Feasibility of Using an Integrated Consent Model to Compare Two Standard of Care Regimens for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induces Febrile Neutropenia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- The percentage of randomized patients in each physician's practice
研究概览
简要总结
The Integrated Consent Model is being increasingly used internationally to improve patient care. In this feasibility study we will explore whether the model is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials, and address the critical issue around the optimal febrile neutropenia prevention by randomizing eligible patients to either G-CSF or ciprofloxacin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed primary breast cancer
- •Planned TC chemotherapy
- •≥19 years of age
- •Able to provide verbal consent
- •Willing to complete a survey
排除标准
- •Contraindication to either Ciprofloxacin or G-CSF
研究组 & 干预措施
G-CSF
Participants will receive a daily injection of G-CSF while on chemotherapy for prevention of febrile neutropenia.
干预措施: G-CSF (Drug)
Ciprofloxacin
Participants will receive Ciprofloxacin 500 mg twice a day by mouth for 10 days of each cycle during chemotherapy for prevention of febrile neutropenia.
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
The percentage of randomized patients in each physician's practice
时间窗: every 4 weeks up to 2 years
The percentage of randomized patients will be measured by collecting reasons for NOT complying with, or "opting-out" of the randomized selection compared to the overall accrual.
次要结局
- rates of febrile neutropenia(Once when the last participant completes chemotherapy up to year 2)