Pilot Study for Tablet-based Questionnaire of Patient-reported Outcomes From Patients Undergoing Chemotherapy (TabPRO I)
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
- 3
- 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
研究组 & 干预措施
Tablet-based reported outcome
With the start of chemotherapy until the end of the last cycle of chemotherapy the study participants have to document all signs of discomfort or changes to their overall coenesthesia in the tablet-based questionnaire.
干预措施: Tablet-based questionnaire (Device)
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