Clinical trial NCT06469268: Development and Application Study of ePRO Software for Managing Cancer Patients Throughout the Treatment Period
Official title: Development and Application Study of ePRO (Patient Reported Outcome) Software for Managing Cancer Patients Throughout the Treatment Period
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Tumor, Adult
Keywords: Epro
peritherapeutic period
safety
Efficacy
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-06-21
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.


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

Primary outcomes:
measure: Change of health-related quality of life
timeFrame: 3 weeks after taking part in this clinical trial
Secondary outcomes:
measure: Compliance
timeFrame: 3 weeks after taking part in this clinical trial
measure: Incidence of treatment-related severe adverse reactions
timeFrame: 3 weeks after taking part in this clinical trial
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital Ethics Committee
state: Beijing
Study officials:
affiliation: Peking Univerisity First Hospital
name: Shikai Wu
role: PRINCIPAL_INVESTIGATOR
References: