Evaluate Impact of Exercise Program on Fatigue in Breast Cancer During Chemotherapy

Study Overview
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Brief Summary
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Assess feasibility of home exercise in reducing fatigue in subjects with breast cancer receiving curative intent chemotherapy. Subjects are randomized to control (no exercise) or intervention group (exercise). The PRO-CTCAE tool and FACIT Fatigue Scale are used to collect patient reported outcomes. Subjects submit data via mobile phone, tablet or computer. Assessments are weekly during chemotherapy (10-20 wks), at end of chemotherapy and 1, 3 and 6 months after chemotherapy.

Detailed Description
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The goal of this project is to determine the feasibility of a specific home-based exercise intervention in reducing cancer-related fatigue (CRF) in breast cancer patients undergoing curative-intent chemotherapy. The outcome will be measured by using the FACIT Fatigue Scale, administered by using the Carevive PROmpt® platform. Primary Objectives: . To examine the feasibility of recruitment and retention of women undergoing treatment for breast cancer over the duration of the chemotherapy regimen. To examine the adherence to the exercise regime for those in the intervention group and compare the retention rates between treatment and control groups To compute the means and standard deviations (SD) of the FACIT responses over time in both groups for use in future power analyses to aid in the design of a futre hypothesis testing RCT. Secondary Objectives: To quantify the change over time in PRO-CTCAE derived symptoms and other PROs by computing means and SD. To test for group differences in the trajectory of change over time in FACT using a Mixed Model repeated analysis

Official Title
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Pilot Study to Evaluate the Impact of a Home-Based Exercise Program on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Curative-Intent Chemotherapy

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with curative-intent breast cancer who plan to undergo at least 4 cycles of chemotherapy. Age > 18 years ECOG performance score < 3 English-speaking with sufficient vision/hearing or family support Coronary artery disease, if cleared by cardiologist Subject must have smart phone, computer or tablet. Willingness to be randomized Exclusion Criteria: Medical or psychiatric conditions (beyond those related to breast cancer and its treatment) that would impair our ability to test study hypotheses (psychotic disorders, dementia, inability to give informed consent or follow instructions). Patients with overt evidence of a psychiatric disorder. Coronary artery disease, not cleared by cardiologist. Contraindication to exercise. Chronic fatigue syndrome.

Ages Eligible for Study
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Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Exercise<br>Intervention: Subject will be assessed by a Physical Therapist. Based on the assessment, the Physical Therapist will provide the patient with a home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. Patients will be asked to complete a symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue. | Behavioral: Exercise<br>* Home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises.<br>* Other names: Exercise program;|
| No Intervention: Control<br>Subject will not be provided an exercise program but will be asked to complete the symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. | The outcome will be measured by using the FACIT Fatigue Scale 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much). | Baseline | 
| Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. | Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much). | Weekly for 12 weeks | 
| Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. | Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much). | Month 1 following completion of chemotherapy | 
| Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. | Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much). | Month 3 following completion of chemotherapy | 
| Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. | Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much). | Month 6 following completion of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To quantify the change over time in PRO-CTCAE derived symptoms | Outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following sale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe. | Baseline | 
| To quantify the change over time in PRO-CTCAE derived symptoms | Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe. | Weekly for 12 weeks | 
| To quantify the change over time in PRO-CTCAE derived symptoms | Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe. | Month 1 following completion of chemotherapy | 
| To quantify the change over time in PRO-CTCAE derived symptoms | Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe. | Month 3 following completion of chemotherapy | 
| To quantify the change over time in PRO-CTCAE derived symptoms | Changes in symptoms will be assessed this outcome will be measured using PRO-CTCAE Derived Symptoms and other PROs. A scale Yes or No is utilized to describe whether the following symptoms have been experienced: Anxiety, constipation, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth sores, muscle pain, nausea, numbness and tingling, problems and concentration, rash, sad, shortness of breath, vomiting. The following scale: Rarely, occasionally, frequently or almost constantly will be used to measure anxiety and general pain. Severity of the following symptoms: Anxiety, fatigue, general pain and problems with concentration in a 7 day time period will be measured using the following scale: Mild, Moderate, Severe, Very Severe. | Month 6 following completion of chemotherapy |