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

Official title

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

Overview

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:

I. 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:

I. 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:

I. 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.

Interventions

• Other Exercise Intervention
  Attend virtual personalized exercise sessions
• Other Educational Intervention
  Attend organized health workshops
• Other Supportive Care
  Receive Fitbit device, resistance bands, and/or loaner tablet
• Procedure Biospecimen Collection
  Undergo blood sample collection
• Procedure Magnetic Resonance Imaging
  Undergo CMR
• Procedure Magnetic Resonance Imaging
  Undergo ExeCMR
• Other Questionnaire Administration
  Ancillary studies
• Procedure Accelerometry
  Ancillary Studies
• Other Electronic Health Record Review
  Ancillary Studies
• Other Cardiopulmonary Exercise Testing
  Undergo CPET

Primary outcome measures

• Peak oxygen consumption (VO2) [Time frame: At baseline and 24 weeks]
• Left ventricular ejection fraction (LVEF) [Time frame: At baseline and 24 weeks]

Secondary outcome measures (6)

• 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Wake Forest NCORP RB — Winston-Salem
• Wake Forest NCORP Research Base — Winston-Salem

Identifiers

NCT: NCT07474090 · IRB00144949

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