Understanding and Predicting Breast Cancer Events After Treatment (UPBEAT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 403
- 试验地点
- 132
- 主要终点
- Change in FACT-Fatigue Results
研究概览
简要总结
This study is being done to see if patients receiving chemotherapy for breast cancer affects the heart, the ability to exercise and fatigue when compared to patients who do not have cancer.
详细描述
840 women aged ≥18 years old scheduled to receive chemotherapy for Stage I-III breast cancer and a comparison population of 160 women without cancer (1,000 total). Equal numbers of women will be recruited aged < 52 vs. > 52. At baseline, innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers will be collected.
Measurements will be repeated at 3±1, 12±2 and 24±2 months. This study will assess the relevance of pre-existing factors such as age, black/white race, hypertension, smoking (yes/no), diabetes, coronary artery disease, menopause status, CV medications, and physical activity on the study outcomes. Also, this study will assess dynamic change in modifiable CV risk factors (including BMI, blood pressure, serum lipids, serum glucose, physical activity, psychosocial factors, lifestyle behaviors), and the cancer treatment including chemotherapy, radiation therapy, immunotherapy, and surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change in FACT-Fatigue Results
时间窗: Baseline, 3 months, 12 months and 24 months
Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Change in 6 Minute Walk Results
时间窗: Baseline, 3 months, 12 months and 24 months
The purpose of this test is to find out how far the participant can walk in 6 minutes.
FACT-Fatigue
时间窗: Baseline
Participants rate the degree to which each item applies in the past 7 days prior to Baseline using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Change in MRI Exam Results
时间窗: Baseline, 3 months and 24 months
The exam will measure left ventricular volumes, ejection fraction, myocardial strain/strain rate, mass, mapping, aortic pulse wave velocity and aortic wall thickness. The exam will take 10 - 15 minutes to complete.
次要结局
- Cook-Medley Hostility Scale(Baseline)
- Changes in FACT-Fatigue Results(Baseline, 3 months, 12 months, and 24 months)
- 6 Minute Walk Results(Baseline, 3 months, 12 months and 24 months)
- RAND MOS 36-item Short Form Health Survey (SF-36)(Baseline, 3 months, 12 months and 24 months)
- Center for Epidemiological Studies Depression Scale (CESD-10)(Baseline, 3 months, 12 months and 24 months)
- Godin Leisure-Time Exercise Questionnaire (LTEQ)(Baseline, 3 months, 12 months and 24 months)
- PACE Adult Sedentary Behaviors Survey(Baseline, 3 months, 12 months and 24 months)
- PROMIS Short Form 8A Measure of Sleep Disturbance(Baseline, 3 months, 12 months and 24 months)
- Cohen's 4-item Perceived Stress Scale (PSS)(Baseline, 3 months, 12 months, and 24 months)
- PROMIS Applied Cognitive Abilities Short Form 8A and Applied Cognition General Concerns Short Form 8A(Baseline, 3 months, 12 months and 24 months)
- Walking Efficacy for Duration Scale(Baseline, 3 months, 12 months and 24 months)
- Chair Stands - Measures Leg Strength(Baseline, 3 months, 12 months and 24 months)
- Standing Balance Test(Baseline, 3 months, 12 months and 24 months)
- Gait Speed Test(Baseline, 3 months, 12 months and 24 months)
- Grip Strength(Baseline, 3 months, 12 months and 24 months)
- Range of Motion(Baseline, 3 months, 12 months and 24 months)
- KCCQ-12 Questionnaire(Baseline, 24 months)
- Cohen's 4-item Perceived Stress Scale (PSS)(Baseline, 3 months, 12 months, and 24 months)
- Cook-Medley Hostility Scale(Baseline)
- Changes in FACT-Fatigue Results(Baseline, 3 months, 12 months, and 24 months)
- 6 Minute Walk Results(Baseline, 3 months, 12 months and 24 months)
- RAND MOS 36-item Short Form Health Survey (SF-36)(Baseline, 3 months, 12 months and 24 months)
- Center for Epidemiological Studies Depression Scale (CESD-10)(Baseline, 3 months, 12 months and 24 months)
- Godin Leisure-Time Exercise Questionnaire (LTEQ)(Baseline, 3 months, 12 months and 24 months)
- PACE Adult Sedentary Behaviors Survey(Baseline, 3 months, 12 months and 24 months)
- PROMIS Short Form 8A Measure of Sleep Disturbance(Baseline, 3 months, 12 months and 24 months)
- PROMIS Applied Cognitive Abilities Short Form 8A and Applied Cognition General Concerns Short Form 8A(Baseline, 3 months, 12 months and 24 months)
- Walking Efficacy for Duration Scale(Baseline, 3 months, 12 months and 24 months)
- Chair Stands - Measures Leg Strength(Baseline, 3 months, 12 months and 24 months)
- Standing Balance Test(Baseline, 3 months, 12 months and 24 months)
- Gait Speed Test(Baseline, 3 months, 12 months and 24 months)
- Grip Strength(Baseline, 3 months, 12 months and 24 months)
- Range of Motion(Baseline, 3 months, 12 months and 24 months)
- KCCQ-12 Questionnaire(Baseline, 24 months)