MBSR Symptom Cluster Trial for Breast Cancer Survivors

描述(申请人提供)：乳腺癌是女性中最常见的癌症。治疗完成后，乳腺癌幸存者经常会出现残留症状，包括疼痛、疲劳、睡眠障碍、焦虑、抑郁和对复发的恐惧。这种广泛的治疗后症状，以及可能伴随的与应激相关的细胞因子反应，可能是组合(簇)发生的。考虑到这一受影响的患者群体的规模，对这一未被充分研究的癌症幸存者进行有效的干预是至关重要的。根据RFA PA-07-074的前2份申请和PA-07-070的第3份申请，本申请的主要目标是在乳腺癌幸存者中严格评估基于正念的压力减轻(MBSR)乳腺癌(BC)计划的疗效。具体地说，我们的目标是确定：(1)MBSR(BC)计划在多大程度上改善了治疗完成后的患者结果；(2)MBSR(BC)计划有效的方式(机制)；以及(3)特定的患者亚群是否从MBSR(BC)计划中获得最大好处。为了实现这些目标，我们将对330名患有0、I、II和III期乳腺癌的妇女进行随机临床试验，她们已经接受过肿块切除术和/或乳房切除术，并且在辅助放疗和/或化疗完成治疗的两年内。这一时期与正规医疗停止，但残留症状仍然存在的关键过渡时期相对应。患者将被随机分配到MBSR(BC)计划或稍后提供MBSR(BC)计划的等待名单上的普通护理方案。患者评估将在基线、6周和12周进行，将包括心理症状(抑郁、焦虑、感知到的压力)、身体症状(疼痛、疲劳、睡眠障碍)、生活质量、生物应激标记物(促炎免疫细胞因子、细胞黏附分子、淋巴细胞亚群)和应激相关激素(皮质醇、儿茶酚胺)的测量。被评估的MBSR(BC)计划是一个临床计划，提供系统的训练，通过自我调节对压力的唤醒来促进压力减轻。我们小组已经为乳腺癌幸存者修改了这一计划，并展示了其缓解症状的初步证据。展望未来，我们将正式测试：(1)MBSR(BC)计划是否导致心理症状、身体症状、生活质量和生物应激标记的初期(6周)和短期(12周)改善比平时护理更大；(2)MBSR(BC)计划的患者报告说，注意力有更大的提高，对复发的恐惧有更大的减少，这反过来又减少了心理和身体症状和应激相关激素，以及提高了生活质量；(3)MBSR(BC)计划在存在高焦虑、高压力、低乐观、生活质量差和特定症状特征(即高度痛苦的患者)的患者中效果最好。

DESCRIPTION (provided by applicant): Breast cancer is the most prevalent form of cancer among women. After treatment completion, breast cancer survivors frequently experience residual symptoms including pain, fatigue, sleep dysfunction, anxiety, depression, and fear of recurrence. This wide range of post-treatment symptoms, and possibly concomitant stress-related cytokine responses, may occur in combination (clusters). Effective interventions for this understudied group of cancer survivors are paramount given the size of this affected patient population. The primary goal of this application in response to RFA PA-07-074 for the first 2 submissions, and PA- 07-070 for this 3rd submission is to rigorously evaluate the efficacy of the Mindfulness Based Stress Reduction (MBSR) Breast Cancer (BC) program among breast cancer survivors. Specifically, we aim to determine: (1) the extent to which the MBSR (BC) program improves patient outcomes after treatment completion; (2) the manner (mechanisms) by which the MBSR (BC) program is effective; and (3) if particular subgroups of patients derive the most benefit from the MBSR (BC) program. To achieve these aims, we will conduct a randomized clinical trial of 330 women with Stage 0, I, II, and III breast cancer who have undergone lumpectomy and/or mastectomy, and are within 2 years of completion of treatment with adjuvant radiation and/or chemotherapy. This period corresponds to the critical transition time when formal medical treatment has ceased, yet residual symptoms remain. Patients will be randomly assigned in equal probability to the MBSR (BC) program or a waitlisted usual care regimen that is later offered the MBSR (BC) program. Patient assessments will be made at baseline, 6 weeks, and 12 weeks, and will include measures of psychological symptoms (depression, anxiety, perceived stress), physical symptoms (pain, fatigue, sleep dysfunction), quality of life, biological stress markers (pro-inflammatory immune cytokines, cellular adhesion molecules, lymphocyte subsets) and stress-related hormones (cortisol, catecholamines). The MBSR (BC) program to be evaluated is a clinical program that provides systematic training to promote stress reduction by self-regulating arousal to stress. Our group has modified this program for breast cancer survivors and shown preliminary evidence of its efficacy in reducing symptoms. Going forward, we will formally test whether: (1) the MBSR (BC) program results in greater initial (6 week) and short-term sustained (12 week) improvements in psychological symptoms, physical symptoms, quality of life, and biological stress markers compared to Usual Care; (2) patients in the MBSR (BC) program report greater increases in mindfulness and larger reductions in fear of recurrence which, it turn, reduce psychological and physical symptoms and stress-related hormones, as well as improve quality of life; and (3) the efficacy of the MBSR (BC) program is greatest among patients who present with high anxiety, high perceived stress, low optimism, poor quality of life, and specific symptom profiles (i.e. highly distressed patients).