Recruiting

Exercise Program

Sponsor:

Virtua Health, Inc.

Code:

NCT05704842

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Exercise

Study Details

Brief 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.

Conditions

Breast Cancer

Study ID

NCT05704842

Start date

Dec 22, 2022

Status verified date

Apr, 2024

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Dec 22, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not 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.

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Exercise

Intervention: Subject will be assessed by a Physical Therapist. Based on the assessment, the Physical Therapist will provide the patient with a home-based exercise program including core exercises as follows: Core Stabilization, core extension, leg extensions, squats with and without weights, shoulder and arm exercises. Patients will be asked to complete a symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.

no intervention: Control

Subject will not be provided an exercise program but will be asked to complete the symptom survey weekly via a web-based platform for tracking cancer and treatment-related symptoms and fatigue.

Interventions

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.

Primary outcome measure

  • Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. [ Time Frame: Baseline ]
  • Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. [ Time Frame: Weekly for 12 weeks ]
  • Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. [ Time Frame: Month 1 following completion of chemotherapy ]
  • Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. [ Time Frame: Month 3 following completion of chemotherapy ]
  • Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue. [ Time Frame: Month 6 following completion of chemotherapy ]

Central Contacts and Locations

Central contacts

Susan VanLoon, RN, CCRP

8562477382svanloon@virtua.org

Locations

Virtua Health

Recruiting

Voorhees, New Jersey, United States, 08043

Contacts

Susan VanLoon, RN, CCRP

856-247-7382svanloon@virtua.org

More Information

Sponsor

Virtua Health, Inc.

Last update posted

Apr 5, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virtua Health, Inc. on 2024-04-05.