Real-world Clinical Benefit Evaluation in Breast Cancer Patients With Pharmaceutical Interventions for Cancer-related Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 261
- 试验地点
- 9
- 主要终点
- Fatigue Improvement
研究概览
简要总结
This retrospective study is to collect and analyze the data from medical records within the period that breast cancer patient is receiving NHI-covered CRF treatment. This study will evaluate the clinical use, fatigue improvement, and treatment satisfaction of breast cancer patients with CRF treatment.
详细描述
This is a single arm, multicenter, and retrospective study. About 200 breast cancer patients' data from medical records are expected to collect and analyze in this retrospective study. The data collection from medical records of breast cancer patients who approved to use NHI to pay for CRF treatment drug will include the demographic information, disease characteristics and cancer treatment information, fatigue score by visual analog fatigue scale, fatigue clinical global impression, CRF pharmacological treatment record, hematological lab data, ECOG, cancer drug compliance record, overall clinical evaluation after CRF treatment by physicians and patient's expectation to continue CRF treatment etc. Data of three return visits (i.e. at the time of before CRF treatment, after 4 times of CRF treatment and CRF treatment completed) per patient will be collected from medical records to analysis within the period that patient is receiving NHI-covered CRF treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •breast cancer patients who approved to use NHI to pay for cancer-related fatigue treatment drug
排除标准
- 未提供
结局指标
主要结局
Fatigue Improvement
时间窗: through study completion, an average of 4 months
次要结局
- The Level of Fatigue Clinical Global Impression-Improvement(through study completion, an average of 4 months)
- ECOG Change(through study completion, an average of 4 months)
- Weight Change(through study completion, an average of 4 months)
- Patient Expectation Rating of Continuous Cancer-Related Fatigue Treatment(1 time, average of 4 months after baseline (at the end of study))
- The Incidence of Cancer Treatent Delay(through study completion, an average of 4 months)
- Physician Satisfaction Degree of Overall Clinical Evaluation(1 time, average of 4 months after baseline (at the end of study))
- Hematological Lab Data Change(through study completion, an average of 4 months)
- The Incidence of Cancer Treatent Dose Modification(through study completion, an average of 4 months)
研究者
Ming-Shen Dai
Chief of Department of Oncology
National Defense Medical Center, Taiwan