RecruitingNot ApplicableNCT05704842

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

Sponsor

Virtua Health, Inc.

Enrollment

40 participants

Start Date

Dec 22, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria8

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 Criteria5

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.

Interventions

BEHAVIORALExercise

Home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises.