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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor, Adult
• Intervention / Treatment: Device: Epro software

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shikai Wu; Phone Number: (86)18910715326; Email: skywu4329@sina.com
• Study Contact Backup: Name: Zhigao Wang; Phone Number: 8615231129253; Email: 422487997@qq.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital Ethics Committee
      • Principal Investigator: Shikai Wu
      • Contact: Rui Huang; Phone Number: 010-55119025; Email: 416982188@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Shikai Wu
• Investigators: Principal Investigator: Shikai Wu, Peking Univerisity First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 22, 2024
• Primary Completion (Estimated): December 12, 2024
• Study Completion (Estimated): January 3, 2025

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: safety; Efficacy; Epro; peritherapeutic period
• Other Study ID Numbers: ePRO-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No