Neurobehavioral Outcomes and Quality of Life in Pediatric Patients With Brain or Head/Neck Tumors Receiving Proton or Photon Radiotherapy

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.

Study Overview

• Status: Recruiting
• Conditions: Brain Tumor
• Intervention / Treatment: Radiation: standard adjuvant local radiation therapy or cranial radiation therapy

• Study Type: Observational
• Enrollment (Anticipated): 72

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric/adolescent patients, who are diagnosed with brain tumors or head/neck cancers, were prospectively recruited.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change in Intellectual functioning from baseline to 3 months after the start of radiotherapy	Intellectual functioning mainly includes subtests of Wechsler Intelligence scale for Children	1 week before the start of radiotherapy and 3 months after the start of radiotherapy
Neurobehavioral functions and psychosocial adjustments	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).	3 months after the start of radiotherapy

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: October 29, 2015
• First Submitted That Met QC Criteria: November 17, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Radiation therapy; Proton radiotherapy; Pediatric brain tumors; Neurobehavioral functions
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 102-5729A3