Trial record 2 of 12 for:    neuropsychological outcomes and children and cancer | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT02608762
First received: October 29, 2015
Last updated: November 17, 2015
Last verified: September 2014
  Purpose

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 Intervention Phase
Brain Tumor
Radiation: standard adjuvant local radiation therapy or cranial radiation therapy
Phase 2

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:
  • 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).



Estimated Enrollment: 72
Study Start Date: September 2014
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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.
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02608762

Contacts
Contact: Chi-Cheng Yang, Ph.D. 886-988378478 ccyang@mail.cgu.edu.tw
Contact: Shinn-Yn Lin, M.D. +886-33281200 ext 7172 rt3126@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan, 333
Contact: Shinn-Yn Lin, M.D.    +886-33281200 ext 7172    rt3126@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
  More Information

Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT02608762     History of Changes
Other Study ID Numbers: 102-5729A3 
Study First Received: October 29, 2015
Last Updated: November 17, 2015

Keywords provided by Chang Gung Memorial Hospital:
Pediatric brain tumors
Radiation therapy
Neurobehavioral functions
Proton radiotherapy

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on January 24, 2017