Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial

NCT07474090 | Active Not Recruiting DMC

• 1 other identifier: IRB00144949
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies whether a healthy living intervention (HLI), with or without a physical activity intervention (PAI), helps maintain the ability to exercise, heart health, and quality of life in breast cancer patients who are scheduled to receive chemotherapy treatment. Early detection and enhanced therapies for breast cancer have improved 5-year cancer-related survival rates. Unfortunately, many breast cancer survivors are at high risk for long-term exercise intolerance, decreased heart health, and lower quality of life following chemotherapy. Currently, there are no effective therapies to help patients maintain these areas throughout chemotherapy. The HLI in this study includes virtual health education classes, which provide useful information on topics like proper nutrition, managing stress, and sleep practices. This may help patients understand the importance of living a healthy lifestyle during chemotherapy. The PAI in this study consists of virtual exercise sessions personalized to the needs of the patient, which may make it easier for patients to stay active during chemotherapy. HLI with PAI may be a more effective way to help maintain ability to exercise, heart health, and quality of life in breast cancer patients who are scheduled to receive chemotherapy treatment.

Conditions

Anatomic Stage I Breast Cancer AJCC v8; Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage III Breast Cancer AJCC v8; Breast Carcinoma; Breast Inflammatory Carcinoma; Locally Recurrent Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• Peak oxygen consumption (VO2)

  Will be assessed using cardiopulmonary exercise testing. VO2max, the maximum rate of oxygen consumption measured during incremental exercise, is the gold standard measure of aerobic fitness. It is expressed in milliliters of oxygen consumed per minute per kilogram of body weight (ml/kg/min). Higher VO2max measurements show better function, as it allows one to produce more energy, thereby performing more work.

  At baseline and 24 weeks

• Left ventricular ejection fraction (LVEF)

  Will be assessed using cardiac magnetic resonance imaging (CMR). Left ventricular ejection fraction (LVEF) typically refers to the left side of the heart. It shows how much oxygen-rich blood is pumped out of the left ventricle to most of the body's organs with each contraction. It a percentage, ranging from 0-100%. LVEF helps determine the severity of dysfunction on the left side of the heart. Higher values of LVEF represent better heart function.

  At baseline and 24 weeks

Secondary Outcomes (6)

• Ejection Fraction (EF)

  At baseline and 12 weeks

• 6-minute walk test (6MWT) distance

  At baseline, 12 weeks, and 24 weeks.

• Physical functioning

  At baseline, 12 weeks, and 24 weeks

• Health-related quality of life

  At baseline, 12 weeks, and 24 weeks

• Physical activity and sedentary behavior levels

  At baseline, 12 weeks, and 24 weeks

Study Arms (2)

Arm 1 (PAI+HLI)

EXPERIMENTAL

Within three weeks or less of chemotherapy start date, patients access the Trainerize app and attend two virtual pre-chemotherapy exercise sessions over 10-20 minutes each promoting the importance of staying active across the day and throughout treatment and the identification of limitations and familiarization with different types of exercise. Following chemotherapy initiation, patients attend virtual personalized exercise sessions over 20-60 minutes each and organized health workshops over 40 minutes each QW during weeks 1-4, Q2W during weeks 5-16, and Q4W during weeks 17-24 in the absence of unacceptable toxicity. Patients also receive a Fitbit device, resistance bands, and a loaner tablet, if applicable, on study. Additionally, patients undergo blood sample collection, CMR, and CPET on study. Patients may also optionally undergo ExeCMR on study.

Other: Exercise Intervention; Other: Educational Intervention; Other: Supportive Care; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Accelerometry; Other: Electronic Health Record Review; Other: Cardiopulmonary Exercise Testing

Arm 2 (HLI)

ACTIVE COMPARATOR

Within three weeks or less of chemotherapy start date, patients attend a virtual pre-chemotherapy organized health workshop over 60 minutes. Following chemotherapy initiation, patients attend virtual organized health workshops over 60 minutes each QW during weeks 1-4, Q2W during weeks 5-16, and Q4W during weeks 17-24. Patients also receive a loaner tablet, if applicable, on study. Additionally, patients undergo blood sample collection, CMR, and CPET on study. Patients may also optionally undergo ExeCMR on study.

