A dyadic exercise approach to prevent declines in physical and mental health in couples during radiation treatment for cancer: a hybrid type I efficacy-implementation trial

预防癌症放射治疗期间夫妇身心健康下降的二元运动方法：I 型混合疗效实施试验

• 批准号: 10751976
• 负责人: KERRI M WINTERS-STONE
• 金额: $ 56.03万
• 依托单位: OREGON HEALTH & SCIENCE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10751976
• 关键词: Address; Administrator; Aftercare; Anxiety; Biometry; Breast Cancer survivor; COVID-19; Cancer Patient; Cancer Survivor; Caring; Categories; Cessation of life; Chronic Disease; Clinic; Clinical; Collaborations; Communication; Control Groups; Couples; Data; Diagnosis; Dose; Educational process of instructing; Emotional; Exercise; Face; Fatigue; Feasibility Studies; General Population; Health; Health Personnel; Heart Diseases; Hybrids; Hypertension; Individual; Inflammation; Insulin Resistance; Intervention; Malignant Neoplasms; Malignant neoplasm of prostate; Marriage; Mental Depression; Mental Health; Metabolic syndrome; Methods; Morbidity - disease rate; Nature; Newly Diagnosed; Obesity; Oncology; Outcome; Pathway interactions; Patient Care; Patients; Physical Function; Physical Rehabilitation; Play; Process; Process Measure; Prostate Cancer therapy; Psyche structure; Publications; Qualitative Methods; Quality of life; Radiation Oncology; Radiation therapy; Randomized; Recommendation; Reporting; Role; Sampling; Science; Self Efficacy; Sleep; Social support; Spouses; Supportive care; Survivors; Technology; Testing; Time; Training; Woman; Work; acceptability and feasibility; adverse outcome; biopsychosocial; cancer care; cancer diagnosis; cancer therapy; clinical care; clinical practice; cost; design; disability; effectiveness/implementation study; effectiveness/implementation trial; efficacy testing; efficacy/implementation trial; exercise program; exercise training; experience; falls; fitness; follow-up; fortification; future implementation; high risk; implementation science; improved; information gathering; innovation; intimate behavior; malignant breast neoplasm; member; men; mortality; multidisciplinary; phase II trial; physical conditioning; point of care; post intervention; prevent; programs; prostate cancer survivors; psychosocial; randomized controlled design; remote delivery; satisfaction; sex; symptom management; theories; treatment as usual; usual care arm

Breast and prostate cancer are two of the most common and survivable cancers and most survivors of these cancers will be married when diagnosed. Compared to couples that aren't facing a chronic illness, both cancer survivors and their spouses suffer from poorer physical and mental health that leads higher morbidity and mortality. Since couples experience and navigate an illness together their health becomes intertwined, thus programs aimed at one member of the dyad ignore the interdependent nature of the couple. Exercise improves quality of life among cancer survivors; but, we were the first to adapt exercise to be a partnered activity that amplifies the dose of exercise and builds teamwork to improve dyadic outcomes (i.e., physical and mental health of patients and partners). We developed and piloted Exercising Together in prostate cancer survivors and their spouses long after his diagnosis. The pilot showed that six months of partnered exercise could improve physical and mental health in both partners as well as their intimate relationship. We believe the program would be most effective at mitigating the impact of newly diagnosed cancer and treatment on the physical and mental health of each partner if implemented much earlier in the point of care for patients. We have preliminary data on 10 couples who participated in an adapted version of Exercising Together during his radiation treatment for prostate cancer (6-8 weeks). The adapted program is much shorter (8 v. 24 wks.) than the original and is more focused on developing teamwork as a mechanism to amplify the benefits of exercise on dyadic outcomes. All couples completed the program and improved physical and mental health and their level of communication; however, we had no control group so we cannot be certain if the program is efficacious or not nor how long lasting the effects of the program might be. We now propose a Type I hybrid effectiveness-implementation trial of Exercising Together adapted for the radiation oncology setting. This design allows us to formally test the efficacy of a clinic- based version of Exercising Together using a randomized controlled design, a larger sample, a broader set of outcomes, and a follow-up period. We will also examine putative dyadic mechanisms to explain how our intervention improves dyadic health. At the same time, we will gather critical information from multiple stakeholders to inform future implementation approaches to integrate Exercising Together into the care plan for cancer patients. We propose a randomized controlled Phase II trial in 200 couples who will be randomly assigned to participate in an 8-week program of Exercising Together at the start of his/her radiation therapy or to a usual care control group that receives standard exercise guidance and receipt of a video of the couples program at the end of participation. Couples are tested at baseline, post-intervention (2 mos.), and 4- and 6-mos. follow up. Based on adaptations in other trials developed during COVID19, exercise training and assessments will be delivered through remote technology, which allows us to better diversity the sample and widen the scalability of the program.

乳腺癌和前列腺癌是最常见和可存活的两种癌症，而且大多数幸存者 确诊后，巨蟹座将会结婚。与没有面临慢性病的夫妇相比，两种癌症 幸存者及其配偶的身心健康较差，导致更高的发病率和 死亡率。由于夫妻共同经历和应对疾病，他们的健康变得相互交织在一起，因此 针对这对夫妇中的一个成员的节目忽略了这对夫妇相互依存的本质。锻炼对身体有改善作用 癌症幸存者的生活质量；但是，我们是第一个将锻炼调整为合作活动的人， 增加运动量并建立团队合作，以改善二元结果(即，身心健康 患者和伴侣)。我们开发并试行了前列腺癌幸存者和他们的共同锻炼 夫妻在他确诊后很久才结婚。这项试验表明，六个月的搭档锻炼可以改善身体状况 以及双方的心理健康以及他们的亲密关系。我们相信这个项目将是世界上 有效缓解新诊断癌症和治疗对老年人身心健康的影响 如果在更早的时候实施每个伙伴对病人的护理。我们有10对夫妇的初步数据 在前列腺癌的放射治疗期间，他参加了一种经过调整的一起锻炼的版本 (6-8周)。改编的节目要短得多(8比24周。)而不是原来的，更专注于 发展团队合作作为一种机制，放大锻炼对二元结果的好处。所有情侣 完成了计划，改善了身心健康和沟通水平；然而，我们 没有对照组，所以我们不能确定该计划是否有效，也不能确定效果持续多久 可能是计划的一部分。我们现在提出了一种I型混合有效性-实施锻炼试验 一起适应放射肿瘤学的环境。这种设计使我们能够正式测试诊所的疗效- 基于版本的锻炼使用随机对照设计，样本更大，集合范围更广 结果，以及一个随访期。我们还将研究假定的二元机制，以解释我们的 干预改善了二元人的健康。同时，我们将从多个方面收集关键信息 利益攸关方告知未来的实施方法，以将共同锻炼纳入护理计划 癌症患者。我们建议在200对夫妇中随机分配一项随机对照的第二阶段试验 参加一个为期8周的计划，在他/她的放射治疗开始时一起锻炼，或参加通常的 护理控制组，接受标准运动指导，并在 参与结束。夫妇在基线、干预后(2个月)、4个月和6个月进行测试。继续跟进。 根据在COVID19期间开发的其他试验的适应情况，运动训练和评估将 通过远程技术提供，这使我们能够更好地使样本多样化，并扩大 这个项目。