Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial (NCT07474090) | Clinical Trial Compass
RecruitingNot Applicable
Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial
United States120 participantsStarted 2026-05-27
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 Pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.