Individually Prescribed Exercise Versus Usual Care in a Heterogeneous Cancer Survivor Population: A Pragmatic Randomized Controlled Trial
Background: Many cancer survivors suffer a range of physical and psychological symptoms with
may persist for years or months after treatment finishes. Despite the known benefits of
exercise and its potential to address many of these adverse effects of treatment, the role
of exercise as well as its optimum duration, frequency, and intensity in this population has
yet to be fully elucidated. Many cancer rehabilitation programmes presented in the
literature are very long, have tight eligibility criteria and are not likely to be practical
in the majority of cancer survivors. We plan to investigate a novel brief 8-week
intervention which aims to increase physical fitness, and address other physical symptoms in
a heterogeneous cancer survivor population.
Methods/design: Approximately 60 cancer survivors 2-6 months after completion of
chemotherapy, usually adjuvant, with curative intent will be recruited through oncology
clinics in a single institution and randomised to usual care or an exercise intervention.
The exercise intervention consists of two specifically tailored, supervised, moderate
intensity aerobic exercise sessions per week for 8 weeks. All participants will be assessed
at baseline (0 weeks), post intervention (8 weeks), and at 3-month follow-up. The primary
outcome measure is fitness, and secondary patient-related outcome measures include fatigue,
quality of life, and morphological outcomes. A further secondary outcome is process
evaluation including adherence to and compliance with the exercise program.
Discussion: This study will provide valuable information about the physical outcomes of this
8-week supervised aerobic programme. Additional process information and economic evaluation
will inform the feasibility of implementing this program in a heterogeneous population after
chemotherapy treatment with curative intent.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Modified Bruce Treadmill Test (Fitness)
0, 8 weeks, 3 months
Dearbhaile O' Donnell, MD
St. James's Hospital, Dublin, Ireland
Ireland: Medical Ethics Research Committee