Mindfulness Meditation in Bone Marrow Transplantation

骨髓移植中的正念冥想

• 批准号: 7236140
• 负责人: SUSAN M. BAUER-WU
• 金额: $ 43.41万
• 依托单位: EMORY UNIVERSITY
• 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/7236140
• 关键词: Acute; Adverse effects; Age; Antibiotics; Antifungal Antibiotics; Antifungal Therapy; Anxiety; Anxiety Disorders; Area; Arousal; Attention; Autologous Bone Marrow Transplantation; Behavior Therapy; Behavioral; Biological; Bone Marrow; Bone Marrow Transplantation; Cancer Patient; Cardiovascular system; Care given by nurses; Caring; Catecholamines; Chronic Disease; Clinical; Condition; Control Groups; Development; Distress; Endocrine; Engraftment; Evaluation; Family; Frequencies; Friends; Goals; Health Professional; Heart; Hematologic Neoplasms; Hospitalization; Hospitals; Hour; Hydrocortisone; Immune; Infection; Intervention; Left; Length; Length of Stay; Malignant Neoplasms; Marital Status; Medical; Meditation; Modeling; Moods; Numbers; Outcome; Pain; Pain management; Patients; Personal Satisfaction; Persons; Physiological; Pilot Projects; Procedures; Psychiatric Diagnosis; Psychological Stress; Psychoneuroimmunology; Publishing; Purpose; Quality of life; Randomized; Randomized Clinical Trials; Rate; Recovery; Recruitment Activity; Relaxation; Research; Research Personnel; Risk; Sampling; Solid Neoplasm; Stem cells; Stress; Stress and Coping; Symptoms; Testing; Time; Transplantation; Urine; Visit; Visual; Visual Analogue Pain Scale; Week; Work; adult stem cell; cancer therapy; clinical research site; coping; day; design; experience; hospital readmission; improved; oncology; programs; psychologic; psychological distress; respiratory; urinary

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方法，会导致多种显着的副作用和长期住院治疗。住院期间对身体和情绪都充满挑战，而前几周和后几个月的压力也很大。有必要采取干预措施来改善 SC/ABMT 体验。 MM 已被证明对患有疾病（包括癌症）的人有帮助。然而，尚无已发表的研究调查 MM 在症状严重的住院患者中的使用情况。该研究小组的初步工作表明，MM 在住院 SC/ABMT 患者中进行是可行的，试点研究的结果表明，MM 在减轻治疗相关症状和诱导放松方面有好处。该 RCT 的主要目的是评估 MM 组与注意力对照组和常规护理对照组相比，对心理功能（感知压力和痛苦）、癌症相关身体症状以及总体质量的影响。随着时间的推移，使用寿命（从 SC/ABMT 之前到出院后最长 6 个月）。次要目标是 1) 比较神经内分泌应激标记物（24 小时尿皮质醇和儿茶酚胺水平）和免疫相关移植标记物（距骨髓植入 # 天、BMT 住院时间、# 感染、# 天）的变化三组中的抗生素/抗真菌治疗以及 BMT 后的再入院情况； 2）评估三组之间心血管觉醒（心率和呼吸频率）以及症状和情绪（视觉模拟量表）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。将从两个临床中心招募总共 280 名 SC/ABMT 患者（6 个月时的最终样本估计值=V210）。将根据临床部位和移植风险对各组进行分层。随机效应模型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三个随机组之间是否存在差异。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医疗保健专业人员产生有价值的影响，涉及对接受 SC/ABMT 等强化手术的症状严重、心理压力大的住院癌症患者的管理。