NCT00037024已完成不适用
Project LEAD: Promoting Health Among Populations With Early Stage Cancers
Duke University2 个研究点 分布在 1 个国家开始时间: 2002年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 试验地点
- 2
研究概览
简要总结
RATIONALE: Telephone counseling by a nutritionist and a personal trainer may improve physical function and quality of life in patients who have early-stage breast cancer or prostate cancer.
PURPOSE: Randomized clinical trial to compare the effectiveness of a home-based, diet and exercise-based counseling program with that of a standard home-based counseling program in promoting health in patients who have early-stage breast cancer or prostate cancer.
详细描述
OBJECTIVES:
- Compare the efficacy of a diet and exercise-based home-based counseling program versus a standard home-based counseling program for improving physical function at 6 and 12 months for patients with early-stage breast or prostate cancer.
- Compare the effects of these home-based programs on diet quality, physical activity, weight status, depression, and quality of life of these patients.
- Compare the factors, such as gender, race, and social support, that interact with these home-based programs to predict program efficacy in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.
- Arm I: Patients receive home-based telephone counseling by a personal nutritionist and a personal trainer.
- Arm II: Patients receive home-based standard health telephone counseling in unrelated areas of cancer care (e.g., sun exposure, screening, and falls prevention).
In both arms, counseling continues every 2 weeks for 6 months.
研究设计
- 研究类型
- Interventional
- 主要目的
- Other
入排标准
- 年龄范围
- 65 Years 至 120 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of early-stage breast or prostate cancer within the past 18 months
- •Dietary and physical activity habits and baseline functional status that places patient at risk
- •Potentially able to increase physical activity and to follow a low-fat, plant-based diet
- •Hormone receptor status:
- •Not specified
- •PATIENT CHARACTERISTICS:
- •65 and over
- •Male or female
- •Menopausal status:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •Able to speak and write English
- •No other malignancy within the past 5 years except nonmelanoma skin cancer
- •No other illness or condition that would preclude adherence to a plant-based diet or exercise
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
排除标准
- 未提供
研究者
研究点 (2)
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