Other: Educational Intervention; Other: Supportive Care; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Accelerometry; Other: Electronic Health Record Review; Other: Cardiopulmonary Exercise Testing

Interventions

Electronic Health Record Review OTHER

Ancillary Studies

Arm 1 (PAI+HLI); Arm 2 (HLI)

Cardiopulmonary Exercise Testing OTHER

Undergo CPET

Also known as: CPET, CPX

Arm 1 (PAI+HLI); Arm 2 (HLI)

Exercise Intervention OTHER

Attend virtual personalized exercise sessions

Arm 1 (PAI+HLI)

Educational Intervention OTHER

Attend organized health workshops

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm 1 (PAI+HLI); Arm 2 (HLI)

Supportive Care OTHER

Receive Fitbit device, resistance bands, and/or loaner tablet

Also known as: Supportive Care, SUPPORTIVE CARE, supportive care, Supportive Therapy, Symptom Management, Therapy, Supportive

Arm 1 (PAI+HLI); Arm 2 (HLI)

Accelerometry PROCEDURE

Ancillary Studies

Arm 1 (PAI+HLI); Arm 2 (HLI)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection

Arm 1 (PAI+HLI); Arm 2 (HLI)

Magnetic Resonance Imaging PROCEDURE

Undergo CMR

Also known as: Magnetic Resonance, Magnetic Resonance Imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging, magnetic resonance imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging (MRI), Magnetic Resonance Imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR, MR Imaging, MRI, MRI, MRI, MRI, MRI, MRI, MRI Scan, MRI Scan, MRI Scan, MRI Scan, MRIs, NMR Imaging, NMRI, NMRI, nuclear magnetic resonance imaging,Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Arm 1 (PAI+HLI); Arm 2 (HLI)

Questionnaire Administration OTHER

Ancillary studies

Arm 1 (PAI+HLI); Arm 2 (HLI)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage I-III breast cancer (including inflammatory and newly diagnosed, or locally recurrent \[if prior treatment received ≥ 2 years prior\] but not metastatic breast cancer being treated with curative intent). All molecular subtypes (estrogen receptor \[ER\], progesterone receptor \[PR\], human epidermal growth factor receptor 2 \[HER2\], etc.) are acceptable
• Scheduled to receive neoadjuvant or adjuvant cytotoxic chemotherapy. Patient must be enrolled ≤ 3 weeks from start of cytotoxic chemotherapy
• Age 18 to 85 years at enrollment. The upper age cut-off is due to the increased risk of injury in the older population during the CPET, which uses stationary bicycle exercise testing, outweighing the benefit of including this age group
• Must be able to complete a stationary bicycle exercise test where you pedal against some resistance on a stationary bike with supervisors at your side per patient self-report
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
• Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting per patient self-report
• Able to hold breath for 8 seconds
• Must be able to read and understand English language
• Must have access to a device that allows teleconferencing (e.g., Zoom calls) or be willing to participate in the Tablet Lending Program
• Must be willing to download and use the Trainerize application to their personal device or be willing to participate in the Tablet Lending Program
• Must have a working email address to participate in teleconferencing (e.g., Zoom calls). Local National Cancer Institute Community Oncology Research Program (NCORP) site staff may assist in setting up a new email address, if needed

You may not qualify if:

• At enrollment, the following diagnosis and/or conditions may not be present (i.e., documented in the medical record or by patient self-report):
• Symptomatic claustrophobia
• Pregnancy or breast-feeding
• Ferromagnetic cerebral aneurysm clips or other intraorbital/intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices, such as tissue expanders
• Uncontrolled hypertension (systolic blood pressure \> 190 mm Hg or diastolic blood pressure \> 100 mm Hg)
• Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion, as determined by the treating physician
• Significant ventricular arrhythmias (\> 20 premature ventricular contractions \[PVCs\]/min)
• Atrial fibrillation with uncontrolled ventricular response (\> 130 beats per minute \[bpm\])
• Unstable or stable angina (cardiac chest pain)
• Severe pulmonary hypertension
• Left main coronary artery disease
• Symptomatic heart failure
• Severe valvular heart disease
• Aortic aneurysm (\> 45 mm diameter) or aortic dissection
• Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest NCORP Research Base

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Palliative Care; Therapeutics; Specimen Handling; Magnetic Resonance Spectroscopy; X-Rays; Accelerometry; Exercise Test; Clostridium perfringens epsilon-toxin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Patient Care; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry

Study Officials

• Glenn Lesser, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All study team members will be blinded to the results of the lipid-related biomarkers until the end of the study to avoid any potential bias. All images will be processed offline by an image analyst blinded to study group.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: No Data Available

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 16, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): April 30, 2030
• Study Completion (Estimated): April 30, 2030
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

US (1)