Clinical trial NCT05486923: Validity and Reliability Evaluation of the PRO-CTCAE for Adult-type Diffuse Gliomas Patients in Chinese Population
Official title: Validity and Reliability Evaluation of the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for Adult-type Diffuse Gliomas Patients in Chinese Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioma
Patient Reported Outcome Measures
Self Report
Adverse Effects
Keywords: Glioma
China
Patient Reported Outcome Measures
Self Report
Humans
Adverse effects
Adult
Surveys and Questionnaires
Research Design
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2022-08-04
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult diffuse glioma patients aged 18 to 85 years who have not received the first non-surgical treatment after diagnosis/recurrent.

Brief summary: 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).

Detailed 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.

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.

Primary outcomes:
measure: the validity, reliability, and responsiveness of the customized PRO-CTCAE™ for adult-type diffuse gliomas patients in Chinese population
timeFrame: December 1, 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tian Tan Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Tsinghua Changgung Hospital
state: Beijing
city: Beijing
country: China
facility: Xuan Wu Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Sanjiu Brain Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
state: Hubei
city: Nanjing
country: China
facility: Jiangsu People's Hospital
state: Jiangsu
city: Yinchuan
country: China
facility: The General Hospital of Ningxia Medical University
state: Ningxia
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
city: Shanghai
country: China
facility: Department of Neurologic Surgery, Huashan Hospital, Shanghai Medical College, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
city: Shanghai
country: China
facility: East Hospital Affiliated To Tongji University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Proton and Heavy Ion Hospital
state: Shanghai
city: Kunming
country: China
facility: The First Affiliated Hospital of Kunming Medical University
state: Yunnan
city: Hangzhou
country: China
facility: The Second Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Huashan Hospital
name: Jinsong Wu, Ph.D. & M.D.
role: STUDY_CHAIR
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