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New treatment option for Anatomic Stage I Breast Cancer AJCC v8
Official title Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial
ClinicalTrials.gov ID: NCT07474090
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Stage I-III breast cancer (including inflammatory and newly diagnosed, or locally recurrent [if prior treatment received ≥ 2 years prior] but not...
- 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...
- Must be able to complete a stationary bicycle exercise test where you pedal against some resistance on a stationary bike with supervisors at your...
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
You likely can't join 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...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
What rules you out
- 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 treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Winston-Salem, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Winston-Salem, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.