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

Virtua Health

Status: Enrolling

Conditions: Breast Cancer

Treatments: Behavioral: Exercise

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05704842

IRB-2021-04

Details and patient eligibility

About

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.

Full description

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:

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

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Exercise

Other group

Description:

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.

Treatment:

Behavioral: Exercise

Control

No Intervention group

Description:

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.