Using ePRO software to manage cancer patients during treatment
Development and Application Study of ePRO (Patient Reported Outcome) Software for Managing Cancer Patients Throughout the Treatment Period
This study tests a new software that helps cancer patients report their symptoms during treatment to see if it can improve their safety and care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Sex | All |
| Sponsor | Peking University First Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06469268 on ClinicalTrials.gov |
What this trial studies
This study focuses on the development and application of electronic Patient Reported Outcomes (ePRO) software to monitor and manage adverse reactions in cancer patients undergoing systemic antitumor therapy. By enabling patients to report symptoms and side effects in real-time, the software aims to facilitate timely medical interventions from healthcare providers. The study targets patients with solid tumors who are receiving chemotherapy regimens that include cisplatin or oxaliplatin, with the goal of improving patient safety and outcomes during the treatment period.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with histopathologically confirmed malignant tumors who are expected to survive for at least six months and are proficient in using the ePRO software.
Not a fit: Patients who are unable to comply with the ePRO system or those receiving chemotherapy regimens that do not include cisplatin or oxaliplatin may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the severity of drug adverse reactions and improve survival rates for cancer patients.
How similar studies have performed: Previous studies have shown that ePRO software can effectively reduce the severity of drug adverse reactions and improve patient survival, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Peking University First Hospital Ethics Committee — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Principal investigator: Shikai Wu — Peking Univerisity First Hospital
- Study coordinator: Shikai Wu
- Email: skywu4329@sina.com
- Phone: (86)18910715326
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.