Trials / Not Yet Recruiting

Not Yet RecruitingNCT07474090

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

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

Status: Not Yet Recruiting
Phase: N/A
Study type: Interventional
Enrollment: 120 (estimated)

Sponsor: Wake Forest University Health Sciences · Academic / Other
Sex: All
Age: 18 Years – 85 Years
Healthy volunteers: Not accepted

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.

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.

Conditions

Interventions

Type	Name	Description
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

Timeline

Start date: 2026-07-05
Primary completion: 2029-09-01
Completion: 2030-01-31
First posted: 2026-03-16
Last updated: 2026-03-16

Source: ClinicalTrials.gov record NCT07474090. Inclusion in this directory is not an endorsement.