Effects of MBSR in Early Stage Breast Cancer Recovery

描述(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会在一生中患上这种疾病。尽管在治疗方面取得了巨大的进步，但仅在2005年，就有4万多人死于这种疾病。这些令人警醒和公认的风险是没有感染这种疾病的女性以及那些完成了新发疾病治疗的女性的主要痛苦来源。关于后者，在从结束治疗到成为乳腺癌幸存者的高度紧张的过渡期内，几乎没有临床干预措施，也没有研究测试干预措施来减少痛苦，特别是对复发的恐惧，并在此期间提高生活质量。因此，我们建议对100名最近完成手术、放疗和/或化疗的女性乳腺癌患者(0-3期)进行一项双臂随机等待名单对照研究，以了解基于正念的压力减轻(MBSR)干预的使用情况。具体地说，我们将调查：(I)MBSR是否有利地影响心理状态、生活质量、应激激素和免疫状态；以及(Ii)MBSR可能发挥作用的可能机制，特别是通过减少对乳腺癌复发的恐惧。这两个目标将在乳腺癌手术和辅助治疗完成后的关键过渡时期(此后6周至6个月)进行研究。根据Kabat Zinn和Santorelli制定的课程，MBSR干预将包括8周的课堂课程。将使用协方差模型分析来评估上述定义的结果的变化是否因随机分配(MBSR或等待名单)而不同，根据意向治疗原则。此外，由于MBSR引起的复发恐惧的改变(减少)将作为调解人进行调查。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期结果，那么这项科学将足够成熟，可以在未来大规模评估MBSR作为一种降低乳腺癌患者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.