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

Abstract

TPS410 Background: Compared to couples that aren’t facing a chronic illness, both cancer patients and their spouses suffer from poorer physical and mental health that leads higher morbidity and mortality. Exercising Together is a partnered exercise program aimed to amplify the dose of exercise and build teamwork to improve dyadic outcomes (i.e., physical and mental health of patients and partners) but has only been tested in the post-treatment setting as a rehabilitation strategy. We posit that the program would be most effective at mitigating the impact of newly diagnosed cancer and treatment if implemented much earlier in the point of care for patients and was delivered in a scalable way. Methods: The EMBark on RAdiation therapy with a Clinic-based Exercise program: Exercising Together (EMBRACE Exercising Together ) is a Type I hybrid effectiveness-implementation trial of Exercising Together adapted for the radiation oncology setting. This randomized controlled Phase II trial randomly assigns couples (n=200) to participate in an 8-week program of Exercising Together (3 x/ week) at the start of radiation therapy for prostate or breast cancer or to a usual care control group that receives standard written exercise guidance each month and receipt of a video of the Exercising Together at the end of participation. Couples assigned to the intervention group have the option to continue exercising in a maintenance class for another 48 weeks. Eligible survivors must have a diagnosis of prostate or breast cancer, be scheduled to receive radiation therapy with curative intent, and have a co-residing partner willing to participate; Eligible survivors and partners must be >18 years, not currently engaged in resistance training, and have no contraindications to participation. Couples are tested at baseline, post-intervention (2 mos.), and 4- and 6-mos. follow up. Assessments include online surveys (physical functioning, fatigue, sleep, anxiety, depressive symptoms, sexual function and satisfaction, quality of life, physical activity, health care utilization, relationship quality, physical intimacy, communication, collaboration social support, and self-efficacy); internet-based physical performance battery (chair stand, walk speed, balance tests); actigraphy-based physical activity and sleep behavior; high-sensitivity C-Reactive Protein using a dried blood spot technique. Exercise training and assessments are delivered through remote technology and/or collected at home. Intent-to-treat analysis will compare Exercising Together vs. usual care on physical and mental health of the dyad. Implementation outcomes of acceptability, appropriateness, adoption, sustainability and cost will be assessed, tracked, and analyzed. Trial registration: ClinicalTrials.gov, NCT06049355. Clinical trial information: NCT06049355 .