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临床试验/NCT06469268
NCT06469268招募中不适用

Development and Application Study of ePRO (Patient Reported Outcome) Software for Managing Cancer Patients Throughout the Treatment Period

Shikai Wu1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年5月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Change of health-related quality of life

研究概览

简要总结

After receiving chemotherapy, targeted therapy, immunotherapy and other drug treatments, tumor patients often experience various adverse reactions such as bone marrow suppression, diarrhea, pneumonia, etc. However, due to the limited capacity of the hospital, if patients who are discharged home cannot timely detect and deal with severe drug adverse reactions, it will cause harm to their bodies and even threaten their life safety. With the rapid development of network communication, many foreign institutions have tried to develop ePRO software based on patient symptom reports. This type of software is used to monitor drug adverse reactions and provide timely feedback to the attending physician for medical intervention. Existing studies have shown that the application of this type of ePRO software significantly reduces the severity of drug adverse reactions on patients and significantly prolongs survival time.

In this study, the investigators plan to collaborate with Shenzhen 123 Digital Medical Group Co., Ltd. to design and develop a tumor ePRO software that allows outpatient treatment period patients who are discharged home to regularly self-assess the severity of drug adverse reactions and automatically feed back the scoring results to the department's monitoring center. Doctors will make timely diagnosis and treatment based on each patient's score results in order to maximize patient safety after treatment at home. The results of this study will provide better follow-up care for tumor patients who are discharged home after anti-tumor treatment by significantly improving the safety of outpatient treatment period patients with tumors and thereby improving patient survival time and quality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Histopathology confirmed as malignant tumor;
  • ECOG (Eastern Cooperative Oncology Group) performance status score: 0-1;
  • The expected survival time was ≥6 months;
  • Intended to receive systemic antitumor therapy (Cisplatin/oxaliplatin regimen);
  • Proficient in using ePRO software after training;

排除标准

  • Patients who were unable to operate the ePRO system without compliance or after repeated training
  • The chemotherapy regimen did not contain cisplatin or oxaliplatin
  • According to the investigator's assessment, the subjects had other factors that might lead to their forced termination of the study, such as non-compliance with the protocol, other serious diseases requiring combined treatment, serious abnormal laboratory test values of clinical significance, family or social factors, and circumstances that may affect the safety of the subjects or the collection of trial data

结局指标

主要结局

Change of health-related quality of life

时间窗: 3 weeks after taking part in this clinical trial

Use EThe EORTC QLG Core Questionnaire(EORTC QLQ-C30 )to evaluate the effect of ePRO software on the quality of life of patients during the chemotherapy period. The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients.The scale contains 30 questions, including treatment response, physical symptoms, mental state, etc. The first 28 options were scored on a scale of 1-4, with a low score indicating a good quality of life or mild symptoms; The last two questions is about Quality of life or health which were scored on a scale of 1-7, with lower scores indicating poorer quality of life or health.

次要结局

  • Compliance(3 weeks after taking part in this clinical trial)
  • Incidence of treatment-related severe adverse reactions(3 weeks after taking part in this clinical trial)

研究者

发起方
Shikai Wu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Shikai Wu

Director of Oncology Department

Peking University First Hospital

研究点 (1)

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