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

NCT ID: NCT06469268

Condition: Solid Tumor, Adult

Conditions: Keywords:
Epro
peritherapeutic period
safety
Efficacy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Enrolled patients who received cisplatin or oxaliplatin were randomly assigned to one of two groups. Group A 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. Group B 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.

Primary purpose: Supportive Care

Masking: Single (Investigator)

Intervention:

Intervention type: Device
Intervention name: Epro software
Description: 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.
Arm group label: Group B

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Peking University First Hospital Ethics Committee

Address:
City: Beijing
Zip: 100034
Country: China

Status: Recruiting

Contact:
Last name: Rui Huang

Phone: 010-55119025
Email: 416982188@qq.com

Investigator:
Last name: Shikai Wu
Email: Principal Investigator

Start date: May 22, 2024

Completion date: January 3, 2025

Lead sponsor:
Agency: Shikai Wu
Agency class: Other

Source: Peking University First Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06469268

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