跳至主要内容
临床试验/NCT03168048
NCT03168048Unknown不适用

Oncologic Therapy Support Via Means of a Dedicated Mobile App - a Prospective Feasibility Evaluation

Heidelberg University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Feasibility judged by number of questions answered by each patient on each treatment day

研究概览

简要总结

The present single-center prospective exploratory study, conducted at Heidelberg University Hospital, assesses the feasibility of introducing a concept for additional patient care based on a mobile application for patients undergoing radiotherapy. Patients presenting themselves for the irradiation of thoracic or pelvic tumors will be surveyed regarding general performance, treatment-related Quality of Life (QoL) and symptoms and their need to personally consult a physician on a treatment-daily basis by means of a mobile application. The primary endpoint of feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day. Furthermore, treatment-related patient satisfaction and diagnosis-related QoL is assessed by PSQ-18 and EORTC questionnaires at the end of radiotherapy and at the first follow-up.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Indication for radiotherapy with potentially curative intent of a primarily thoracic or pelvic target
  • •Karnofsky performance score (KPS) ≥ 70%,
  • •Ability to initiate the therapy as an outpatient
  • •≥ 18 years of age

排除标准

  • •Inability to give informed consent

研究组 & 干预措施

Mobile application

Experimental

Patients undergoing radiotherapy will receive additional therapy support by an application installed on a mobile device

干预措施: mobile application (Other)

结局指标

主要结局

Feasibility judged by number of questions answered by each patient on each treatment day

时间窗: 12-14 weeks

Feasibility will be reached when 80% of the patients have successfully answered 80% of their respective questions scheduled for each treatment day

次要结局

  • Treatment-related patient satisfaction(12-14 weeks)
  • Diagnosis-related Quality of Life(12-14 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nils Nicolay, PD Dr. Dr.

PD Dr. Dr. Nils Nicolay

Heidelberg University

研究点 (1)

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