Research and Development Centre, Skaraborg Hospital, Skövde, Sweden.
BMC Complement Altern Med. 2013 Oct 2;13:248. doi: 10.1186/1472-6882-13-248.
The stress of a breast cancer diagnosis and its treatment can produce a variety of psychosocial sequelae including impaired immune responses. Mindfulness Based Stress Reduction (MBSR) is a structured complementary program that incorporates meditation, yoga and mind-body exercises. Despite promising empirical evidence for the efficacy of MBSR, there is a need for randomized controlled trials (RCT). There is also a need for RCTs investigating the efficacy of psychosocial interventions on mood disorder and immune response in women with breast cancer. Therefore, the overall aim is to determine the efficacy of a Mindfulness Based Stress Reduction (MBSR) intervention on well-being and immune response in women with breast cancer.
In this RCT, patients diagnosed with breast cancer, will consecutively be recruited to participate. Participants will be randomized into one of three groups: MBSR Intervention I (weekly group sessions + self-instructing program), MBSR Intervention II (self-instructing program), and Controls (non-MBSR). Data will be collected before start of intervention, and 3, 6, and 12 months and thereafter yearly up to 5 years. This study may contribute to evidence-based knowledge concerning the efficacy of MBSR to support patient empowerment to regain health in breast cancer disease.
The present study may contribute to evidence-based knowledge concerning the efficacy of mindfulness training to support patient empowerment to regain health in a breast cancer disease. If MBSR is effective for symptom relief and quality of life, the method will have significant clinical relevance that may generate standard of care for patients with breast cancer.
ClinicalTrials.gov: NCT01591915.
乳腺癌诊断及其治疗带来的压力会产生各种心理社会后果，包括免疫反应受损。正念减压（MBSR）是一种结构化的补充方案，其中包括冥想、瑜伽和身心练习。尽管 MBSR 的疗效有令人鼓舞的实证证据，但仍需要进行随机对照试验（RCT）。还需要 RCT 来研究心理社会干预对乳腺癌女性情绪障碍和免疫反应的疗效。因此，总体目标是确定正念减压（MBSR）干预对乳腺癌女性的幸福感和免疫反应的疗效。
在这项 RCT 中，将连续招募被诊断为乳腺癌的患者参与。参与者将随机分为三组：MBSR 干预 I（每周小组会议+自我指导计划）、MBSR 干预 II（自我指导计划）和对照组（非 MBSR）。在干预开始前、3、6、12 个月收集数据，此后每年收集数据，最长可达 5 年。这项研究可能有助于为 MBSR 的疗效提供基于证据的知识，以支持患者增强力量，在乳腺癌疾病中恢复健康。
本研究可能有助于为正念训练的疗效提供基于证据的知识，以支持患者增强力量，在乳腺癌疾病中恢复健康。如果 MBSR 对缓解症状和提高生活质量有效，那么该方法将具有重要的临床相关性，可能为乳腺癌患者生成护理标准。
ClinicalTrials.gov：NCT01591915。
