RecruitingNot applicable

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

Supportive Tailored Exercise Program for Survivors of Breast Cancer (STEPS-BC)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 85 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills, Blood draws, MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients also receive a Fitbit device, resistance bands, and a loaner tablet, if applicable, on study."
  • "Additionally, patients undergo blood sample collection, cardiovascular magnetic resonance imaging (CMR), and cardiopulmonary exercise testing (CPET) on study."
  • "Patients may also optionally undergo exercise cardiovascular magnetic resonance imaging (ExeCMR) on study."
  • "Patients also receive a loaner tablet, if applicable, on study."
  • "Additionally, patients undergo blood sample collection, CMR, and CPET on study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether online healthy living classes, with or without a personal exercise program, help protect exercise ability, heart health, and quality of life during chemotherapy. It is for adults ages 18 to 85 with stage I–III breast cancer who are scheduled to receive chemotherapy.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have stage I–III breast cancer being treated with the goal of a cure. All tumor types are allowed, including inflammatory breast cancer. If cancer has returned nearby, prior treatment must have been at least 2 years ago.
  • Be scheduled for chemotherapy before or after surgery, and join the study within 3 weeks of starting chemotherapy.
  • Be 18 to 85 years old.
  • Be able to care for yourself and be up and moving for at least half of your waking hours.
  • Be able to do a supervised exercise test on a stationary bike with some resistance.
  • Be able to walk at least 2 blocks without chest pain, trouble breathing, or fainting, and hold your breath for 8 seconds.
  • Be able to read and understand English.
  • Have a device for video calls and be willing to use the Trainerize app, or use the study's tablet loan program. Have a working email address; staff can help set one up.

Who can't join

  • Be pregnant or breastfeeding, have symptoms from fear of tight spaces, or have metal or implanted devices that are not safe for an MRI scan.
  • Have blood pressure above 190 for the top number or 100 for the bottom number, an inflammatory illness such as lupus or inflammatory bowel disease, or another condition your doctor thinks could make participation unsafe or difficult.
  • Have certain heart problems: serious or uncontrolled heart rhythms, heart-related chest pain, heart failure with symptoms, severe valve disease, disease of the heart's left main artery, or thickened heart muscle that blocks blood flow.
  • Have severe high blood pressure in the lungs, a tear in the body's main artery, or a bulge in that artery wider than 45 millimeters.
  • Have had a heart attack within 28 days, or a blood clot in a lung or deep vein within 24 weeks before joining.
  • Plan to move within 6 months and be unable to complete study activities.
  • Be in another study testing supportive care, or be receiving treatment for a second cancer at the same time. Past cancer is allowed if chemotherapy was at least 2 years ago.
  • Already do 300 minutes or more of moderate to hard physical activity each week.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (4)

NC

VA