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Trial Title:
Development and Application Study of ePRO Software for Managing Cancer Patients Throughout the Treatment Period
NCT ID:
NCT06469268
Condition:
Solid Tumor, Adult
Conditions: Keywords:
Epro
peritherapeutic period
safety
Efficacy
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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
Masking:
Single (Investigator)
Intervention:
Intervention type:
Device
Intervention name:
Epro software
Description:
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.
Arm group label:
Group B
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.
Criteria for 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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University First Hospital Ethics Committee
Address:
City:
Beijing
Zip:
100034
Country:
China
Status:
Recruiting
Contact:
Last name:
Rui Huang
Phone:
010-55119025
Email:
416982188@qq.com
Investigator:
Last name:
Shikai Wu
Email:
Principal Investigator
Start date:
May 22, 2024
Completion date:
January 3, 2025
Lead sponsor:
Agency:
Shikai Wu
Agency class:
Other
Source:
Peking University First Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06469268