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

癌症生存的综合方法：多中心可行性和可接受性研究

基本信息

批准号：
10729453
负责人：
Anand Dhruva
金额：
$ 58.09万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-09-08 至 2026-05-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10729453
关键词：
Academy Acupressure Address Adherence Aftercare Asia Attention Ayurvedic Medicine Benchmarking Breast Cancer Patient Breast Cancer survivor Cancer Burden Cancer Intervention Cancer Survivor Cancer Survivorship Caring Clinical Clinical Research Complement Data Detection Development Diagnosis Diagnostic Educational Intervention Enrollment Fatigue Focus Groups Funding Goals Guidelines Health Health education Healthcare Impairment Integrative Medicine Intervention Left Life Style Low income Malignant Neoplasms Manuals Measures Medicine Methodology Minor Modeling Modernization Moods Morbidity - disease rate National Center for Complementary and Integrative Health Participant Patient Care Patients Personal Satisfaction Persons Pilot Projects Population Procedures Process Quality of life Randomized Randomized, Controlled Trials Reporting Research Research Design Sampling Site Sleep Sleep disturbances Survivors Symptoms System Testing Therapeutic Time Underrepresented Populations Universities Work Yoga acceptability and feasibility arm cancer care cancer complication cancer diagnosis cancer therapy clinical care comparison intervention curative treatments efficacy study efficacy trial experience global health implementation intervention improved improved outcome individualized medicine intervention delivery intervention refinement long-term sequelae malignant breast neoplasm mind/body multimodality nutrition patient oriented psychosocial recruit survivorship systems research therapy design treatment as usual trial design

项目摘要

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.

项目概要背景：目前美国有超过 400 万乳腺癌幸存者，另外还有到 2022 年，将有 287,000 人被诊断出来。尽管乳腺癌幸存者数量的增加反映了乳腺癌治疗领域的进步检测和治疗，向治疗后生存的过渡仍然具有挑战性。患者留下由于癌症诊断和治疗导致的后遗症导致生活质量（QOL）受损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护理方面的这一差距。我们为癌症幸存者开发并试点了综合医学干预措施，包括个性化治疗基于阿育吠陀医学的以患者为中心的身心干预，其中包括营养和生活方式方法，以及基于国家标准的引人入胜的全面健康教育干预措施生存指南。这两种干预措施在时间和注意力上是相互匹配的。我们之前的在一个地点进行的研究表明，这两种干预措施是可行的，并且癌症幸存者可以接受，并且随机化、保留和坚持这些干预措施是可以接受的可行的。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希望患者的整体健康、睡眠、疲劳和情绪表现出中度至大幅改善。方法：鉴于我们迄今为止的研究结果，我们在此申请中建议在多站点中执行关键的后续步骤（UCSF、Kaiser Permanente Northwest 和范德比尔特大学的站点）干预优化，以及可行性和可接受性测试。该提案将在乳腺癌人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) 在多地点环境中实施以及 (1b) 改善招聘和保留代表性不足的患者。 (2) 确定中西医结合治疗的可行性、可接受性和真实性多地点环境中的生存干预和研究设计。在目标 2 中，我们将进行三臂试点随机对照试验，其中乳腺癌幸存者将被随机分配（每组 N = 35）至其中一项综合医学干预结合常规护理或单独常规护理。这项 R01 研究将帮助我们确定多站点随机化、保留、依从性和保真度的可接受性和可行性环境。意义：从长远来看，如果这种方法被证明是有效的，它就有可能改变有利于强调解决症状、生活质量和福祉重要性的范式；这开发无毒和天然的健康方法；以及在医疗保健方面更加以患者为中心的关注。