NCT05704842

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Virtua Health, Inc. · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-12-22
• Primary completion: 2025-12-22
• Completion: 2026-06-01
• First posted: 2023-01-30
• Last updated: 2024-04-05

Locations

1 site across 1 country: United States