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

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