Integrative Approaches for Cancer Survivorship: A Multi-Site Feasibility and Acceptability Study

项目总结 背景：目前美国有400多万乳腺癌幸存者，另有 到2022年，将有28.7万人被确诊。尽管越来越多的乳腺癌幸存者反映了在 在检测和治疗方面，向治疗后生存的过渡仍然具有挑战性。病人们只剩下 癌症诊断和治疗造成的后遗症导致生活质量(QOL)和 癌症带来的持续负担。目前几乎没有安全有效的方法来解决这一保健差距。我们 为癌症幸存者开发和试点了综合医学干预措施，包括个性化的 以及以患者为中心的以阿育吠陀医学为基础的心身干预，包括营养和 生活方式方法，以及以全国为基础的引人入胜和全面的健康教育干预 生存指南。这两种干预措施在时间和注意力上相互匹配。我们的前辈 在同一地点进行的研究表明，这两种干预措施是可行的和 癌症幸存者可以接受的随机化、保留和坚持这些干预措施是 可行。在这些先前的研究中，我们发现阿育吠陀干预显示出临床益处的前景。 患者在全球健康、睡眠、疲劳和情绪方面表现出中等到较大的改善。方法： 鉴于我们到目前为止的研究结果，我们建议在此应用程序中在多个站点进行关键的下一步 (加州大学旧金山分校、Kaiser Permanente Northwest和范德比尔特大学)干预优化，以及 可行性和可接受性测试。这项提议将在乳房种群中进行两个相互关联的步骤 癌症患者，有以下具体目标：(1)适应和优化阿育吠陀和健康教育 干预措施(1a)在多地点环境中执行和(1b)改善征聘和留住 代表不足的病人。(2)确定中西医结合的可行性、可接受性和保真性 多地点环境下的生存干预和研究设计。在目标2中，我们将进行一次三臂飞行 一项随机对照试验，乳腺癌幸存者将被随机(每组35人)分为以下一组 结合常规护理或单独常规护理的中西医结合干预。这项R01研究将帮助我们 确定跨多个站点的随机化、保留、坚持和保真度的可接受性和可行性 布景。重要意义：从长远来看，如果这种方法被证明是有效的，它有可能发生转变 赞成强调解决症状、生活质量和福祉的重要性的范式； 开发无毒和自然的健康方法；在医疗保健方面更加以患者为中心。

PROJECT SUMMARY BACKGROUND: There are currently more than 4 million breast cancer survivors in the U.S., and an additional 287,000 will be diagnosed in 2022. Although the growing number of breast cancer survivors reflect advances in detection and treatment, the transition to post-treatment survivorship remains challenging. Patients are left with sequelae due to their cancer diagnosis and treatment resulting in impairments in quality of life (QOL) and an ongoing burden from cancer. Few safe and effective approaches currently exist to address this gap in care. We have developed and piloted integrative medicine interventions for cancer survivors including a personalized and patient-centered Mind and Body intervention based on Ayurvedic Medicine, which includes nutrition and lifestyle approaches, and an engaging and comprehensive health education intervention based on national survivorship guidelines. The two interventions are matched to each other for time and attention. Our prior research, conducted at a single site, has demonstrated that these two interventions are feasible and acceptable for cancer survivors and that randomization, retention, and adherence to these interventions was feasible. In these prior studies, we found that the Ayurvedic intervention showed promise of clinical benefit with patients showing moderate to large improvements in global health, sleep, fatigue, and mood. METHODS: Given the results of our research to date, we propose in this application to conduct key next steps in multi-site (sites at UCSF, Kaiser Permanente Northwest, and Vanderbilt University) intervention optimization, and feasibility and acceptability testing. This proposal will conduct two interlinked steps in a population of breast cancer patients, with the following specific aims: (1) To adapt and optimize the Ayurveda and Health Education interventions (1a) for implementation in a multi-site setting and (1b) improving recruitment and retention of underrepresented patients. (2) To determine the feasibility, acceptability, and fidelity of the integrative medicine survivorship interventions and study design in a multi-site setting. In Aim 2, we will conduct a three-arm pilot randomized controlled trial in which breast cancer survivors will be randomized (N=35 per arm) to one of the integrative medicine interventions along with usual care or usual care alone. This R01 study will help us to determine acceptability and feasibility of randomization, retention, adherence, and fidelity across the multi-site setting. SIGNIFICANCE: In the long-term, if this approach is shown to be effective, it has the potential to shift the paradigm in favor of emphasizing the importance of addressing symptoms, quality of life and wellbeing; the development of non-toxic and natural approaches for health; and a more patient-centered focus in healthcare.