Quality of Life in Patients Who Have Undergone Previous Treatment for Primitive Neuroectodermal Tumors
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00278239|
Recruitment Status : Unknown
Verified April 2006 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 18, 2006
Last Update Posted : September 20, 2013
RATIONALE: Questionnaires that measure quality of life may improve the ability to plan treatment for patients with primitive neuroectodermal tumors.
PURPOSE: This phase III trial is studying quality of life in patients who have undergone previous treatment for primitive neuroectodermal tumors.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Cognitive/Functional Effects Long-term Effects Secondary to Cancer Therapy in Children Psychosocial Effects of Cancer and Its Treatment||Procedure: cognitive assessment Procedure: psychosocial assessment and care Procedure: quality-of-life assessment||Phase 3|
- Determine the quality of survival of patients in the UK and other European countries enrolled in previous International Society of Pediatric Oncology (SIOP) 2 or 3 phase III trials for treatment of pediatric primitive neuroectodermal tumors (PNET).
- Compare the quality of survival between children allocated to different treatments in these trials.
- Determine the framework that will allow similar information to be collected across all participating countries in the PNET 4 trial that opened in autumn 2002.
OUTLINE: This is a cross-sectional, multicenter study.
Pediatric oncologists, teachers, patients ≥ 12 years old, and parents of children age 3-11 years old complete six questionnaires to assess the patients' motor and sensory function, cognition, behavior, emotion, educational provision and achievement, social integration, and the subjective experience of the patients and their families.
PROJECTED ACCRUAL: A total of 229 patients will be accrued for this study.
|Study Type :||Observational|
|Official Title:||Study of Outcome of Children Previously Enrolled in European Trials of Treatment for Primitive Neuroectodermal Tumour (PNET)|
|Study Start Date :||June 2002|
- Quality of life (QOL) as measured by QOL questionnaire
- Quality of survival compared among children undergoing different treatments by Health Utilities Index
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00278239
|Our Lady's Hospital for Sick Children|
|Dublin, Ireland, 12|
|Birmingham Children's Hospital|
|Birmingham, England, United Kingdom, B4 6NH|
|Institute of Child Health at University of Bristol|
|Bristol, England, United Kingdom, BS2 8AE|
|Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust|
|Cambridge, England, United Kingdom, CB2 2QQ|
|Leeds Cancer Centre at St. James's University Hospital|
|Leeds, England, United Kingdom, LS9 7TF|
|Leicester Royal Infirmary|
|Leicester, England, United Kingdom, LE1 5WW|
|Royal Liverpool Children's Hospital, Alder Hey|
|Liverpool, England, United Kingdom, L12 2AP|
|Royal London Hospital|
|London, England, United Kingdom, E1 1BB|
|Great Ormond Street Hospital for Children NHS Trust|
|London, England, United Kingdom, WC1N 3JH|
|Central Manchester and Manchester Children's University Hospitals NHS Trust|
|Manchester, England, United Kingdom, M27 4HA|
|Sir James Spence Institute of Child Health|
|Newcastle-Upon-Tyne, England, United Kingdom, NE1 4LP|
|Queen's Medical Centre|
|Nottingham, England, United Kingdom, NG7 2UH|
|Oxford Radcliffe Hospital|
|Oxford, England, United Kingdom, 0X3 9DU|
|Children's Hospital - Sheffield|
|Sheffield, England, United Kingdom, S10 2TH|
|Southampton General Hospital|
|Southampton, England, United Kingdom, SO16 6YD|
|Royal Marsden NHS Foundation Trust - Surrey|
|Sutton, England, United Kingdom, SM2 5PT|
|Royal Belfast Hospital for Sick Children|
|Belfast, Northern Ireland, United Kingdom, BT12 6BE|
|Royal Aberdeen Children's Hospital|
|Aberdeen, Scotland, United Kingdom, AB25 2ZG|
|Royal Hospital for Sick Children|
|Edinburgh, Scotland, United Kingdom, EH9 1LF|
|Royal Hospital for Sick Children|
|Glasgow, Scotland, United Kingdom, G3 8SJ|
|Childrens Hospital for Wales|
|Cardiff, Wales, United Kingdom, CF14 4XW|
|Study Chair:||Colin Kennedy||University Hospital Southampton NHS Foundation Trust|