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

NCT06469268 | Recruiting

• 1 other identifier: ePRO-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Epro; peritherapeutic period; safety; Efficacy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Compliance

  3 weeks after taking part in this clinical trial

• Incidence of treatment-related severe adverse reactions

  3 weeks after taking part in this clinical trial

Study Arms (2)

Group A

NO INTERVENTION

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 B

EXPERIMENTAL

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.

Device: Epro software

Interventions

Epro software 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.

Group B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• Patients who were unable to operate the ePRO system without compliance or after repeated training
• The chemotherapy regimen did not contain cisplatin or oxaliplatin
• 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

Sponsors & Collaborators

• Shikai Wu: lead

Study Sites (1)

Peking University First Hospital Ethics Committee

Beijing, Beijing Municipality, 100034, China

RECRUITING

Study Officials

• Shikai Wu

  Peking Univerisity First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shikai Wu

CONTACT

(86)18910715326; skywu4329@sina.com

Zhigao Wang

CONTACT

8615231129253; 422487997@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Oncology Department

Model Details: 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.

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 21, 2024
• Study Start: May 22, 2024
• Primary Completion: December 12, 2024
• Study Completion: January 3, 2025
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

CN (1)