Brain TumorNCT02608762
Neurobehavioral Outcomes and Quality of Life in Pediatric Patients With Brain or Head/Neck Tumors Receiving Proton or Photon Radiotherapy
An observational study of Brain Tumor, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Brain Tumor
- What is being tested?
- standard adjuvant local radiation therapy or cranial radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2013to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric/adolescent patients, who are diagnosed with brain tumors or head/neck cancers, were prospectively recruited.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung Memorial Hospital
Taoyuan, 333
Shinn-Yn Lin, M.D., +886-33281200 ext. 7172, rt3126@gmail.com
About this study
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
- Being tested
- standard adjuvant local radiation therapy or cranial radiation therapy
- Keywords
- Pediatric brain tumors, Radiation therapy, Neurobehavioral functions, Proton radiotherapy
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard adjuvant local radiation therapy or cranial radiation therapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| pediatric/adolescent patients with brain tumors | A prospectively recruited of newly-diagnosed pediatric/adolescent patients with brain tumors or head/neck cancers Receives: Radiation: standard adjuvant local radiation therapy or cranial radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 3 months after the start of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study start1 Sep 2013
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608762
- Sponsor's protocol ID
- 102-5729A3
- Status last verified
- Apr 2023
- First submitted
- 29 Oct 2015
- Last updated
- 1 May 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurobehavioral Outcomes and Quality of Life in Pediatric Patients With Brain or Head/Neck Tumors Receiving Proton or Photon Radiotherapy
- ClinicalTrials.gov ID
- NCT02608762
- Acronym / sponsor ID
- 102-5729A3
- Conditions
- Brain Tumor
- Keywords
- Pediatric brain tumors, Radiation therapy, Neurobehavioral functions, Proton radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Sep 2013 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric/adolescent patients with brain tumors | – | Radiation: standard adjuvant local radiation therapy or cranial radiation therapyA prospectively recruited of newly-diagnosed pediatric/adolescent patients with brain tumors or head/neck cancers |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric/adolescent patients, who are diagnosed with brain tumors or head/neck cancers, were prospectively recruited.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard adjuvant local radiation therapy or cranial radiation therapy | Radiation | pediatric/adolescent patients with brain tumors |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chi-Cheng Yang, Ph.D. (886-988378478, ccyang@mail.cgu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.