NCT00156039已完成4 期
A Randomized Trial of Follow-up Strategies in Breast Cancer
Ontario Clinical Oncology Group (OCOG)5 个研究点 分布在 1 个国家目标入组 968 人开始时间: 1997年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 968
- 试验地点
- 5
- 主要终点
- Rate of Karnofsky performance status < 70
研究概览
简要总结
The purpose of this study is to determine whether family physician 'routine follow-up care' of women with breast cancer in remission is an acceptable alternative to the existing system of specialist follow-up. Primary outcome measure are event rates of oncological catastrophes and quality of life.
详细描述
see above
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with breast cancer on well follow-up at regional cancer centres in Ontario and Manitoba
- •Diagnosed at least 12 months previously (range 9-15 months)
- •Without evidence of active disease (i.e., stages IIIB and IV excluded)
- •Free from any primary treatment complications
排除标准
- •Primary treatment at least 3 months previously, except for continued use of tamoxifen
- •Still experiencing complications of primary treatment (patients will become eligible once complications resolve provided they are within the 6 month window)
- •Unable to identify an acceptable family physician to provide follow-up
- •Language or literacy skills inconsistent with completing questionnaires
- •Unable to comply with study protocol including completion of questionnaires
- •Previously enrolled in a study which requires continued follow-up in specialist or peripheral clinics
- •Actively followed at a cancer centre for another primary cancer
结局指标
主要结局
Rate of Karnofsky performance status < 70
时间窗: Up to 5 yrs after randomization
Rate of clinically catastrophic events
时间窗: Up to 5 yrs after randomization
Psychosocial well being of patients in remission
时间窗: Up to 5 yrs after randomization
次要结局
- Economic evaluation(Up to 5 yrs after randomization)
- Survival(Up to 5 yrs after randomization)
- Health Related Quality of Life after recurrence(Up to 5 yrs after randomization)
研究者
研究点 (5)
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