NCT00869466已完成不适用
B- AHEAD Study (Breast - Activity & Healthy Eating After Diagnosis) Randomised Comparison of 3 Weight Control Programmes During Adjuvant Treatment for Early Breast Cancer.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 409
- 试验地点
- 5
- 主要终点
- Changes in body weight and composition (i.e., body fat, fat-free mass, dual energy x-ray absorptiometry, bioelectrical impedance, and waist and hip circumference) at baseline and at 6 and 12 months
研究概览
简要总结
RATIONALE: Measuring changes in body weight and body composition in women with early-stage breast cancer may help doctors plan the best weight control program and improve patients' quality of life. It is not yet known which program is most effective in women with breast cancer.
PURPOSE: This randomized clinical trial is comparing three weight control programs to see how well they work in women who have undergone surgery for early stage breast cancer.
详细描述
OBJECTIVES:
Primary
- To assess changes in body weight and composition (i.e., body fat, fat-free mass, dual energy x-ray absorptiometry, bioelectrical impedance, and waist and hip circumference) in patients with early stage breast cancer.
Secondary
- To assess uptake and retention to the interventions and adverse effects of the interventions in these patients.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Changes in body weight and composition (i.e., body fat, fat-free mass, dual energy x-ray absorptiometry, bioelectrical impedance, and waist and hip circumference) at baseline and at 6 and 12 months
次要结局
- Changes in insulin resistance and glucose homeostasis model assessment (HOMA) at baseline and at 6 and 12 months
- Changes in serum bone markers/bone specific alkaline phosphatase for bone formation and the cross linked C-telopeptides of type I collagen for bone resorption at baseline and at 6 and 12 months
- Changes in generic health status and quality of life (as assessed by EQ-5D utility measure) and health resource usage to assess the relative cost effectiveness of the interventions at baseline and at 3, 6, and 12 months
- Uptake and retention of information about the interventions and adverse effects of the interventions
- Changes in dietary intake (as assessed by a 7-day food diary) and activity (as assessed by a 7-day activity diary) as measures of compliance at baseline and at 6 and 12 months
- Patient experience of interventions through in-depth focus group discussions and individual interviews
- Changes in markers of breast cancer prognosis at baseline and at 6 and 12 months
- Changes in arm mobility, function (as assessed by quick DASH), and pain (as assessed by pain rating scale and S-LANSS for neuropathic pain) at baseline and at 6 and 12 months
- Changes in quality of life as assessed by FACT-B, B-ES, and -F at baseline and at 6 and 12 months
- Changes in ipsilateral arm circumference (compared to contralateral arm) using perometer in patients having axillary node clearance at baseline and at 6 and 12 months
- Changes in isometric and isokinetic muscle strength of quadriceps in patients receiving aromatase inhibitors and age-matched patients receiving tamoxifen in a subset of patients in the standard written only group
- Factors predicting adherence to interventions with scales of stage of behavior change for weight control and exercise
- Cardiovascular disease-risk markers (i.e., total LDL and HDL cholesterol, triglycerides, and systolic/diastolic blood pressure) at baseline and at 6 and 12 months
- Changes in fitness as assessed by a 12-minute walk test at baseline and at 6 and 12 months
研究者
研究点 (5)
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