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

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. However, 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 cardiovascular 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 parameters. 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 framework in cancer survivors, as compared to a community-based exercise training. Given the higher cardiovascular risk in several groups of cancer patients, our results could provide novel insights into optimized preventive strategies in this complex patient population.