RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot Study to Evaluate the Impact of a Home-Based Exercise Program on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Curative-Intent Chemotherapy

Quick Facts

Study Start:2022-12-22
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05704842

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women with curative-intent breast cancer who plan to undergo at least 4 cycles of chemotherapy.
  2. * Age \> 18 years
  3. * ECOG performance score \< 3
  4. * English-speaking
  5. * with sufficient vision/hearing or family support
  6. * Coronary artery disease, if cleared by cardiologist
  7. * Subject must have smart phone, computer or tablet.
  8. * Willingness to be randomized
  1. * 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).
  2. * Patients with overt evidence of a psychiatric disorder.
  3. * Coronary artery disease, not cleared by cardiologist.
  4. * Contraindication to exercise.
  5. * Chronic fatigue syndrome.

Contacts and Locations

Study Contact

Susan VanLoon, RN, CCRP
CONTACT
8562477382
svanloon@virtua.org

Principal Investigator

Priya P Gor, MD, MSCE
PRINCIPAL_INVESTIGATOR
Penn Medicine

Study Locations (Sites)

Virtua Health
Voorhees, New Jersey, 08043
United States

Collaborators and Investigators

Sponsor: Virtua Health, Inc.

  • Priya P Gor, MD, MSCE, PRINCIPAL_INVESTIGATOR, Penn Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-12-22
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2022-12-22
Study Completion Date2026-06-01

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Cancer