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Exercise for Adults Diagnosed With Rectal Cancer

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ClinicalTrials.gov Identifier: NCT03049124
Recruitment Status : Recruiting
First Posted : February 9, 2017
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Jennifer Brunet, University of Ottawa

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.

Condition or disease Intervention/treatment Phase
Rectal Cancer Behavioral: Exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Exercise for Adults Diagnosed With Rectal Cancer: A Feasibility Study
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : April 30, 2019
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exercise
Participants will be asked to complete a 12-week exercise intervention and all study assessments.
Behavioral: Exercise
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.




Primary Outcome Measures :
  1. Recruitment Rates [ Time Frame: 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.

  2. Retention Rates [ Time Frame: Through study completion, an average of 12 weeks ]
    The number of participants completing the intervention and all scheduled assessments.

  3. Adherence Rates [ Time Frame: Through study completion, an average of 12 weeks ]
    The number of exercise sessions completed out of 36.

  4. Number of Participants with Adverse Events [ Time Frame: 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 Outcome Measures:
  1. Quality of Life: Functional Assessment of Cancer Therapy - Colorectal (Ward et al., 1999; Yost et al., 2005) [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in self-reported quality of life from baseline to post-intervention.

  2. Cognitive Functioning: Functional Assessment of Cancer Therapy - Cognitive Function (Wagner et al., 2004) [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in self-reported cognitive function from baseline to post-intervention.

  3. Symptoms of Fatigue: the Functional Assessment of Chronic Illness Therapy - Fatigue Scale (Yellen et al., 1997) [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in self-reported fatigue from baseline to post-intervention.

  4. Affect: Positive and Negative Affect Schedule (Watson et al., 1988) [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in self-reported affect from baseline to post-intervention.

  5. Physical Activity Behaviour: Leisure Time Exercise Questionnaire (Godin & Shephard, 1985) [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in self-reported physical activity (over the past 7 days) from baseline to post-intervention.

  6. Resting Heart Rate: Heart Rate Monitor (Polar A300) [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in resting heart rate from baseline to post-intervention.

  7. Blood Pressure: Blood Pressure Monitor (HealthSmart Digital Blood Pressure Monitor) [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in resting blood pressure from baseline to post-intervention.

  8. Body Mass Index: Tanita Scale (TBF-310 GS) [ Time Frame: Baseline (week 0) and post-intervention (week 12) ]
    Change in body mass index from baseline to post-intervention.

  9. Aerobic Capacity: 6-Minute Walk Test (Canadian Society for Exercise Physiology, 2013; Irwin, 2012) [ Time Frame: 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.

  10. Musculoskeletal Strength: Combined Grip Strength Using a Handheld Dynamometer (Canadian Society for Exercise Physiology, 2013, 2013; Irwin, 2012) [ Time Frame: 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.

  11. Socio-Demographic and Medical Information Questionnaire [ Time Frame: Baseline (week 0) ]
    The socio-demographic and medical information collected will be used to describe the sample.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03049124


Contacts
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Contact: Jennifer Brunet, PhD 613-562-5800 ext 3068 jennifer.brunet@uottawa.ca
Contact: Amanda Wurz, MSc 613-562-5800 ext 3626 amanda.wurz@uottawa.ca

Locations
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Canada, Ontario
University of Ottawa Recruiting
Ottawa, Ontario, Canada, K1N 6N5
Contact: Amanda Wurz, MSc    613-562-5800 ext 3626    amanda.wurz@uottawa.ca   
Sponsors and Collaborators
University of Ottawa
Investigators
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Principal Investigator: Jennifer Brunet, PhD University of Ottawa

Publications:
Canadian Society for Exercise Physiology. Canadian Society for Exercise Physiology - Physical activity training for health. Ottawa, ON: Canadian Society for Exercise Physiology, 2013.
Irwin ML. ACSM's guide to exercise and cancer survivorship. Champaign, IL: American College of Sports Medicine, 2012.
Wagner LI, Cella D, Sweet J, Forrestal S. (2004). Chemotherapy-related cognitive deficits: development of the FACT-Cog instrument. Ann Behav Med, 27, S10.

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Responsible Party: Jennifer Brunet, Assistant Professor, University of Ottawa
ClinicalTrials.gov Identifier: NCT03049124     History of Changes
Other Study ID Numbers: RectalCaEx-JB-MV-KC
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jennifer Brunet, University of Ottawa:
Exercise
Feasibility trial
Cancer
Chemoradiation

Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases