Exercise for Breast Cancer Patients (EXCAP)

Study Overview
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Brief Summary
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The purpose of this study is to examine if exercise helps improve cancer-related fatigue. Hypothesis: A structured home-based walking and progressive resistance exercise program will be efficacious in relieving cancer-related fatigue, preventing aerobic and anaerobic deconditioning and skeletal muscle wasting, as well as improving inflammatory cytokine profiles in breast cancer survivors as well as those receiving radiation treatment.

Detailed Description
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Fatigue is a frequently reported side effect of cancer treatment. Fatigue related to cancer and its treatment is different from fatigue occurring in other situations and its specific causes have not been identified. Exercise may or may not improve this type of fatigue. The purpose of this study is to examine how cancer treatments impact normal lifestyle physical activity patterns and participation in physical activity, as well as the ability of a walking and progressive resistance exercise program to reduce cancer-related fatigue in breast cancer patients. This study also examines if the walking and progressive resistance exercise program improves other factors such as quality of life, depression, anxiety, ability to sleep, self esteem, cardiovascular fitness, energy expenditure, muscular strength, muscle mass, and immune function (as measured by inflammatory cytokines).

Official Title
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Aerobic and Resistance Exercise for Cancer Treatment-Related Fatigue

Conditions
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Fatigue

Intervention / Treatment
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* Behavioral: Exercise
* Behavioral: Progressive walking and resistance exercise treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have a primary diagnosis of breast cancer, Have a functional capacity rating of 60 or greater on the Karnofsky Performance Scale, when assessed by the oncologist (or physician's designee) Be breast cancer survivor(e.g., surgery, radiation therapy, chemotherapy, hormone therapy). Have a life expectancy of >1 year as determined by the patient's oncologist. Have the approval of their treating physician, study physician(or physician's designee) to participate in sub-maximal physiological fitness testing and a low to moderate home-based walking and progressive resistance exercise program. Be able to read English. Be 21 years of age or older. Give informed consent. Exclusion Criteria: Have bone metastases that preclude participation in an exercise program either due to symptoms such as pain or location of bone metastasis. Have physical limitations (i.e. cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in sub-maximal physiological fitness testing, or a low to moderate home-based walking and progressive resistance program, as assessed by the PAR-Q and radiation oncologist (or physician's designee) Be identified as in the Active or Maintenance Stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Arm 1<br>Usual Care: Standard care monitoring | Behavioral: Exercise<br>* Standard care monitoring<br>* Other names: Usual care: standard care monitoring;|
| Experimental: Arm 2<br>Progressive walking and resistance exercise treatment | Behavioral: Progressive walking and resistance exercise treatment<br>* Home-based exercise : Progressive walking and resistance program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer-related fatigue |  | 4.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide preliminary data on influence of QOL and it's relationship to CRF |  | 4.5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise, Breast cancer, fatigue