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

NCT02608762 | Unknown

• 1 other identifier: 102-5729A3
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumor

Keywords

Pediatric brain tumors; Radiation therapy; Neurobehavioral functions; Proton radiotherapy

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

standard adjuvant local radiation therapy or cranial radiation therapy RADIATION

pediatric/adolescent patients with brain tumors

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Chi-Cheng Yang, Ph.D.

CONTACT

886-988378478; ccyang@mail.cgu.edu.tw

Shinn-Yn Lin, M.D.

CONTACT

+886-33281200; rt3126@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2015
• First Posted: November 20, 2015
• Study Start: September 1, 2013
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

TW (1)