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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05704842
• Other study ID #: IRB-2021-04
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2022
• Est. completion date: June 1, 2026

Study information

• Verified date: April 2024
• Source: Virtua Health, Inc.
• Contact: Susan VanLoon, RN, CCRP
• Phone: 8562477382
• Email: svanloon[@]virtua.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2026
• Est. primary completion date: December 22, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Virtua Health	Voorhees	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Virtua Health, Inc.	Carevive Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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