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两种最常见且可存活的癌症，也是其中大多数的幸存者 癌症确诊后就可以结婚了。与没有面临慢性疾病的夫妇相比，两人都患有癌症 幸存者及其配偶的身心健康状况较差，导致发病率较高 死亡。由于夫妻一起经历和应对疾病，他们的健康变得紧密相连，因此 针对二人中的一个成员的方案忽视了这对夫妇相互依存的性质。运动改善 癌症幸存者的生活质量；但是，我们是第一个将锻炼变成一项合作活动的人 扩大运动量并建立团队合作以改善二元结果（即身体和心理健康 患者和合作伙伴）。我们在前列腺癌幸存者及其患者中开发并试点了“一起锻炼” 在他确诊后很久就与配偶结婚了。试点表明，六个月的合作锻炼可以改善身体状况 伴侣双方的心理健康状况以及他们的亲密关系。我们相信该计划将是最 有效减轻新诊断的癌症和治疗对身心健康的影响 如果每个合作伙伴都能更早地在患者护理点实施。我们有 10 对夫妇的初步数据 在前列腺癌放射治疗期间参加了改编版的一起锻炼 （6-8 周）。改编后的计划比原来的计划要短得多（8 周 24 周），并且更侧重于 发展团队合作作为一种机制，以扩大锻炼对二元结果的益处。所有情侣 完成该计划并改善身心健康及其沟通水平；然而，我们 没有对照组，因此我们无法确定该计划是否有效，也无法确定效果能持续多久 该计划可能是。我们现在提出一项锻炼的 I 型混合有效性实施试验 共同适应放射肿瘤学环境。这种设计使我们能够正式测试诊所的功效- 基于“一起锻炼”的版本使用随机对照设计、更大的样本、更广泛的集合 结果和随访期。我们还将研究假定的二元机制来解释我们的 干预改善二元健康。同时，我们也会从多个方面收集关键信息。 利益相关者告知未来的实施方法，将一起锻炼纳入护理计划 癌症患者。我们提议在 200 对夫妇中进行一项随机对照 II 期试验，这些夫妇将被随机分配 在放射治疗开始时或平时参加为期 8 周的一起锻炼计划 护理对照组接受标准运动指导并收到夫妻项目的视频 参与结束。夫妇在基线、干预后（2 个月）、4 个月和 6 个月时进行测试。跟进。 根据在新冠肺炎期间开发的其他试验的改编，运动训练和评估将 通过远程技术交付，这使我们能够更好地实现样本的多样性并扩大样本的可扩展性 程序。