Neurobehavioral Outcomes and Quality of Life in Pediatric Patients With Brain or Head/Neck Tumors Receiving Proton or Photon Radiotherapy
- Conditions
- Brain Tumor
- Interventions
- Radiation: standard adjuvant local radiation therapy or cranial radiation therapy
- Registration Number
- NCT02608762
- Lead Sponsor
- Chang Gung Memorial Hospital
- Brief Summary
Background: Neurobehavioral functions and quality of life (QoL) are the important outcome measurements after radiotherapy in patients with brain tumors and even head/neck cancers. However, few studies have focused on neurobehavioral functions and QoL after anti-cancer treatment particularly brain radiotherapy for pediatric/adolescent patients with brain tumors. This study thus aims to prospectively evaluate those functions in pediatric or adolescent patients with brain or head/neck tumors in order to provide useful information about their clinical outcomes.
Methods: A total of 72 pediatric/adolescent patients, who are diagnosed with brain tumors or head/neck cancers, were prospectively recruited. Neurobehavioral functions will be evaluated using a neuropsychological battery, which includes general cognitive functions, intelligence, memory, executive functions, information processing and emotional/behavioral expressions. The QoL will be evaluated by the health-related QoL questionnaire. All participants will be examined at six phases, which include pre-treatment, 1-month post-treatment, 4-month post-treatment, 1-year post-treatment, 2-year post-treatment and 3-year post-treatment.
Expected results: Patients'neurobehavioral functions and QoL will show significant improvement after treatment, and the improvement will not be diminished across each post-treatment phase.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 72
- Pediatric patients diagnosed with brain tumors or head/neck cancers who are no older than 18 years old
- Patients should be considered indicated for receiving the subsequent course of local radiotherapy
- Patients who received radiotherapy once before
- Patients have visual and/or hearing impairments which obviously impede the administration of neurocognitive assessment
- Patients cannot underwent brain MRI examination because of clinical contraindications, such as renal insufficiency (GFR <30)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description pediatric/adolescent patients with brain tumors standard adjuvant local radiation therapy or cranial radiation therapy A prospectively recruited of newly-diagnosed pediatric/adolescent patients with brain tumors or head/neck cancers
- Primary Outcome Measures
Name Time Method Neurobehavioral functions and psychosocial adjustments 3 months after the start of radiotherapy In this study, evaluations of neurocognitive functions include memory scores of verbal memory (NEPSY-II),memory scores of non-verbal memory (NEPSY-II) raw scores of executive functions (NEPSY-II), raw scores of processing speed (NEPSY-II), raw scores of attention (Continuous Performance Test, CPT).
Evaluations of psychosocial adjustments mainly include severity scores of behavioral problems (Achenbach System of Empirically Based Assessment),scores of behavioral problems(Vineland Adaptive Behavior Scale), scores of parental stress (Parenting Stress Index, PSI) and scores on the scale for quality of life (Child Health Questionnaire, CHQ).The change in Intellectual functioning from baseline to 3 months after the start of radiotherapy 1 week before the start of radiotherapy and 3 months after the start of radiotherapy Intellectual functioning mainly includes subtests of Wechsler Intelligence scale for Children
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan