Anatomic Stage I Breast Cancer AJCC v8STEPS-BCNCT07474090
Personalized Exercise Program for Survivors of Breast Cancer, STEPS-BC Trial
A study testing Exercise Intervention, Educational Intervention and Supportive Care in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Wake Forest University Health Sciences at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8
- What is being tested?
- Exercise Intervention, Educational Intervention and Supportive Care
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesUnited States
- Study dates
- 2 Oct 2026to 30 Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Recruiting
VCU Massey Cancer Center at Stony Point
Richmond, Virginia, 23235
ctoclinops@vcu.edu
W. Gregory Hundley, MD
- Recruiting
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, 23298
CTOclinops@vcu.edu
(804) 628-6430.
- Recruiting
Wake Forest NCORP RB
Winston-Salem, North Carolina, 27157
Glenn Lesser, MD, 336-716-0891, ncorp@wfusm.edu
Karen Craver, MHA, 336-716-0891, ncorp@wfusm.edu
- Active, not recruiting
Wake Forest NCORP Research Base
Winston-Salem, North Carolina, 27157
About this study
Official title: Supportive Tailored Exercise Program for Survivors of Breast Cancer (STEPS-BC)
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.
Read the detailed description
PRIMARY OBJECTIVES:
- To determine if a > 10% difference exists in change (i.e., 2.06 ml/kg/min difference) in peak oxygen consumption (VO2) from baseline to 24 weeks after initiating cancer treatment between participants receiving the PAI+HLI versus HLI alone.
II. To determine if a > 10% difference in change in left ventricular ejection fraction (LVEF) from baseline (up to ≤ 4 weeks of chemotherapy initiation) to 24 weeks after initiating cancer treatment exists between participants receiving the PAI+HLI versus HLI alone.
SECONDARY OBJECTIVES:
- To determine if a > 10% difference in change in LVEF from baseline to 12 weeks after initiating cancer treatment exists between participants receiving the PAI+HLI versus HLI alone.
II. To assess changes in 6-minute walk, health-related quality of life (HRQOL), fatigue, strength, physical activity, sedentary and sitting behaviors and physical function between PAI+HLI and HLI alone groups at baseline to 12 \& 24 weeks after initiating cancer treatment.
EXPLORATORY OBJECTIVES:
- We will examine time-dependent changes in traditional and emerging cardiovascular (CV) disease risk factors, including HRQOL, fatigue, chronic psychosocial stress, objectively-assessed physical activity levels, sedentary and sitting behaviors, 6-minute walk distance, self-efficacy for exercise, plasma lipidomics, pro-inflammatory cytokine and fibrosis biomarkers, left ventricular (LV) injury, heart failure (HF), and social determinants of health on exercise capacity and LVEF.
II. In a subset (n=50), we will use innovative measures of magnetic resonance imaging (MRI) exercise-associated cardiac output (ExCO) and LV myocardial fibrosis with and without gadolinium contrast to examine mechanisms underlying exercise intolerance and LV dysfunction.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Within three weeks or less of chemotherapy start date, patients access the Trainerize application (app) and attend two virtual pre-chemotherapy exercise sessions over 10-20 minutes each promoting the importance of staying active across the day and throughout treatment and the identification of limitations and familiarization with different types of exercise. Following chemotherapy initiation, patients attend virtual personalized exercise sessions over 20-60 minutes each and organized health workshops over 40 minutes each once a week (QW) during weeks 1-4, once every 2 weeks (Q2W) during weeks 5-16, and once every 4 weeks (Q4W) during weeks 17-24 in the absence of unacceptable toxicity. 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.
ARM 2: Within three weeks or less of chemotherapy start date, patients attend a virtual pre-chemotherapy organized health workshop over 60 minutes. Following chemotherapy initiation, patients attend virtual organized health workshops over 60 minutes each QW during weeks 1-4, Q2W during weeks 5-16, and Q4W during weeks 17-24. Patients also receive a loaner tablet, if applicable, on study. Additionally, patients undergo blood sample collection, CMR, and CPET on study. Patients may also optionally undergo ExeCMR on study.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Carcinoma, Breast Inflammatory Carcinoma, Locally Recurrent Breast Carcinoma
- Being tested
- Exercise Intervention, Educational Intervention, Supportive Care, Biospecimen Collection, Magnetic Resonance Imaging
- Medical subject headings
- Breast Neoplasms, Inflammatory Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attend virtual personalized exercise sessions
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Attend organized health workshops
Supportive CareOther
Also called Supportive Care, SUPPORTIVE CARE, supportive care, Supportive Therapy, Symptom Management, Therapy, Supportive
Receive Fitbit device, resistance bands, and/or loaner tablet
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection
Undergo blood sample collection
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging, magnetic resonance imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging (MRI), Magnetic Resonance Imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR, MR Imaging, MRI, MRI, MRI, MRI, MRI, MRI, MRI Scan, MRI Scan, MRI Scan, MRI Scan, MRIs, NMR Imaging, NMRI, NMRI, nuclear magnetic resonance imaging,Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Undergo CMR
Magnetic Resonance ImagingProcedure or surgery
Also called Magnetic Resonance, Magnetic Resonance Imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging, magnetic resonance imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR, MR Imaging, MRI, MRI, MRI, MRI, MRI, MRI, MRI Scan, MRI Scan, MRI Scan, MRI Scan, MRIs, NMR Imaging, NMRI, NMRI, nuclear magnetic resonance imaging, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI
Undergo ExeCMR
Questionnaire AdministrationOther
Ancillary studies
AccelerometryProcedure or surgery
Ancillary Studies
Electronic Health Record ReviewOther
Ancillary Studies
Cardiopulmonary Exercise TestingOther
Also called CPET, CPX
Undergo CPET
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (PAI+HLI) | Experimental | Within three weeks or less of chemotherapy start date, patients access the Trainerize app and attend two virtual pre-chemotherapy exercise sessions over 10-20 minutes each promoting the importance of staying active across the day and throughout treatment and the identification of limitations and familiarization with different types of exercise. Following chemotherapy initiation, patients attend virtual personalized exercise sessions over 20-60 minutes each and organized health workshops over 40 minutes each QW during weeks 1-4, Q2W during weeks 5-16, and Q4W during weeks 17-24 in the absence of unacceptable toxicity. Patients also receive a Fitbit device, resistance bands, and a loaner tablet, if applicable, on study. Additionally, patients undergo blood sample collection, CMR, and CPET on study. Patients may also optionally undergo ExeCMR on study. Receives: Other: Exercise Intervention; Other: Educational Intervention; Other: Supportive Care; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Accelerometry; Other: Electronic Health Record Review; Other: Cardiopulmonary Exercise Testing |
| Arm 2 (HLI) | Active comparator | Within three weeks or less of chemotherapy start date, patients attend a virtual pre-chemotherapy organized health workshop over 60 minutes. Following chemotherapy initiation, patients attend virtual organized health workshops over 60 minutes each QW during weeks 1-4, Q2W during weeks 5-16, and Q4W during weeks 17-24. Patients also receive a loaner tablet, if applicable, on study. Additionally, patients undergo blood sample collection, CMR, and CPET on study. Patients may also optionally undergo ExeCMR on study. Receives: Other: Educational Intervention; Other: Supportive Care; Procedure: Biospecimen Collection; Procedure: Magnetic Resonance Imaging; Other: Questionnaire Administration; Procedure: Accelerometry; Other: Electronic Health Record Review; Other: Cardiopulmonary Exercise Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen consumption (VO2)
Will be assessed using cardiopulmonary exercise testing. VO2max, the maximum rate of oxygen consumption measured during incremental exercise, is the gold standard measure of aerobic fitness. It is expressed in milliliters of oxygen consumed per minute per kilogram of body weight (ml/kg/min). Higher VO2max measurements show better function, as it allows one to produce more energy, thereby performing more work.
Measured: At baseline and 24 weeks
Left ventricular ejection fraction (LVEF)
Will be assessed using cardiac magnetic resonance imaging (CMR). Left ventricular ejection fraction (LVEF) typically refers to the left side of the heart. It shows how much oxygen-rich blood is pumped out of the left ventricle to most of the body's organs with each contraction. It a percentage, ranging from 0-100%. LVEF helps determine the severity of dysfunction on the left side of the heart. Higher values of LVEF represent better heart function.
Measured: At baseline and 24 weeks
Secondary outcomes (6)
Ejection Fraction (EF)
Will be assessed using cardiac magnetic resonance imaging (CMR). Ejection fraction measures your heart's ability to pump oxygen-rich blood out to your body. In a healthy heart, this is a higher number. A low number means that your heart has difficulty keeping up with your body's needs. It a percentage, ranging from 0-100%. Higher values of EF represent better heart function.
Measured: At baseline and 12 weeks
6-minute walk test (6MWT) distance
Will be assessed using the Six Minute Walk Test (6MWT). The 6MWT assesses functional exercise capacity, particularly in individuals with cardiopulmonary conditions. The distance walked in 6 minutes on a flat, straight course, typically 30 meters long, is recorded. The distance reflects submaximal (not peak) exercise capacity. The 6MWT is useful for tracking disease progression, assessing rehabilitation outcomes, and evaluating treatment response. Longer distances in meters represents better exercise capacity.
Measured: At baseline, 12 weeks, and 24 weeks.
Physical functioning
Will be assessed using grip strength (GS) and Short Physical Performance Battery (SPPB). The SPPB measures lower-extremity function on a 0-12 point scale (higher is better; ≤9 indicates risk, ≤8 indicates impairment). Grip strength, measured by dynamometer, is measured in kgf with higher values representing more strength.
Measured: At baseline, 12 weeks, and 24 weeks
Health-related quality of life
Will be assessed using the The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) and FACT-Breast. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale is a 13-item, self-reported questionnaire designed to measure fatigue severity and its impact on daily activities over the past 7 days. Scores range from 0 to 52, with higher scores indicating less fatigue (better quality of life). A score of less than 30 typically indicates severe fatigue. The Functional Assessment of Cancer Therapy-Breast (FACT-B) is a 44-item self-report questionnaire designed to measure quality of life in breast cancer patients, with total scores ranging from 0 to 148. It comprises the 27-item FACT-General (FACT-G) and a 10-item Breast Cancer Subscale (BCS), focusing on physical, social, emotional, and functional well-being.
Measured: At baseline, 12 weeks, and 24 weeks
Physical activity and sedentary behavior levels
Will be assessed using ActiGraph and ActivPAL accelerometers including mean daily step count. More steps represent more physical activity and less sedentary behavior.
Measured: At baseline, 12 weeks, and 24 weeks
Physical activity levels
Physical activity levels will be assessed using the Godin Leisure-Time Exercise Questionnaire (GLTEQ), is a 4-item, self-report tool measuring weekly physical activity frequency across three intensities (strenuous, moderate, light) over a 7-day period. It calculates a total leisure score using 9 (strenuous), 5 (moderate), and 3 (light)-with scores typically classifying individuals as active (≥24 units) or insufficiently active (<24 units). Scores range from 0 with no maximum, higher values represent more physical activity during a week.
Measured: At baseline, 12 weeks, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study start2 Oct 2026
- Primary completion30 Apr 2030 (estimated)
- Study completion30 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anatomic Stage I Breast Cancer AJCC v8Studies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- No Data Available
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Glenn Lesser, MD, Study chair, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474090
- Sponsor's protocol ID
- IRB00144949
- Acronym
- STEPS-BC
- Status last verified
- Oct 2026
- First submitted
- 11 Mar 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supportive Tailored Exercise Program for Survivors of Breast Cancer (STEPS-BC)
- ClinicalTrials.gov ID
- NCT07474090
- Acronym / sponsor ID
- STEPS-BC / IRB00144949
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Breast Carcinoma, Breast Inflammatory Carcinoma, Locally Recurrent Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 2 Oct 2026 (actual)
- Primary completion
- 30 Apr 2030 (estimated)
- Study completion
- 30 Apr 2030 (estimated)
- First posted
- 16 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- To determine if a > 10% difference exists in change (i.e., 2.06 ml/kg/min difference) in peak oxygen consumption (VO2) from baseline to 24 weeks after initiating cancer treatment between participants receiving the PAI+HLI versus HLI alone.
II. To determine if a > 10% difference in change in left ventricular ejection fraction (LVEF) from baseline (up to ≤ 4 weeks of chemotherapy initiation) to 24 weeks after initiating cancer treatment exists between participants receiving the PAI+HLI versus HLI alone.
SECONDARY OBJECTIVES:
- To determine if a > 10% difference in change in LVEF from baseline to 12 weeks after initiating cancer treatment exists between participants receiving the PAI+HLI versus HLI alone.
II. To assess changes in 6-minute walk, health-related quality of life (HRQOL), fatigue, strength, physical activity, sedentary and sitting behaviors and physical function between PAI+HLI and HLI alone groups at baseline to 12 \& 24 weeks after initiating cancer treatment.
EXPLORATORY OBJECTIVES:
- We will examine time-dependent changes in traditional and emerging cardiovascular (CV) disease risk factors, including HRQOL, fatigue, chronic psychosocial stress, objectively-assessed physical activity levels, sedentary and sitting behaviors, 6-minute walk distance, self-efficacy for exercise, plasma lipidomics, pro-inflammatory cytokine and fibrosis biomarkers, left ventricular (LV) injury, heart failure (HF), and social determinants of health on exercise capacity and LVEF.
II. In a subset (n=50), we will use innovative measures of magnetic resonance imaging (MRI) exercise-associated cardiac output (ExCO) and LV myocardial fibrosis with and without gadolinium contrast to examine mechanisms underlying exercise intolerance and LV dysfunction.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM 1: Within three weeks or less of chemotherapy start date, patients access the Trainerize application (app) and attend two virtual pre-chemotherapy exercise sessions over 10-20 minutes each promoting the importance of staying active across the day and throughout treatment and the identification of limitations and familiarization with different types of exercise. Following chemotherapy initiation, patients attend virtual personalized exercise sessions over 20-60 minutes each and organized health workshops over 40 minutes each once a week (QW) during weeks 1-4, once every 2 weeks (Q2W) during weeks 5-16, and once every 4 weeks (Q4W) during weeks 17-24 in the absence of unacceptable toxicity. 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.
ARM 2: Within three weeks or less of chemotherapy start date, patients attend a virtual pre-chemotherapy organized health workshop over 60 minutes. Following chemotherapy initiation, patients attend virtual organized health workshops over 60 minutes each QW during weeks 1-4, Q2W during weeks 5-16, and Q4W during weeks 17-24. Patients also receive a loaner tablet, if applicable, on study. Additionally, patients undergo blood sample collection, CMR, and CPET on study. Patients may also optionally undergo ExeCMR on study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- No Data Available
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (PAI+HLI) | Experimental | Other: Exercise Intervention, Other: Educational Intervention, Other: Supportive Care, Procedure: Biospecimen Collection, Procedure: Magnetic Resonance Imaging, Other: Questionnaire Administration, Procedure: Accelerometry, Other: Electronic Health Record Review, Other: Cardiopulmonary Exercise TestingWithin three weeks or less of chemotherapy start date, patients access the Trainerize app and attend two virtual pre-chemotherapy exercise sessions over 10-20 minutes each promoting the importance of staying active across the day and throughout treatment and the identification of limitations and familiarization with different types of exercise. Following chemotherapy initiation, patients attend virtual personalized exercise sessions over 20-60 minutes each and organized health workshops over 40 minutes each QW during weeks 1-4, Q2W during weeks 5-16, and Q4W during weeks 17-24 in the absence of unacceptable toxicity. Patients also receive a Fitbit device, resistance bands, and a loaner tablet, if applicable, on study. Additionally, patients undergo blood sample collection, CMR, and CPET on study. Patients may also optionally undergo ExeCMR on study. |
| Arm 2 (HLI) | Active comparator | Other: Educational Intervention, Other: Supportive Care, Procedure: Biospecimen Collection, Procedure: Magnetic Resonance Imaging, Other: Questionnaire Administration, Procedure: Accelerometry, Other: Electronic Health Record Review, Other: Cardiopulmonary Exercise TestingWithin three weeks or less of chemotherapy start date, patients attend a virtual pre-chemotherapy organized health workshop over 60 minutes. Following chemotherapy initiation, patients attend virtual organized health workshops over 60 minutes each QW during weeks 1-4, Q2W during weeks 5-16, and Q4W during weeks 17-24. Patients also receive a loaner tablet, if applicable, on study. Additionally, patients undergo blood sample collection, CMR, and CPET on study. Patients may also optionally undergo ExeCMR on study. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (22 listed)
- At enrollment, the following diagnosis and/or conditions may not be present (i.e., documented in the medical record or by patient self-report):
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise InterventionAttend virtual personalized exercise sessions | Other | Arm 1 (PAI+HLI) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalAttend organized health workshops | Other | Arm 1 (PAI+HLI), Arm 2 (HLI) |
| Supportive CareAlso: Supportive Care, SUPPORTIVE CARE, supportive care, Supportive Therapy, Symptom Management, Therapy, SupportiveReceive Fitbit device, resistance bands, and/or loaner tablet | Other | Arm 1 (PAI+HLI), Arm 2 (HLI) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen CollectionUndergo blood sample collection | Procedure or surgery | Arm 1 (PAI+HLI), Arm 2 (HLI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging, magnetic resonance imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging (MRI), Magnetic Resonance Imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR, MR Imaging, MRI, MRI, MRI, MRI, MRI, MRI, MRI Scan, MRI Scan, MRI Scan, MRI Scan, MRIs, NMR Imaging, NMRI, NMRI, nuclear magnetic resonance imaging,Nuclear Magnetic Resonance Imaging, sMRI, Structural MRIUndergo CMR | Procedure or surgery | Arm 1 (PAI+HLI), Arm 2 (HLI) |
| Magnetic Resonance ImagingAlso: Magnetic Resonance, Magnetic Resonance Imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging, magnetic resonance imaging, Magnetic Resonance Imaging, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR, MR Imaging, MRI, MRI, MRI, MRI, MRI, MRI, MRI Scan, MRI Scan, MRI Scan, MRI Scan, MRIs, NMR Imaging, NMRI, NMRI, nuclear magnetic resonance imaging, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRIUndergo ExeCMR | Procedure or surgery | Arm 1 (PAI+HLI), Arm 2 (HLI) |
| Questionnaire AdministrationAncillary studies | Other | Arm 1 (PAI+HLI), Arm 2 (HLI) |
| AccelerometryAncillary Studies | Procedure or surgery | Arm 1 (PAI+HLI), Arm 2 (HLI) |
| Electronic Health Record ReviewAncillary Studies | Other | Arm 1 (PAI+HLI), Arm 2 (HLI) |
| Cardiopulmonary Exercise TestingAlso: CPET, CPXUndergo CPET | Other | Arm 1 (PAI+HLI), Arm 2 (HLI) |
Primary outcome
Peak oxygen consumption (VO2)
Time frame: At baseline and 24 weeks
Will be assessed using cardiopulmonary exercise testing. VO2max, the maximum rate of oxygen consumption measured during incremental exercise, is the gold standard measure of aerobic fitness. It is expressed in milliliters of oxygen consumed per minute per kilogram of body weight (ml/kg/min). Higher VO2max measurements show better function, as it allows one to produce more energy, thereby performing more work.
Left ventricular ejection fraction (LVEF)
Time frame: At baseline and 24 weeks
Will be assessed using cardiac magnetic resonance imaging (CMR). Left ventricular ejection fraction (LVEF) typically refers to the left side of the heart. It shows how much oxygen-rich blood is pumped out of the left ventricle to most of the body's organs with each contraction. It a percentage, ranging from 0-100%. LVEF helps determine the severity of dysfunction on the left side of the heart. Higher values of LVEF represent better heart function.
6 secondary outcomes
Ejection Fraction (EF)
Time frame: At baseline and 12 weeks
6-minute walk test (6MWT) distance
Time frame: At baseline, 12 weeks, and 24 weeks.
Physical functioning
Time frame: At baseline, 12 weeks, and 24 weeks
Health-related quality of life
Time frame: At baseline, 12 weeks, and 24 weeks
Physical activity and sedentary behavior levels
Time frame: At baseline, 12 weeks, and 24 weeks
Physical activity levels
Time frame: At baseline, 12 weeks, and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Glenn Lesser, MD study chair
Wake Forest University Health Sciences
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Intervention, Educational Intervention and Supportive Care in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by Wake Forest University Health Sciences at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karen Craver, MT, MHA (336-716-0891, NCORP@wfusm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak oxygen consumption (VO2) (time frame: At baseline and 24 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.