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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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;

Locations
Other Locations
China
Peking University First Hospital Ethics Committee
RECRUITING
Beijing
Contact Information
Primary
Shikai Wu
skywu4329@sina.com
(86)18910715326
Backup
Zhigao Wang
422487997@qq.com
8615231129253
Time Frame
Start Date: 2024-05-22
Estimated Completion Date: 2025-01-03
Participants
Target number of participants: 100
Treatments
No_intervention: Group A
This was the routine observation group, 50 patients were enrolled in the group. After receiving antineoplastic drug treatment, they were discharged home, and the treatment-related adverse reactions were observed and intervention according to the routine process.
Experimental: Group B
This was the ePRO study group: A total of 50 patients were enrolled in this group. After receiving anti-tumor drug treatment, the ePRO system was installed through the mobile phone. After training, the patients could skillfully use the ePRO system.
Related Therapeutic Areas
Sponsors
Leads: Shikai Wu

This content was sourced from clinicaltrials.gov