RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Wake Forest University Health Sciences • ClinicalTrials.gov ID: NCT07474090

Registry updated: 2026-10-06

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Description

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.

Interventions

Exercise Intervention (Other)
Attend virtual personalized exercise sessions
Educational Intervention (Other)
Attend organized health workshops
Supportive Care (Other)
Receive Fitbit device, resistance bands, and/or loaner tablet
Biospecimen Collection (Procedure)
Undergo blood sample collection
Magnetic Resonance Imaging (Procedure)
Undergo CMR
Magnetic Resonance Imaging (Procedure)
Undergo ExeCMR
Questionnaire Administration (Other)
Ancillary studies
Accelerometry (Procedure)
Ancillary Studies
Electronic Health Record Review (Other)
Ancillary Studies
Cardiopulmonary Exercise Testing (Other)
Undergo CPET

Eligibility criteria

Inclusion Criteria: * 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 Exclusion Criteria: * 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 * Hypertrophic obstructive cardiomyopathy * Acute myocardial infarction within 28 days of enrollment * Acute pulmonary embolus and/or deep vein thrombosis within 24 weeks prior to enrollment * Plans to relocate within 6 months of enrollment and unable to participate in study procedures * May not be on a simultaneous interventional supportive care (non-therapeutic) clinical trial * May not be undergoing simultaneous treatment for a concurrent second primary cancer (patients with historical cancer will not be excluded if chemotherapy was received ≥ 2 years prior) * May not be currently engaged in ≥ 300 minutes of moderate to vigorous intensity physical activity per week as determined by self-report on the International Physical Activity Questionnaire -Short Form (IPAQ-SF). Site should use the IPAQ-SF screener in the REDCap WF-2401 STEPS-BC screening project to assist in this determination

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

Locations

Wake Forest NCORP RB — Winston-Salem, North Carolina, United States
Wake Forest NCORP Research Base — Winston-Salem, North Carolina, United States
VCU Massey Cancer Center at Stony Point — Richmond, Virginia, United States
VCU Massey Comprehensive Cancer Center — Richmond, Virginia, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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