乳腺癌幸存者个性化锻炼计划，STEPS-BC试验 (STEPS-BC)
乳腺癌幸存者支持性量身定制锻炼计划（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.
研究概览
地位
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Karen Craver, MT, MHA
- 电话号码：336-716-0891
- 邮箱：NCORP@wfusm.edu
学习地点
-
-
North Carolina
-
Winston-Salem、North Carolina、美国、27157
- 招聘中
- Wake Forest NCORP RB
-
接触：
- Glenn Lesser, MD
- 电话号码：336-716-0891
- 邮箱：ncorp@wfusm.edu
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接触：
- Karen Craver, MHA
- 电话号码：336-716-0891
- 邮箱：ncorp@wfusm.edu
-
Winston-Salem、North Carolina、美国、27157
- 主动，不招人
- Wake Forest NCORP Research Base
-
-
Virginia
-
Richmond、Virginia、美国、23235
- 招聘中
- VCU Massey Cancer Center at Stony Point
-
接触：
-
首席研究员：
- W. Gregory Hundley, MD
-
Richmond、Virginia、美国、23298
- 招聘中
- VCU Massey Comprehensive Cancer Center
-
接触：
-
首席研究员：
- W. Gregory Hundley, MD
-
接触：
- 电话号码：(804) 628-6430.
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
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Acute myocardial infarction within 28 days of enrollment
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Acute pulmonary embolus and/or deep vein thrombosis within 24 weeks prior to enrollment
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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
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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)
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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
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：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. |
Undergo blood sample collection
其他名称：
Ancillary studies Attend virtual personalized exercise sessions Attend organized health workshops
其他名称：
Receive Fitbit device, resistance bands, and/or loaner tablet
其他名称：
Undergo CMR
其他名称：
Undergo ExeCMR
其他名称：
Ancillary Studies Ancillary Studies Undergo CPET
其他名称：
|
|
有源比较器：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. |
Undergo blood sample collection
其他名称：
Ancillary studies Attend organized health workshops
其他名称：
Receive Fitbit device, resistance bands, and/or loaner tablet
其他名称：
Undergo CMR
其他名称：
Undergo ExeCMR
其他名称：
Ancillary Studies Ancillary Studies Undergo CPET
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Peak oxygen consumption (VO2)
大体时间：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)
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Ejection Fraction (EF)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
合作者和调查者
调查人员
- 学习椅：Glenn Lesser, MD、Wake Forest University Health Sciences
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IRB00144949
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