Development and Application Study of ePRO Software for Managing Cancer Patients Throughout the Treatment Period
NCT Number: NCT06469268
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Solid Tumor, Adult
Interventions: DEVICE: Epro software
Sponsor: Shikai Wu
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-05-22
Completion Date: 2025-01-03
Locations: Peking University First Hospital Ethics Committee, Beijing, Beijing, 100034, China

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.

Primary Outcome Measures: 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: 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