Personalized Exercise Plan for Breast Cancer Survivors on Chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares two approaches for patients with Stage I–III breast cancer who are about to start chemotherapy. Participants receive either a physical activity plus healthy-living education program or the healthy-living education program alone, both delivered with virtual components. The study measures changes in peak oxygen use (VO2 max) and heart function, along with secondary outcomes like walking ability, fatigue, quality of life, and physical activity over 12 to 24 weeks. Additional exploratory analyses will look at biomarkers and other cardiovascular risk factors. Interventions include exercise sessions, educational content, supportive care, and biospecimen collection with MRI assessments at specified times.

Why it matters

Who can join: the full rules

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

Where it's running

• Wake Forest NCORP RB
  Winston-Salem, North Carolina, United States Recruiting
• VCU Massey Cancer Center at Stony Point
  Richmond, Virginia, United States Recruiting
• VCU Massey Comprehensive Cancer Center
  Richmond, Virginia, United States Recruiting
• Wake Forest NCORP Research Base
  Winston-Salem, North Carolina, United States Active not recruiting

Study contacts

• Study coordinator: Karen Craver, MT, MHA
• Email: NCORP@wfusm.edu
• Phone: 336-716-0891

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.