Neurobehavioral Outcomes and Quality of Life in Pediatric Patients With Brain or Head/Neck Tumors Receiving Proton or Photon Radiotherapy
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|ClinicalTrials.gov Identifier: NCT02608762|
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : January 30, 2018
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.
|Condition or disease||Intervention/treatment|
|Brain Tumor||Radiation: standard adjuvant local radiation therapy or cranial radiation therapy|
|Study Type :||Observational|
|Estimated Enrollment :||72 participants|
|Study Start Date :||September 2014|
|Estimated Primary Completion Date :||December 2018|
pediatric/adolescent patients with brain tumors
A prospectively recruited of newly-diagnosed pediatric/adolescent patients with brain tumors or head/neck cancers
Radiation: standard adjuvant local radiation therapy or cranial radiation therapy
- The change in Intellectual functioning from baseline to 3 months after the start of radiotherapy [ Time Frame: 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
- Neurobehavioral functions and psychosocial adjustments [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02608762
|Contact: Chi-Cheng Yang, Ph.D.||firstname.lastname@example.org|
|Contact: Shinn-Yn Lin, M.D.||+886-33281200 ext email@example.com|
|Chang Gung Memorial Hospital||Recruiting|
|Taoyuan, Taiwan, 333|
|Contact: Shinn-Yn Lin, M.D. +886-33281200 ext 7172 firstname.lastname@example.org|