Rectal Cancer
Conditions
Keywords
Exercise, Feasibility trial, Cancer, Chemoradiation
Brief summary
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.
Interventions
BEHAVIORALExercise
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.
Sponsors
University of Ottawa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
are: 1. Men and women 18 to 85 years of age; 2. Diagnosed and/or completed treatment for stage I-III rectal cancer within the last 5 years; 3. Able to read/understand English or French; 4. Ambulatory; 5. Live \<50km of the University of Ottawa; 6. Approval of healthcare provider to participate in the intervention.
Exclusion criteria
are: 1. 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; 2. 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); 3. The use of supplemental oxygen; 4. Severe arthritis (i.e., osteoarthritis or rheumatoid arthritis); 5. History of chest pain or severe shortness of breath either at rest or when engaging in physical activity; 6. Hip fracture, hip or knee replacement in the past 6 months; 7. Impairments requiring mobility aids; 8. Stage V cancer; 9. Prior cancer diagnosis, excluding non-melanoma skin cancer; 10. Participating in another exercise trial; 11. Unwilling/unable to give informed consent. Of note, in addition to the
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment Rates | Through study completion, an average of 12 weeks | The number of eligible participants who enrol in the study out of the number who are referred. |
| Retention Rates | Through study completion, an average of 12 weeks | The number of participants completing the intervention and all scheduled assessments. |
| Adherence Rates | Through study completion, an average of 12 weeks | The number of exercise sessions completed out of 36. |
| Number of Participants with Adverse Events | Through study completion, an average of 12 weeks | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Affect: Positive and Negative Affect Schedule (Watson et al., 1988) | Baseline (week 0) and post-intervention (week 12) | Change in self-reported affect from baseline to post-intervention. |
| Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985) | Baseline (week 0) and post-intervention (week 12) | Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention. |
| Resting Heart Rate: Heart Rate Monitor (Polar A300) | Baseline (week 0) and post-intervention (week 12) | Change in resting heart rate from baseline to post-intervention. |
| Body Mass Index: Tanita Scale (TBF-310 GS) | Baseline (week 0) and post-intervention (week 12) | Change in body mass index from baseline to post-intervention. |
| Aerobic Capacity: 6-Minute Walk Test (Canadian Society for Exercise Physiology, 2013; Irwin, 2012) | Baseline (week 0) and post-intervention (week 12) | Change in aerobic capacity (i.e., total distance walked in 6 minutes) from baseline to post-intervention. |
| Musculoskeletal Strength: Combined Grip Strength Using a Handheld Dynamometer (Canadian Society for Exercise Physiology, 2013, 2013; Irwin, 2012) | Baseline (week 0) and post-intervention (week 12) | Change in musculoskeletal strength (i.e., force exerted in kilograms on the handheld dynamometer) from baseline to post-intervention. |
| Socio-Demographic and Medical Information Questionnaire | Baseline (week 0) | The socio-demographic and medical information collected will be used to describe the sample. |
| Blood Pressure: Blood Pressure Monitor (HealthSmart Digital Blood Pressure Monitor) | Baseline (week 0) and post-intervention (week 12) | Change in resting blood pressure from baseline to post-intervention. |
| Quality of Life: Functional Assessment of Cancer Therapy - Colorectal (Ward et al., 1999; Yost et al., 2005) | Baseline (week 0) and post-intervention (week 12) | Change in self-reported quality of life from baseline to post-intervention. |
| Cognitive Functioning: Functional Assessment of Cancer Therapy - Cognitive Function (Wagner et al., 2004) | Baseline (week 0) and post-intervention (week 12) | Change in self-reported cognitive function from baseline to post-intervention. |
| Symptoms of Fatigue: the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (Yellen et al., 1997) | Baseline (week 0) and post-intervention (week 12) | Change in self-reported fatigue from baseline to post-intervention. |
Countries
Canada
Outcome results
None listed