Exercise for Adults Diagnosed With Rectal Cancer

Study Overview
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Brief Summary
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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: Test the feasibility and safety of a 12-week exercise intervention; 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); Determine the opportune time in the cancer trajectory for rectal cancer to deliver a 12-week exercise intervention.

Official Title
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Exercise for Adults Diagnosed With Rectal Cancer: A Feasibility Study

Conditions
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Rectal Cancer

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion criteria are: Men and women 18 to 85 years of age; Diagnosed and/or completed treatment for stage I-III rectal cancer within the last 5 years; Able to read/understand English or French; Ambulatory; Live <50km of the University of Ottawa; Approval of healthcare provider to participate in the intervention. Exclusion criteria are: Congestive heart failure, clinically significant aortic stenosis, history of cardiac arrest, use of a cardiac defibrillator, uncontrolled angina, uncontrolled arrhythmia, myocardial infarction, major heart surgery, stroke, or pulmonary embolus; A diagnosis of hypertension or a resting blood pressure of 160/90 mmHg or higher (i.e., systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 90 mmHg); The use of supplemental oxygen; Severe arthritis (i.e., osteoarthritis or rheumatoid arthritis); History of chest pain or severe shortness of breath either at rest or when engaging in physical activity; Hip fracture, hip or knee replacement in the past 6 months; Impairments requiring mobility aids; Stage V cancer; Prior cancer diagnosis, excluding non-melanoma skin cancer; Participating in another exercise trial; Unwilling/unable to give informed consent. Of note, in addition to the exclusion criteria listed above, for individuals who are about to begin or are undergoing treatment healthcare providers will also employ clinical judgment concerning participant safety; that is, if the healthcare provider judges the patient to be at high risk for adverse events or medical complications if they participate in the intervention given their health status, they will not approach the patient to obtain permission for research personnel from the University of Ottawa to contact them.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Participants will be asked to complete a 12-week exercise intervention and all study assessments. | Behavioral: Exercise<br>* Participants will engage in supervised exercise 3 times per week for 60-75 minutes/session for 12 weeks. Sessions will include a warm-up (aerobic activity less than < 60% of heart rate reserve), aerobic training (30 minutes of exercise at 60-75% of heart rate reserve, using cycle ergometers/treadmills), strength training (8 exercises; upper body, lower body, and core), and a cool-down (aerobic activity less than < 60% of heart rate reserve) component.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rates | The number of eligible participants who enrol in the study out of the number who are referred. | Through study completion, an average of 12 weeks | 
| Retention Rates | The number of participants completing the intervention and all scheduled assessments. | Through study completion, an average of 12 weeks | 
| Adherence Rates | The number of exercise sessions completed out of 36. | Through study completion, an average of 12 weeks | 
| Number of Participants with Adverse Events | The number of participants reporting or presenting adverse events (e.g., injury) that occurs as a result of participating in the exercise sessions and/or its assessments. | Through study completion, an average of 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer, Exercise, Feasibility trial, Chemoradiation