Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT05704842

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

Led by Virtua Health, Inc. · Updated on 2024-04-05

40

Participants Needed

1

Research Sites

179 weeks

Total Duration

On this page

Sponsors

V

Virtua Health, Inc.

Lead Sponsor

C

Carevive Systems, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
  • Sufficient vision/hearing or family support
  • Coronary artery disease, if cleared by cardiologist
  • Must have a smartphone, computer, or tablet
  • Willingness to be randomized
Not Eligible

You will not qualify if you...

  • Medical or psychiatric conditions that impair ability to participate (e.g., psychotic disorders, dementia, inability to give informed consent or follow instructions)
  • Patients with overt psychiatric disorders
  • Coronary artery disease not cleared by cardiologist
  • Contraindication to exercise
  • Chronic fatigue syndrome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Virtua Health

Voorhees Township, New Jersey, United States, 08043

Actively Recruiting

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Research Team

S

Susan VanLoon, RN, CCRP

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

FACTORIAL

Primary Purpose

OTHER

Number of Arms

2

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