Grant Number:	1R01CA277738-01A1 Interpret this number
Primary Investigator:	Winters-Stone, Kerri
Organization:	Oregon Health & Science University
Project Title:	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
Fiscal Year:	2023

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.





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