Renewing caregiver health and wellbeing through exercise (RECHARGE): A randomized controlled trial.

Background: Family caregivers (FCs) to cancer patients are at increased risk for physical and emotional health problems as a result of being in the caregiver role. Current research on interventions for FCs has focused on psychological support or educational interventions, with very little investigation of exercise in maintaining or improving health. Based on our preliminary survey, participation in regular exercise to improve health was noted as a priority for FCs. The purpose of the study described in this protocol is to examine the impact of a 12-week structured exercise program on physical functioning (primary outcome), physical activity levels and psychological well-being (secondary outcomes), in FCs caring for adult cancer patients. In addition, the trial described here will examine the outcomes from a 12-week maintenance program, immediately following the initial program.

Methods/design: A mixed methods design using a randomized control trial (RCT) with a 50/50 allocation ratio for the quantitative portion, followed by face to face interviews and qualitative data analysis. Approximately 86 participants will be enrolled over a 10 month period. The intervention will consist of a structured exercise program of aerobic and resistance training. An intention to treat principle using mixed effects modeling will guide data analysis.

Discussion: FCs will continue to play a pivotal role in the care of cancer patients as the incidence and chronicity of cancer increases. The research described in this protocol will provide information about the impact of an exercise program in supporting FC health.

Trial Registration: ClinicalTrials.gov Identifier: NCT02580461.