NCT01991691已完成不适用
Pilot Study for Tablet-based Questionnaire of Patient-reported Outcomes From Patients Undergoing Chemotherapy (TabPRO I)
University Hospital, Bonn5 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2013年9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
- 入组人数
- 57
- 试验地点
- 5
- 主要终点
- Feasibility of Tablet-based questionnaire of PRO
研究概览
简要总结
This study is a single arm feasibility study. Patients that have been diagnosed with carcinoma and are undergoing chemotherapy have to document chemotherapy associated side effects on a regular basis by means of a tablet-based online questionnaire. Goal of the study is to find out if patients that are undergoing chemotherapy are willing to document chemotherapy associated side effects by means of a tablet-based online questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients have to be ≥ 18 years of age
- •written consent form and agreement to participate in the study
- •patients that are able to follow the study instructions and that most likely will keep the required study appointments
- •patients that have a histological confirmed carcinoma and are scheduled to undergo adjuvant or neoadjuvant chemotherapy of 6 to 8 cycles
- •questions about chemotherapy associated side effects are composed in german. Therefore the study participants must have sufficient knowledge of the german language
- •ECOG maximal level 2
排除标准
- •patients that are younger than 18 years
- •patients that don't agree to take part of the study
- •patients that are not able to understand the scope, the meaning and the consequences of that clinical study
- •patients that have a known or constant addiction to drugs or alcohol
- •patients that suffer from blindness or dyslexia
结局指标
主要结局
Feasibility of Tablet-based questionnaire of PRO
时间窗: 6 months
Feasibility of Tablet-based questionnaire of PRO (\>60% of patients answer \>60% of questionnaires in the time frame of study duration)
次要结局
- Answered questionnaires per patient(6 months)
研究者
Michael Mallmann, MD
Coordinating Investigator
University Hospital, Bonn
研究点 (5)
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