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

Fudan University

Status: Completed

Conditions: Self Report; Glioma; Adverse Effects; Patient Reported Outcome Measures

Study type: Observational

Funder types: Other

Identifiers

NCT05486923

KY2022-681

Details and patient eligibility

About

Given the increasing importance of patient's perspective in adverse events reporting, Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) has been proposed as new PRO measures in oncology; however, its implementation has not yet been evaluated in glioma patients, and standardized selection process of priority symptom terms has not been applied.

The study focuses on Chinese adult-type diffuse glioma patients. First, based on information queries, expert consultation research, online Delphi survey, and survey data analysis, the investigators will determine the questionnaire terms for PRO-CTCAE™ for adult-type diffuse gliomas patients. In the next stage, a prospective, multi-center, real-world study to assess the validity, reliability, and responsiveness of the customized PRO-CTCAE™ for adult-type diffuse gliomas patients in Chinese population will be launched (VERONICA).

Full description

First, based on information queries, expert consultation research, online Delphi survey, and survey data analysis, the investigators will determine the questionnaire terms for PRO-CTCAE™ for adult-type diffuse gliomas patients.

A total of 16 experts (13 neurosurgeons, 2 radiotherapists, 1 psychiatrist) from 14 medical centers in China were invited to participate in a consensus-seeking 2-round online Delphi survey. Participants rated the level of their agreement with each symptom term likely to occur during adult diffuse gliomas treatment on a 5-point Likert scale. Terms not reaching consensus over the first round were modified in the second rounds. Consensus was defined as content validity index (CVI) >0.78，coefficient of variation (CV)< 0.35 and average Likert score >3.00.

Second, a prospective, multi-center, real-world study would be performed to assess the validity, reliability, and responsiveness of the customized PRO-CTCAE™ for adult diffuse glioma patients in Chinese population.

This study is an observational, prospective, open-label clinical study. It is estimated that 450 adult diffuse glioma patients will be recruited from 17 research centers, and participants will be included in the cohort in chronological order until the target number of cases is reached. The study is expected to be completed within 2 years. In this study, KPS will be used as the anchor point to compare two groups of patients(KPS≤70 and KPS>70, patients with KPS≤70 is not less than 15%).

The investigators do not intervene in the current treatment plan for patients, only observe the treatment plan, and conduct regular questionnaires on the patients: since the patients are enrolled (within 42 days after surgery), six basic follow-ups and long-term follow-ups will be carried out. The whole follow-ups will last for two years.

The follow-up contents include:

Filled out by doctors: demographic information, diagnosis information, anti-tumor treatment (in the past 2 weeks), special treatment (in the past 2 weeks, including but not limited to dehydration drugs and psychotropic drugs, etc.), CTCAE v5.0 (only including the items corresponding to PRO-CTCAE™), KPS.

Filled out by patients: customized PRO-CTCAETM, QLQ-C30, GIC.

Data will be collected using EDC system to ensure patient privacy and data integrity.

The statistical analysis methods:

For the customized PRO-CTCAE™, quantitatively assign each item and its answers (F, S, A, I, P), and then use statistical methods to assess the validity, reliability, and responsiveness of the customized PRO-CTCAE™ for adult diffuse glioma patients in Chinese population.

Enrollment: 450 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

450 participants in 2 patient groups

KPS less than 70

Description:

The patients in this group have Karnofsky performance Status less than 70，and the proportion of them is not less than 15%. Patients need regular follow-up surveys within 2 years after the date of surgery.

KPS more than 70

Description:

The patients in this group have Karnofsky performance Status more than 70. Patients need regular follow-up surveys within 2 years after the date of surgery.