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

RECRUITINGN/ASponsored by Virtua Health, Inc.
Actively Recruiting
PhaseN/A
SponsorVirtua Health, Inc.
Started2022-12-22
Est. completion2025-12-22
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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.

Conditions2

Breast CancerCancer

Locations1 site

Virtua Health
Voorhees Township, New Jersey, 08043
Susan VanLoon, RN, CCRP856-247-7382svanloon@virtua.org

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