Quality of Life Clinical Trial
Official title:
Prospective Study on Quality of Life in Patients With Intracranial Germ Cell Tumors
The primary purpose of this study is to characterize the quality of life in patients with intracranial germ cell tumors. Those findings can contribute towards a better understanding of the impact of the current treatment strategy on survivors.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | October 30, 2026 |
Est. primary completion date | October 30, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 30 Years |
Eligibility | Inclusion Criteria: - 3 years = age = 21 years - Newly diagnosed primary intracranial germ cell tumors - Written informed consent Exclusion Criteria: - Relapsed disease - Poor compliance |
Country | Name | City | State |
---|---|---|---|
China | Beijing Tiantan Hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Tiantan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change of score of Chinese Wechsler Intelligence Scale for Children | The intelligence of the child was tested by the China-Wechsler Intelligence Scale for Children (C-WISC), which was revised by Gong and Cai at Hunan Medical University. The C-WISC consists of 11 individual tests that include six verbal tests [Information (I), Comprehend (C), Sorting (S), Arithmetic (A), Vocabulary (V), and Digit symbol (D)] and five performance tests [Picture Completing (PC), Picture Arrangement (PA), Block Pattern (BP), Object Assembly (OA), and Coding (CD)]. Based on individual testing, vocabulary scores (V), procedure scores (P), and full scores (F) were obtained. Furthermore, the VIQ, PIQ, and full intelligence quotient (FIQ) were calculated progressively . | Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment. | |
Primary | Change of score of the QoL questionnaire (PedsQL 4.0 : Pediatric Quality of Life Inventory Version 4.0 Generic Core Scales, Chinese edition) | The PedsQL 4.0 Generic Core Scale contains 23 items that measures physical (eight items), emotional (five items), social (five items), and school (five items) functions. The Scale comprises parallel patient self-report and parent proxy-report formats. The items are reverse-scored and trans- formed to a 0-100 scale according to the instructions, and higher scores indicate a better HRQOL. (age =18 years) | Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment. | |
Secondary | Change of score of the QoL questionnaire (Short form-36) | Altogether, 36 questions with standardized response choices were organized into eight scales, including physical functioning (PF), role limitations as a result of physical health problems (RP), body pain (BP), general health perceptions (GH), vitality (VT), social functioning (SF), role limitations as a result of emotional problems (RE), and general mental health (MH). Additionally, reported health transition (HT) was used to evaluate general health changes during the previous year. The raw scores were converted to a 0-100 scale according to the instructions, and higher scores indicated a better HRQOL. Physical component score (PCS) and mental component score (MCS) were also calculated. (Age >15 years) | Evaluation will be evaluated at baseline, yearly through 3 years post-enrolment. |
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