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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Exercise

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susan VanLoon, RN, CCRP; Phone Number: 8562477382; Email: svanloon@virtua.org

Study Locations

• United States
  • New Jersey
    • Voorhees, New Jersey, United States, 08043
      • Recruiting
      • Virtua Health
      • Contact: Susan VanLoon, RN, CCRP; Phone Number: 856-247-7382; Email: svanloon@virtua.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: 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 Names: Exercise program
No Intervention: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Virtua Health, Inc.
• Collaborators: Carevive Systems, Inc.
• Investigators: Principal Investigator: Priya P Gor, MD, MSCE, Penn Medicine

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2022
• Primary Completion (Estimated): December 22, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: December 29, 2022
• First Submitted That Met QC Criteria: January 19, 2023
• First Posted (Actual): January 30, 2023

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: IRB-2021-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No