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将在其一生中患上这种疾病。尽管在治疗该病方面取得了巨大进展，但仅2005年就将有4万多人死于该病。这些令人清醒的、公认的风险是未患该病的妇女和已完成新发疾病治疗的妇女痛苦的主要来源。对于后者，在结束治疗成为乳腺癌幸存者的高度压力过渡时期，临床干预措施实际上是缺乏的，并且没有研究测试干预措施来减少痛苦，特别是对复发的恐惧，并提高这段时间的生活质量。因此，我们建议对100名最近完成手术、放疗和/或化疗治疗的女性乳腺癌患者（0-3期）进行一项基于正念减压（MBSR）干预的双臂随机等待名单对照研究。具体而言，我们将调查：(i)正念减压是否对心理状态、生活质量、应激激素和免疫状态有积极影响；（ii）正念减压疗法的可能作用机制，特别是通过减少对乳腺癌复发的恐惧。这两个目标将在乳腺癌手术和辅助治疗完成后的关键过渡时间（6周至6个月）进行研究。正念减压干预将包括8周的课堂课程，根据Kabat Zinn和Santorelli建立的课程。协方差模型分析将用于评估上述结果的变化是否因随机分配（MBSR或等候名单）而异，根据意向治疗原则。此外，正念减压引起的复发恐惧的改变（减少）将作为中介进行研究。如果这项R21探索性研究表明，正念减压疗法改善了乳腺癌治疗完成后患者的近端预后，那么该科学将足够成熟，可以在未来大规模评估正念减压疗法作为降低乳腺癌患者群体长期发病率和死亡率的潜在疗法。

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.