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生存的两种癌症，其中大多数幸存者 诊断后癌症将结婚。与不面对慢性疾病的夫妇相比，两种癌症 幸存者及其配偶的身体健康状况较差，导致发病率更高和 死亡。由于夫妻经历并一起导航疾病，他们的健康就会交织在一起，因此 针对Dyad成员的计划忽略了这对夫妇的相互依存性。运动改善 癌症幸存者的生活质量；但是，我们是第一个适应锻炼的人，成为一项合作活动 放大运动的剂量并建立团队合作以改善二元成果（即身心健康 患者和伴侣）。我们在前列腺癌幸存者及其中共同开发并进行了锻炼 配偶在诊断后很长时间。飞行员表明六个月的伙伴运动可以改善身体 和两个伴侣的心理健康及其亲密关系。我们相信该计划最多 有效缓解新诊断的癌症和治疗对身心健康的影响 每个伴侣在对患者的护理时期内实施得多。我们有10对夫妇的初步数据 他在前列腺癌的放射治疗期间一起参加了适应性的锻炼版本 （6-8周）。改编程序比原始程序短得多（8v。24wks。 开发团队合作作为一种机制来扩大运动对二元成果的好处。所有夫妻 完成了该计划，并改善了身心健康及其沟通水平；但是，我们 没有对照组，所以我们不能确定该程序是否有效，也无法持续多长时间 该程序可能是。现在，我们提出了一项I型混合有效性实施试验 共同适用于辐射肿瘤学设置。这种设计使我们能够正式测试诊所的功效 使用随机控制设计，更大的样本，一组更广泛的一组 结果和后续期。我们还将检查假定的二元机制，以解释我们的 干预改善二元健康。同时，我们将从多个 利益相关者为将来的实施方法告知将锻炼整合到护理计划中的方法 癌症患者。我们在200对夫妇中提出了一个随机分配的随机对照II期试验 在他/她的放射疗法开始时，参加为期8周的锻炼计划或通常 接受标准锻炼指导和接收夫妻节目的视频的护理对照组 参与结束。在基线，干预后（2个月）以及4- mos时对夫妻进行测试。跟进。 基于在Covid19期间开发的其他试验中的适应，运动培训和评估将是 通过远程技术交付，这使我们能够更好地多样性样本并扩大了可扩展性 该程序。