Clinical trial NCT05704842: Evaluate Impact of Exercise Program on Fatigue in Breast Cancer During Chemotherapy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Virtua Health, Inc.
Sponsor class: OTHER
Collaborators: name: Carevive Systems, Inc.
First posted: 2023-01-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
timeFrame: Baseline
measure: Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
timeFrame: Weekly for 12 weeks
measure: Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
timeFrame: Month 1 following completion of chemotherapy
measure: Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
timeFrame: Month 3 following completion of chemotherapy
measure: Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.
timeFrame: Month 6 following completion of chemotherapy
Secondary outcomes:
measure: To quantify the change over time in PRO-CTCAE derived symptoms
timeFrame: Baseline
measure: To quantify the change over time in PRO-CTCAE derived symptoms
timeFrame: Weekly for 12 weeks
measure: To quantify the change over time in PRO-CTCAE derived symptoms
timeFrame: Month 1 following completion of chemotherapy
measure: To quantify the change over time in PRO-CTCAE derived symptoms
timeFrame: Month 3 following completion of chemotherapy
measure: To quantify the change over time in PRO-CTCAE derived symptoms
timeFrame: Month 6 following completion of chemotherapy
Other outcomes:
Locations:
city: Voorhees
country: United States
facility: Virtua Health
state: New Jersey
Study officials:
affiliation: Penn Medicine
name: Priya P Gor, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: