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유방암 생존자를 위한 맞춤형 운동 프로그램, STEPS-BC 임상시험 (STEPS-BC)

2026년 10월 2일 업데이트: Wake Forest University Health Sciences

유방암 생존자를 위한 맞춤형 지원 운동 프로그램 (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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

120

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

  • 이름: Karen Craver, MT, MHA
  • 전화번호: 336-716-0891
  • 이메일: NCORP@wfusm.edu

연구 장소

  • 미국
    • North Carolina
      • Winston-Salem, North Carolina, 미국, 27157
        • 모병
        • Wake Forest NCORP RB
        • 연락하다:
        • 연락하다:
      • Winston-Salem, North Carolina, 미국, 27157
        • 모집하지 않고 적극적으로
        • Wake Forest NCORP Research Base
    • Virginia
      • Richmond, Virginia, 미국, 23235
        • 모병
        • VCU Massey Cancer Center at Stony Point
        • 연락하다:
        • 수석 연구원:
          • W. Gregory Hundley, MD
      • Richmond, Virginia, 미국, 23298
        • 모병
        • VCU Massey Comprehensive Cancer Center
        • 연락하다:
        • 수석 연구원:
          • W. Gregory Hundley, MD
        • 연락하다:
          • 전화번호: (804) 628-6430.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 지지 요법
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Arm 1 (PAI+HLI)

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.
절차: Biospecimen Collection

Undergo blood sample collection

다른 이름들:
  • 생물학적 시료 수집, 생물학적 시료 수집, 수집된 생체 시료, 생체 시료 수집, 시료 수집
다른: Questionnaire Administration

Ancillary studies

다른: Exercise Intervention

Attend virtual personalized exercise sessions

다른: Educational Intervention

Attend organized health workshops

다른 이름들:
  • 개입을 위한 교육, 교육에 의한 개입, 교육을 통한 개입, 개입, 교육적
다른: Supportive Care

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

다른 이름들:
  • 지지 치료, 지지 치료, 지지 치료, 지지 치료, 증상 관리, 치료, 지지
절차: Magnetic Resonance Imaging

Undergo CMR

다른 이름들:
  • 자기 공명, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상(MRI)
  • 자기 공명 영상(시술), 자기 공명 영상 검사, 의료 영상, 자기 공명 / 핵 자기 공명, MR, MR, MR 영상, MRI, MRI, MRI, MRI, MRI, MRI
  • MRI 스캔, MRI 스캔, MRI 스캔, MRI 스캔, MRI, NMR 영상, NMRI, NMRI, 핵자기공명영상, 핵자기공명영상, sMRI, 구조적 MRI
절차: Magnetic Resonance Imaging

Undergo ExeCMR

다른 이름들:
  • 자기 공명, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상(MRI)
  • 자기 공명 영상 (시술), 자기 공명 영상 스캔, 의료 영상, 자기 공명 / 핵자기 공명, MR, MR, MR 영상, MRI, MRI, MRI, MRI, MRI, MRI, MRI 스캔
  • MRI 스캔, MRI 스캔, MRI 스캔, MRI, NMR 영상, NMRI, NMRI, 핵자기공명영상, 핵자기공명영상, sMRI, 구조적 MRI
절차: Accelerometry

Ancillary Studies

다른: Electronic Health Record Review

Ancillary Studies

다른: Cardiopulmonary Exercise Testing

Undergo CPET

다른 이름들:
  • CPET, CPX
활성 비교기: Arm 2 (HLI)

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.
절차: Biospecimen Collection

Undergo blood sample collection

다른 이름들:
  • 생물학적 시료 수집, 생물학적 시료 수집, 수집된 생체 시료, 생체 시료 수집, 시료 수집
다른: Questionnaire Administration

Ancillary studies

다른: Educational Intervention

Attend organized health workshops

다른 이름들:
  • 개입을 위한 교육, 교육에 의한 개입, 교육을 통한 개입, 개입, 교육적
다른: Supportive Care

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

다른 이름들:
  • 지지 치료, 지지 치료, 지지 치료, 지지 치료, 증상 관리, 치료, 지지
절차: Magnetic Resonance Imaging

Undergo CMR

다른 이름들:
  • 자기 공명, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상(MRI)
  • 자기 공명 영상(시술), 자기 공명 영상 검사, 의료 영상, 자기 공명 / 핵 자기 공명, MR, MR, MR 영상, MRI, MRI, MRI, MRI, MRI, MRI
  • MRI 스캔, MRI 스캔, MRI 스캔, MRI 스캔, MRI, NMR 영상, NMRI, NMRI, 핵자기공명영상, 핵자기공명영상, sMRI, 구조적 MRI
절차: Magnetic Resonance Imaging

Undergo ExeCMR

다른 이름들:
  • 자기 공명, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상, 자기 공명 영상(MRI)
  • 자기 공명 영상 (시술), 자기 공명 영상 스캔, 의료 영상, 자기 공명 / 핵자기 공명, MR, MR, MR 영상, MRI, MRI, MRI, MRI, MRI, MRI, MRI 스캔
  • MRI 스캔, MRI 스캔, MRI 스캔, MRI, NMR 영상, NMRI, NMRI, 핵자기공명영상, 핵자기공명영상, sMRI, 구조적 MRI
절차: Accelerometry

Ancillary Studies

다른: Electronic Health Record Review

Ancillary Studies

다른: Cardiopulmonary Exercise Testing

Undergo CPET

다른 이름들:
  • CPET, CPX

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Peak oxygen consumption (VO2)
기간: 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.
At baseline and 24 weeks
Left ventricular ejection fraction (LVEF)
기간: 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.
At baseline and 24 weeks

2차 결과 측정

결과 측정
측정값 설명
기간
Ejection Fraction (EF)
기간: At baseline and 12 weeks

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.
At baseline and 12 weeks
6-minute walk test (6MWT) distance
기간: At baseline, 12 weeks, and 24 weeks.

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.
At baseline, 12 weeks, and 24 weeks.
Physical functioning
기간: At baseline, 12 weeks, and 24 weeks

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.
At baseline, 12 weeks, and 24 weeks
Health-related quality of life
기간: At baseline, 12 weeks, and 24 weeks

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.
At baseline, 12 weeks, and 24 weeks
Physical activity and sedentary behavior levels
기간: At baseline, 12 weeks, and 24 weeks

Will be assessed using ActiGraph and ActivPAL accelerometers including mean daily step count. More steps represent more physical activity and less sedentary behavior.
At baseline, 12 weeks, and 24 weeks
Physical activity levels
기간: At baseline, 12 weeks, and 24 weeks

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.
At baseline, 12 weeks, and 24 weeks

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Wake Forest University Health Sciences

수사관

  • 연구 의자: Glenn Lesser, MD, Wake Forest University Health Sciences

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 10월 2일

기본 완료 (추정된)

2030년 4월 30일

연구 완료 (추정된)

2030년 4월 30일

연구 등록 날짜

최초 제출

2026년 3월 11일

QC 기준을 충족하는 최초 제출

2026년 3월 11일

처음 게시됨 (실제)

2026년 3월 16일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 6일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 2일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IRB00144949

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다