Evaluate Impact of Exercise Program on Fatigue in Breast Cancer During Chemotherapy
NCT ID: NCT05704842
Last Updated: 2024-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2022-12-22
2026-06-01
Brief Summary
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Detailed Description
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Primary Objectives:
1. . To examine the feasibility of recruitment and retention of women undergoing treatment for breast cancer over the duration of the chemotherapy regimen.
2. To examine the adherence to the exercise regime for those in the intervention group and compare the retention rates between treatment and control groups
3. 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:
1. To quantify the change over time in PRO-CTCAE derived symptoms and other PROs by computing means and SD.
2. To test for group differences in the trajectory of change over time in FACT using a Mixed Model repeated analysis
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
OTHER
NONE
Study Groups
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Exercise
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.
Exercise
Home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises.
Control
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.
No interventions assigned to this group
Interventions
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Exercise
Home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with overt evidence of a psychiatric disorder.
* Coronary artery disease, not cleared by cardiologist.
* Contraindication to exercise.
* Chronic fatigue syndrome.
18 Years
FEMALE
No
Sponsors
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Carevive Systems, Inc.
INDUSTRY
Virtua Health, Inc.
OTHER
Responsible Party
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Principal Investigators
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Priya P Gor, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Penn Medicine
Locations
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Virtua Health
Voorhees Township, New Jersey, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB-2021-04
Identifier Type: -
Identifier Source: org_study_id
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