Actively Recruiting

Phase Not Applicable
All Genders
NCT06469268

Development and Application Study of ePRO Software for Managing Cancer Patients Throughout the Treatment Period

Led by Shikai Wu · Updated on 2024-06-21

100

Participants Needed

1

Research Sites

32 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Development and Application Study of ePRO Software for Managing Cancer Patients Throughout the Treatment Period

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histopathology confirmed as malignant tumor
  • ECOG (Eastern Cooperative Oncology Group) performance status score: 0-1
  • Expected survival time of 6 months or more
  • Planned to receive systemic antitumor therapy with cisplatin or oxaliplatin
  • Able to use ePRO software proficiently after training
Not Eligible

You will not qualify if you...

  • Unable to operate the ePRO system despite training or non-compliance
  • Chemotherapy regimen does not include cisplatin or oxaliplatin
  • Other factors assessed by investigators that may cause forced study termination, including non-compliance, serious diseases requiring combined treatment, significant abnormal lab results, family or social issues, or safety concerns affecting data collection

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University First Hospital Ethics Committee

Beijing, Beijing Municipality, China, 100034

Actively Recruiting

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Research Team

S

Shikai Wu

CONTACT

Z

Zhigao Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Development and Application Study of ePRO Software for Managing Cancer Patients Throughout the Treatment Period | DecenTrialz