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This study will assess cognitive function in patients with a primary brain tumour treated with radiation therapy (RT) to generate radio-sensitivity and volume effect parameters for the development of cognitive dysfunction. All types of brain tumours apart from glioblastoma will be included.
RT is fundamental in the treatment of primary brain tumours. RT contributes to improved local control and prolonged progression-free survival in patients with a broad range of tumour types. Irradiation to the normal brain may lead to cognitive impairments. Clarifying the nature and severity of impairment in adult RT-treated brain tumour patients, including region-specific effects, are important for optimal utilization of novel conformal RT technologies such as proton therapy.
The study is a prospective nationwide study including approximately 300 brain tumour patients from the Danish Center of Particle Therapy and the four Neuro Oncology Centers in Denmark.
The patients will be assessed with a comprehensive battery of standardized cognitive tests and complete a questionnaire (PRO's). They will do this prior to RT treatment and 1, 3, 5 and 10 years afterwards. The PRO's includes measures on quality of life, fatigue, sleep, depression, anxiety, and socio demographics. The standardized tests are: Trail making Test (TMT); Hopkins Verbal Learning Test (HVLT); Controlled Oral Word Association Test (COWAT) - Animals and S; Coding and Digit Span from WAIS-IV. The correlation between cognitive scores and RT dose-volume parameters to specific areas in the brain will be tested.
This study will elucidate the dose-response relationship in radiation-induced damage to substructures of the brain such as hippocampus, thalamus, temporal and frontal lobes that will allow the clinician to prioritize these structures in planning of proton radiotherapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive tests and Patient Reported Outcomes | Other | Each patient will undergo cognitive tests and questionnaires |
| Measure | Description | Time Frame |
|---|---|---|
| Impairment of verbal learning and memory as assessed by the HVLT-r test | Examined by the Hopkins Verbal Learning Test revised. It will be correlated to the mean radiation dose to the hippocampus. Outcome is number of correct words (0-24) | 10 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Processing speed I | Examined by the Trail making Test part A (TMT_A). Outcome for TMT_A is time in seconds (0-120 seconds). | 10 years |
| Processing speed II | Examined by the Coding from Wechsler Adult Intelligence Scale (WAIS-IV). Outcome for Coding is number of correct (within 2 minutes) (0-100) |
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Inclusion Criteria:
Exclusion Criteria:
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The patients will be diagnosed with a primary brain tumour and referred to radiation therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Morten Høyer, MD | Contact | +45 2328 2823 | morthoey@rm.dk | |
| Lene Haldbo-Classen, MD | Contact | +4523342761 | lenhaldb@rm.dk |
| Name | Affiliation | Role |
|---|---|---|
| Lene Haldbo-Classen, M.D | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Oncology, Rigshospitalet | Recruiting | Copenhagen | Capital Region | 2100 | Denmark |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D060825 | Cognitive Dysfunction |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
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| 10 years |
| Attention and working memory | Examined by Wechsler Adult Intelligence Scale (WAIS_IV_digit_span). Outcome on WAIS digit span is number of correct (0-36) | 10 years |
| Verbal learning and memory | Examine by the Hopkins Verbal Learning Test revised (HVLT-r) - total and delayed. Outcome is number of correct words (0-24) | 10 years |
| Verbal fluency | Examined by the Controlled Oral Word Association Test (COWAT) - Animals and letter_S. Outcome is number of words produced in 1 minute (0-100) | 10 years |
| Executive function I | Examined by Trail making Test part B (TMT_B). Outcome for TMT_B is time in seconds (0-300). | 10 years |
| Executive function II | Examined by the STROOP colour and word test (STROOP). Outcome for STROOP is number of corrects (0-120) | 10 years |
| Global Health - Quality of life | Assessed by questionnaire; European organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30) in order to examine the level of quality of life in brain tumour patients who has received radiation therapy. The total score is a number (0-100) | 10 years |
| Side effects to radiation therapy | Assessed by EORTC Brain Neoplasm Questionnaire, BN20 (an addition to QLQ-C30 mentioned above) in order to measure side effects to radiation therapy for a brain tumour. the score is a number (0-100) | 10 years |
| Quality of Sleep | Assessed by questionnaire: Pittsburgh Sleep Quality INDEX, (PSQI) in order to explore the level of quality of sleep in brain tumour patients who has received radiation therapy. Outcome is a number (0-33) | 10 years |
| Fatigue | Assessed by questionnaire: Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue scale (version 4) in order to explore the level of fatigue in brain tumour patients who has received radiation therapy. Outcome is a number (0-52) | 10 years |
| Depression/Anxiety | Assessed by questionnaire: Hospital anxiety and depression Scale (HADS) in order to explore level of depression and anxiety in patients treated with radiation therapy for their brain tumour. Outcome is a number (0-56) | 10 years |
| Patient's Assessment of Own Functioning | Assessed by questionnaire; Patient's Assessment of Own Functioning Inventory (PAOFI), in order to assess patients own perception of cognitive function. Outcome is a number (35-210) | 10 years |
| Danish Center for Particel Therapy | Recruiting | Aarhus | Region Midt | 8200 | Denmark |
|
| Department of Oncology, Aarhus University Hospital | Recruiting | Aarhus | Region Midt | 8200 | Denmark |
|
| Department of Oncology, Aalborg University Hospital | Recruiting | Aalborg | Region Nord | 9000 | Denmark |
|
| Department of Oncology, Odense University Hospital | Recruiting | Odense | Region Syd | 5000 | Denmark |
|
| D016543 |
| Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |