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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise Intervention

    Other intervention

    Attend virtual personalized exercise sessions

  • Educational Intervention

    Other intervention

    Attend organized health workshops

  • Supportive Care

    Other intervention

    Receive Fitbit device, resistance bands, and/or loaner tablet

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood sample collection

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo CMR

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo ExeCMR

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Accelerometry

    Procedure/Surgery

    Ancillary Studies

  • Electronic Health Record Review

    Other intervention

    Ancillary Studies

  • Cardiopulmonary Exercise Testing

    Other intervention

    Undergo CPET

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Arm 1 (PAI+HLI)Experimental treatment 9 interventions
Group B: Arm 2 (HLI)Active comparator 8 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At baseline and 24 weeks
2

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.

Time frame
At baseline and 24 weeks

Secondary outcomes

1

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.

Time frame
At baseline and 12 weeks
2

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.

Time frame
At baseline, 12 weeks, and 24 weeks.
3

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.

Time frame
At baseline, 12 weeks, and 24 weeks
4

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.

Time frame
At baseline, 12 weeks, and 24 weeks

Other outcomes

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