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

NCT05704842 | Recruiting

• 1 other identifier: IRB-2021-04
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.

  The outcome will be measured by using the FACIT Fatigue Scale 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).

  Baseline

• Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.

  Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).

  Weekly for 12 weeks

• Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.

  Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).

  Month 1 following completion of chemotherapy

• Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.

  Changes in fatigue will be assessed, this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).

  Month 3 following completion of chemotherapy

• Determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue.

  Changes in fatigue will be assessed this outcome will be measured by using the FACIT Fatigue Scale, 0 - 4. 0 = (not at all) 1= (a little bit) 2 = (somewhat) 3 = (Quite a bit), 4 = (Very much).

  Month 6 following completion of chemotherapy

Secondary Outcomes (5)

• To quantify the change over time in PRO-CTCAE derived symptoms

  Baseline

• To quantify the change over time in PRO-CTCAE derived symptoms

  Weekly for 12 weeks

• To quantify the change over time in PRO-CTCAE derived symptoms

  Month 1 following completion of chemotherapy

• To quantify the change over time in PRO-CTCAE derived symptoms

  Month 3 following completion of chemotherapy

• To quantify the change over time in PRO-CTCAE derived symptoms

  Month 6 following completion of chemotherapy

Study Arms (2)

Exercise

OTHER

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.

Behavioral: Exercise

Control

NO INTERVENTION

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 BEHAVIORAL

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

Also known as: Exercise program

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Virtua Health, Inc.: lead
• Carevive Systems, Inc.: collaborator

Study Sites (1)

Virtua Health

Voorhees Township, New Jersey, 08043, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Exercise; Resistance Training

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human

Study Officials

• Priya P Gor, MD, MSCE

  Penn Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Susan VanLoon, RN, CCRP

CONTACT

8562477382; svanloon@virtua.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 30, 2023
• Study Start: December 22, 2022
• Primary Completion: December 22, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)