Quality of Life in Patients Who Have Undergone Previous Treatment for Primitive Neuroectodermal Tumors

• Conditions: 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

• Registration Number: NCT00278239
• Lead Sponsor: Children's Cancer and Leukaemia Group

Brief Summary

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.

Detailed Description

OBJECTIVES:

Primary

* 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.

Secondary

* 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 Timeline

• Study Start: 2002-06
• Study First Submitted: 2006-01-16
• Study First Submitted QC: 2006-01-16
• Study First Posted: 2006-01-18
• Status Verified: 2006-04
• Last Update Submitted: 2013-09-19
• Last Update Posted: 2013-09-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of life (QOL) as measured by QOL questionnaire

Secondary Outcome Measures

Name	Time	Method
Quality of survival compared among children undergoing different treatments by Health Utilities Index

Trial Locations

Locations (20)

Royal Aberdeen Children's Hospital; 🇬🇧 Aberdeen, Scotland, United Kingdom

Sir James Spence Institute of Child Health; 🇬🇧 Newcastle-Upon-Tyne, England, United Kingdom

Central Manchester and Manchester Children's University Hospitals NHS Trust; 🇬🇧 Manchester, England, United Kingdom

Queen's Medical Centre; 🇬🇧 Nottingham, England, United Kingdom

Royal Marsden NHS Foundation Trust - Surrey; 🇬🇧 Sutton, England, United Kingdom

Our Lady's Hospital for Sick Children; 🇮🇪 Dublin, Ireland

Birmingham Children's Hospital; 🇬🇧 Birmingham, England, United Kingdom

Oxford Radcliffe Hospital; 🇬🇧 Oxford, England, United Kingdom

Royal Liverpool Children's Hospital, Alder Hey; 🇬🇧 Liverpool, England, United Kingdom

Children's Hospital - Sheffield; 🇬🇧 Sheffield, England, United Kingdom

Royal Hospital for Sick Children; 🇬🇧 Glasgow, Scotland, United Kingdom

Royal London Hospital; 🇬🇧 London, England, United Kingdom

Childrens Hospital for Wales; 🇬🇧 Cardiff, Wales, United Kingdom

Great Ormond Street Hospital for Children NHS Trust; 🇬🇧 London, England, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, England, United Kingdom

Leeds Cancer Centre at St. James's University Hospital; 🇬🇧 Leeds, England, United Kingdom

Leicester Royal Infirmary; 🇬🇧 Leicester, England, United Kingdom

Royal Belfast Hospital for Sick Children; 🇬🇧 Belfast, Northern Ireland, United Kingdom

Institute of Child Health at University of Bristol; 🇬🇧 Bristol, England, United Kingdom

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, England, United Kingdom