NCT02996201已完成不适用
Electronic Patient Reporting of Side Effects to Chemotherapy Among Breast Cancer Patients Using the Patient-Reported Outcomes Version of Common Terminology Criteria for Adverse Events (PRO-CTCAE): A Cluster Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 700
- 主要终点
- Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval)
研究概览
简要总结
The aim of this study is to determine whether the use of breast cancer patients' own electronic reporting of side effects to chemotherapy in a treatment setting has an impact on the handling of side effects and on the number of hospitalizations, febrile neutropenia and dose adjustments. We are using the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for the patients' reporting of side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •More than six scheduled cycles of chemotherapy
- •Not able to read and understand Danish language
结局指标
主要结局
Dose adjustments reported in the medication treatment sheet before each cycle of chemotherapy (5 time points with three weeks interval)
时间窗: up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017
次要结局
- Patients' experience of communication and handling of side effects measured in questionnaire survey and qualitative interviews(up to18 weeks of chemotherapy in the period November 1, 2015 - January 31, 2017)
- Febrile neutropenia reported in the medical record after each of the six cycles of chemotherapy(up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017)
- Patient and staff compliance as registerede by the software used(up to 18 weeks (November 1, 2015 - January 31, 2017))
- Detailed description of side effects in the medical record before start of chemotherapy and after each six cycles of chemotherapy(up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017)
- Number of hospitalizations reported in the medical record after each of the six cycles of chemotherapy(up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017)
- Handling of side effects documented in the medical record(up to 18 weeks of treatment in the period betweeen November 1, 2015 and January 31, 2017)
研究者
Helle Pappot
Chief physician
Rigshospitalet, Denmark
相似试验
招募中
不适用
Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital ConsentComplication of Surgical ProcedureBreast CancerNCT06351865Portsmouth Hospitals NHS Trust50
已完成
不适用
Electronic Reporting of Symptoms After SurgeryPatients Scheduled to Undergo Surgery on the Gynecology ServiceNCT02700256Memorial Sloan Kettering Cancer Center135
已完成
不适用
Effects of application of electronic-patient reported outcome system on QOL and compliance in breast cancer patients receiving adjuvant hormonal therapy: a randomized controlled trial.Breast cancerJPRN-UMIN000044502Showa University130
已完成
不适用
The Care Tracker Study: Using Patient-Reported Data to Address Racial Disparity in Cancer TreatmentCancerBreast CancerColorectal CancerNCT06096623UNC Lineberger Comprehensive Cancer Center100
已完成
不适用
The Ability of Electronic Patient Symptom Reporting to Reduce Symptom Burden During Hospitalization for ChemotherapyStem Cell Transplantation, HematopoieticNCT02574897UNC Lineberger Comprehensive Cancer Center76