Rectal Cancer Clinical Trial
Official title:
Exercise for Adults Diagnosed With Rectal Cancer: A Feasibility Study
Currently, there is no clear indication if exercise is safe and if it confers health benefits
for adults across the cancer trajectory (i.e., from diagnosis onward) for rectal cancer - a
population who may have limited exercise tolerance and who may be at an increased risk for
adverse events associated with exercise. In this prospective single-arm feasibility trial, we
aim to examine the safety and feasibility of a 12-week exercise intervention for adults
diagnosed with rectal cancer to inform the development of a large-scale randomized controlled
trial that will assess the efficacy of exercise administered across the cancer trajectory for
for rectal cancer. Adults who have been diagnosed with rectal cancer and are currently
undergoing or have completed treatment (within the last five years) will be recruited over a
12-month period into a supervised exercise intervention consisting of aerobic and strength
training to be done three times per week. Feasibility, safety, patient-reported outcomes, and
physical tests will be performed pre-intervention and post-intervention. This study will
provide data on the feasibility of an exercise intervention and will help determine if it is
safe to progress with a large-scale randomized controlled trial to test the benefits of
exercise for adults diagnosed with rectal cancer. It will also provide initial estimates of
the parameters for patient-reported outcomes, which are required to calculate the sample size
for the large-scale randomized controlled trial to ensure it is sufficiently powered.
The purpose of this prospective single-arm feasibility trial is to determine if a 12-week
exercise intervention offered to adults diagnosed with rectal cancer surviviors is safe and
feasible.
The specific objectives are to:
1. Test the feasibility and safety of a 12-week exercise intervention;
2. Obtain initial estimates of the parameters of the main outcomes to inform sample size
calculations for the main study (i.e., means and standard deviations for
patient-reported and physical outcomes);
3. Determine the opportune time in the cancer trajectory for rectal cancer to deliver a
12-week exercise intervention.
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