/抗真菌治疗#天、骨髓移植后再住院#天)的变化；2)评估三组间心血管唤醒(心率和呼吸率)以及症状和情绪(视觉模拟评分)的短期变化；3)探索心理、生理(症状)、神经内分泌、免疫相关和患者背景变量之间的关系。总共280名SC/ABMT患者将从两个临床地点招募(6个月的最终样本估计=V210)。分组将根据临床地点和移植风险进行分层。随机效应建模将模拟随时间推移的主要结果，并测试这些结果的平均水平在三个随机化组中是否不同。如果发现差异的统计证据，则将估计每个时间点的影响。这些发现可能对肿瘤学保健专业人员有价值的启示，这些专业人员与接受SC/ABMT等强化手术的高度症状和心理压力的住院癌症患者的管理相关。

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.