Impact of a COmprehensive cardiac REhabilitation framework among high cardiovascular risk cancer survivors: protocol for the CORE trial

Abstract

Background: Cancer survivors are challenging patients, as they often present increased cardiovascular risk. In this background, cardio-oncology rehabilitation frameworks for specific cancer patients have been proposed. How- ever, optimal program designs, as well as their overall safety and efficacy in different subsets of patients, are not fully ascertained. Design: Single-center, pragmatic, prospective, randomized controlled trial performed in Portugal aiming to evaluate the impact of a center-based cardiac rehabilitation program, consisting of exercise training, nutritional counselling, psychosocial management and lifestyle behavior change, compared to community-based exercise training, in cancer survivors. Methods: Adult cancer survivors (N = 80) exposed to cardiotoxic cancer treatment and/or with previous car- diovascular disease will be randomized (1:1) to receive either an eight-week cardiac rehabilitation program or community-based exercise training. Primary endpoint is cardiorespiratory fitness; secondary endpoints are physical activity, psychosocial parameters, blood pressure, body composition, lipids and inflammatory param- eters. Physical function, quality of life, fatigue, health literacy, and feasibility will be assessed; a cost- effectiveness evaluation will also be performed. Between-group differences at baseline and in the change from baseline to the end of the study will be tested with unpaired t-tests or Mann-Whitney U test. Paired t-tests or Wilcoxon signed-rank test will be performed for within-group comparisons. Conclusion: This trial will address the overall impact of a contemporary cardiac rehabilitation program frame- work in cancer survivors, as compared to a community-based exercise training.