Trial Title:
Validity and Reliability Evaluation of the PRO-CTCAE for Adult-type Diffuse Gliomas Patients in Chinese Population
NCT ID:
NCT05486923
Condition:
Glioma
Patient Reported Outcome Measures
Self Report
Adverse Effects
Conditions: Official terms:
Glioma
Conditions: Keywords:
Glioma
China
Patient Reported Outcome Measures
Self Report
Humans
Adverse effects
Adult
Surveys and Questionnaires
Research Design
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
Adult diffuse glioma patients aged 18 to 85 years who have not received the first
non-surgical treatment after diagnosis/recurrent.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Tian Tan Hospital, Capital Medical University
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoguang Qiu
Facility:
Name:
Tsinghua Changgung Hospital
Address:
City:
Beijing
Country:
China
Status:
Withdrawn
Facility:
Name:
Xuan Wu Hospital, Capital Medical University
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Geng Xu
Facility:
Name:
The First Affiliated Hospital of Chongqing Medical University
Address:
City:
Chongqing
Country:
China
Status:
Withdrawn
Facility:
Name:
The First Affiliated Hospital of Fujian Medical University
Address:
City:
Fuzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Zanyi Wu
Facility:
Name:
Guangdong Sanjiu Brain Hospital
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Linbo Cai
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yonggao Mou
Facility:
Name:
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Contact:
Last name:
Kai Shu
Facility:
Name:
Jiangsu People's Hospital
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongping You
Facility:
Name:
The General Hospital of Ningxia Medical University
Address:
City:
Yinchuan
Country:
China
Status:
Withdrawn
Facility:
Name:
Xijing Hospital
Address:
City:
Xi'an
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhou Fei
Facility:
Name:
Department of Neurologic Surgery, Huashan Hospital, Shanghai Medical College, Fudan University
Address:
City:
Shanghai
Zip:
200040
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinsong Wu, Ph.D. & M.D.
Phone:
+86-21-52887200
Email:
wjsongc@126.com
Facility:
Name:
Changhai Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Juxiang Kong
Facility:
Name:
East Hospital Affiliated To Tongji University
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Chunlong Zhong
Facility:
Name:
Shanghai Proton and Heavy Ion Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Contact:
Last name:
Lin Kong
Facility:
Name:
The First Affiliated Hospital of Kunming Medical University
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiwei Tang
Facility:
Name:
The Second Affiliated Hospital of Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianmin Zhang
Start date:
September 19, 2022
Completion date:
December 1, 2025
Lead sponsor:
Agency:
Huashan Hospital
Agency class:
Other
Source:
Huashan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05486923