Effects of MBSR in Early Stage Breast Cancer Recovery

描述（由申请人提供）：乳腺癌是美国女性中最常见的癌症-大约八分之一的女性在一生中会患上这种疾病。虽然在治疗方面取得了巨大进展，但仅在2005年就有40 000多人死于这种疾病。这些发人深省和公认的风险是未患此病的妇女和已完成新发疾病治疗的妇女的主要痛苦来源。关于后者，在从治疗到成为乳腺癌幸存者的高度紧张的过渡时期，临床干预措施几乎不存在，也没有研究测试过干预措施，以减少痛苦，特别是对复发的恐惧，并提高这段时间的生活质量。因此，我们建议在100名最近完成手术、放疗和/或化疗的女性乳腺癌患者（0-3期）中进行一项双臂随机等待列表对照研究，探讨基于正念的减压（MBSR）干预的使用。具体来说，我们将调查：（i）MBSR是否对心理状态、生活质量、应激激素和免疫状态产生有利影响;（ii）MBSR可能起作用的可能机制，特别是通过减少对乳腺癌复发的恐惧。这两个目标都将在乳腺癌手术和辅助治疗完成后的关键过渡时间（此后6周至6个月）进行研究。MBSR干预将包括8周的课程，根据Kabat Zinn和Santorelli制定的课程。根据意向治疗原则，将使用协方差分析模型评估上述定义的结局变化是否因随机分配（MBSR或等待列表）而异。此外，改变（减少）归因于MBSR复发的恐惧将被调查作为中介。如果这项R21探索性研究表明，MBSR改善了乳腺癌治疗完成后患者的近端结局，那么未来将MBSR作为一种潜在的治疗方法进行大规模评估的科学将足够成熟，以降低乳腺癌患者人群的长期发病率和死亡率。

DESCRIPTION (provided by applicant): Breast cancer is the most common cancer among women in the U.S. - about 1 in 8 women will develop the disease in their lifetime. Although tremendous strides have been made in its treatment, more than 40,000 deaths will be attributed to the disease in 2005 alone. These sobering and well-recognized risks are a major source of distress among women free from the disease, and among those who have completed treatment for new onset disease. Regarding the latter, clinical interventions are virtually absent during the highly stressful transitional period in coming off treatment to becoming a breast cancer survivor, and no studies have tested interventions to reduce distress, particularly fear of recurrence, and improve quality of life during this time. Therefore, we propose to conduct a two-armed randomized wait-list controlled study on use of a mindfulness-based stress reduction (MBSR) intervention among 100 female breast cancer patients (stages 0-3) who have recently completed treatment with surgery, radiation and/or chemotherapy. Specifically, we will investigate: (i) whether MBSR favorably influences psychological status, quality of life, stress hormones, and immune status; and (ii) possible mechanisms by which MBSR may work, in particular, through a reduction in fear of breast cancer recurrence. Both objectives will be studied at the critical transition time following completion of surgical and adjuvant therapies (6 weeks to 6 months thereafter) for breast cancer. The MBSR intervention will include 8 weeks of class sessions according to the curriculum established by Kabat Zinn and Santorelli. Analysis of covariance models will be used to assess whether change in the above-defined outcomes varies by random assignment (MBSR or wait-list), per the intention-to-treat principle. Moreover, change (reduction) in fear of recurrence attributed to MBSR will be investigated as a mediator. If this R21 exploratory study shows that MBSR improves patient proximal outcomes following completion of breast cancer treatment, the science will be mature enough for future large-scale evaluation of MBSR as a potential therapy to reduce long-term morbidity and mortality in breast cancer patient populations.