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

Solid Tumor, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06469268
• Other study ID #: ePRO-001
• Status: Recruiting
• Phase: N/A
• Start date: May 22, 2024
• Est. completion date: January 3, 2025

Study information

• Verified date: June 2024
• Source: Peking University First Hospital
• Contact: Shikai Wu
• Phone: (86)18910715326
• Email: skywu4329[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 3, 2025
• Est. primary completion date: December 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Histopathology confirmed as malignant tumor;

2. ECOG (Eastern Cooperative Oncology Group) performance status score: 0-1;

3. The expected survival time was =6 months;

4. Intended to receive systemic antitumor therapy (Cisplatin/oxaliplatin regimen);

5. Proficient in using ePRO software after training;

Exclusion Criteria:

1. Patients who were unable to operate the ePRO system without compliance or after repeated training

2. The chemotherapy regimen did not contain cisplatin or oxaliplatin

3. 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

Related Conditions & MeSH terms

• Solid Tumor, Adult

Intervention

Device:
• Epro software
EPRO software:patients with symptoms will fill in report forms via the software, when the data upload to the terminal, the doctor according to the results of the upload ePRO corresponding medical assessment,and give advises.

Locations

Country	Name	City	State
China	Peking University First Hospital Ethics Committee	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Shikai Wu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of health-related quality of life	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.	3 weeks after taking part in this clinical trial
Secondary	Compliance	To evaluate the compliance of ePRO software in patients during clinical trial.During this clinical trial the investigators will offer the same electronic questionnaire to both two groups.At the end of the study, the researchers will analyze the proportion of patients in the two groups who completed the questionnaire.A higher percentage of completions in that group means better compliance	3 weeks after taking part in this clinical trial
Secondary	Incidence of treatment-related severe adverse reactions	The effect of ePRO software on the incidence of treatment-related severe adverse reactions.At the end of the study, the researchers will compare the adverse reactions that occurred during the trial between the two groups of patients according to ctcae4.0.	3 weeks after taking part in this clinical trial