Effects of MBSR in Early Stage Breast Cancer Recovery

MBSR 对早期乳腺癌康复的影响

• 批准号: 7028534
• 负责人: Cecile A Lengacher
• 金额: $ 16.53万
• 依托单位: UNIVERSITY OF SOUTH FLORIDA
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7028534
• 关键词: behavioral /social science research tag; breast neoplasms; cancer rehabilitation /care; clinical research; fear; female; human subject; human therapy evaluation; longitudinal human study; medical rehabilitation related tag; mental health education; patient oriented research; psychological aspect of cancer; psychological tests; quality of life; stress management

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.

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发展出这种疾病。尽管在治疗方面已经取得了长足的进步，但仅在2005年，就会归因于该疾病40,000多人。这些清醒且公认的风险是没有疾病的妇女的主要困扰来源，而在那些已经完成了新发作疾病治疗的妇女中。关于后者，在高度压力的过渡期间，几乎没有临床干预措施成为乳腺癌幸存者，并且在此期间，没有研究过研究干预措施以减少困扰，尤其是对复发和改善生活质量的恐惧。因此，我们建议对100名女性乳腺癌患者（第0-3阶段）对使用基于正念的压力减轻（MBSR）干预的两臂随机等待名单对照研究，这些研究最近完成了手术，放射和/或化学疗法的治疗。具体来说，我们将调查：（i）MBSR是否有利地影响心理状况，生活质量，压力激素和免疫地位； （ii）MBSR尤其是通过害怕乳腺癌复发的可能性来起作用的可能机制。在完成手术和辅助疗法（此后6周到6个月）后，将在关键的过渡时间研究这两个目标。根据Kabat Zinn和Santorelli建立的课程，MBSR干预将包括8周的课程课程。根据意图对处理原则，将使用协方差模型的分析来评估上述结果的变化是否因随机分配（MBSR或Wait-List）而有所不同。此外，由于担心归因于MBSR的复发而变化（减少）将作为调解人进行研究。如果这项R21探索性研究表明，MBSR改善了乳腺癌治疗完成后的患者近端结局，那么该科学将足够成熟，以便将来对MBSR进行大规模评估，作为降低乳腺癌患者人群中长期发病率和死亡率的潜在疗法。