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

NCT ID: NCT06469268

Last Updated: 2024-06-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-22
• Study Completion Date: 2025-01-03

Brief 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.

Conditions

Solid Tumor, Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Epro software

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shikai Wu

OTHER

Sponsor Role: lead

Responsible Party

Shikai Wu

Director of Oncology Department

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Shikai Wu

Role: PRINCIPAL_INVESTIGATOR

Peking Univerisity First Hospital

Locations

Peking University First Hospital Ethics Committee

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Shikai Wu

Role: CONTACT

skywu4329@sina.com

(86)18910715326

Zhigao Wang

Role: CONTACT

422487997@qq.com

8615231129253

Facility Contacts

Rui Huang

Role: primary

416982188@qq.com

010-55119025

Other Identifiers

ePRO-001

Identifier Type: -

Identifier Source: org_study_id