Validity and Reliability Evaluation of the PRO-CTCAE for Adult-type Diffuse Gliomas Patients in Chinese Population

Launched by HUASHAN HOSPITAL · Aug 1, 2022

Keywords

ClinConnect Summary

This clinical trial, called VERONICA, is looking to improve how we understand the experiences of patients with adult-type diffuse gliomas, a type of brain tumor. The researchers want to create a questionnaire (called PRO-CTCAE™) that helps capture patients' reports of symptoms and side effects they experience during treatment. This study is particularly focused on Chinese patients, and it will first gather expert opinions and feedback from patients to ensure the questionnaire is relevant and effective. After that, the trial will involve multiple centers to test how well this questionnaire works in measuring the experiences of glioma patients going through treatment.

To be eligible for the trial, participants need to be between 18 and 85 years old and have a confirmed diagnosis of adult diffuse glioma. Newly diagnosed patients should not have started their first treatment yet, while those with recurrent disease should not have received treatment after their recurrence. It’s important that participants are able to use mobile devices or computers and can understand Chinese at a basic level. Those who join can expect to fill out the questionnaire and share their experiences, helping to improve care and understanding for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Pathologically diagnosed adult diffuse glioma patients( including astrocytoma, IDH-mutant; oligodendroglioma, IDH-mutant and1p/19q-codeleted; glioblastoma, IDH-wildtype; other adult diffuse glioma NEC/NOS).
• • 2. For newly diagnosed patients, the patient has not received the first non-surgical treatment.
• • 3. For recurrent patients, the patient has not received the first non-surgical treatment after the recurrence.
• • 4. 18 to 85 years old.
• • 5. No significant cognitive impairment based on researchers' judgment.
• • 6. Patients can use mobile phones or computers on their own or with the help of others, read and understand Chinese, at least with primary school culture.
• • 7. Patients are undergoing anti-tumor treatment and continue to receive treatment within the next 28 days.
• • 8. Patients sign written informed consent.
• Exclusion Criteria:
• • 1. Patients who are not considered suitable for this study.
• • 2. Since the diagnosis, the patient has undergone non-surgical treatment.
• • 3. Patients fail to complete the questionnaire within 42 days of signing informed consent.