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Trial Title:
Evaluate Impact of Exercise Program on Fatigue in Breast Cancer During Chemotherapy
NCT ID:
NCT05704842
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Factorial Assignment
Primary purpose:
Other
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Exercise
Description:
Home-based exercise program including core exercises as follows: Core Stabilization, core
extension, leg extensions, squats with and without weights, shoulder and arm exercises.
Arm group label:
Exercise
Other name:
Exercise program
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
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Virtua Health
Address:
City:
Voorhees
Zip:
08043
Country:
United States
Status:
Recruiting
Contact:
Last name:
Susan VanLoon, RN, CCRP
Phone:
856-247-7382
Email:
svanloon@virtua.org
Start date:
December 22, 2022
Completion date:
June 1, 2026
Lead sponsor:
Agency:
Virtua Health, Inc.
Agency class:
Other
Collaborator:
Agency:
Carevive Systems, Inc.
Agency class:
Industry
Source:
Virtua Health, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05704842
