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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

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