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

Sponsor

Children's Cancer and Leukaemia Group (Other)

Overall Status

Unknown status

CT.gov ID

NCT00278239

Collaborator

(none)

Locations

Study Details

Study Description

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.

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

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 Design

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 :

Jun 1, 2002

Outcome Measures

Primary Outcome Measures

Quality of life (QOL) as measured by QOL questionnaire []

Secondary Outcome Measures

Quality of survival compared among children undergoing different treatments by Health Utilities Index []

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 24 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Surviving primitive neuroectodermal tumor (PNET) patients previously enrolled in International Pediatric Oncology Society (SIOP) 2 or 3 phase III treatment trials
Surviving PNET patients eligible for and treated according to PNET 3 protocol but not randomized
No metastatic disease at time of allocation to treatment
No current progressive disease

PATIENT CHARACTERISTICS:

No patient deemed unsuitable for this study by treating clinician

PRIOR CONCURRENT THERAPY:

Not specified

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Our Lady's Hospital for Sick Children	Dublin		Ireland	12
2	Birmingham Children's Hospital	Birmingham	England	United Kingdom	B4 6NH
3	Institute of Child Health at University of Bristol	Bristol	England	United Kingdom	BS2 8AE
4	Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust	Cambridge	England	United Kingdom	CB2 2QQ
5	Leeds Cancer Centre at St. James's University Hospital	Leeds	England	United Kingdom	LS9 7TF
6	Leicester Royal Infirmary	Leicester	England	United Kingdom	LE1 5WW
7	Royal Liverpool Children's Hospital, Alder Hey	Liverpool	England	United Kingdom	L12 2AP
8	Royal London Hospital	London	England	United Kingdom	E1 1BB
9	Great Ormond Street Hospital for Children NHS Trust	London	England	United Kingdom	WC1N 3JH
10	Central Manchester and Manchester Children's University Hospitals NHS Trust	Manchester	England	United Kingdom	M27 4HA
11	Sir James Spence Institute of Child Health	Newcastle-Upon-Tyne	England	United Kingdom	NE1 4LP
12	Queen's Medical Centre	Nottingham	England	United Kingdom	NG7 2UH
13	Oxford Radcliffe Hospital	Oxford	England	United Kingdom	0X3 9DU
14	Children's Hospital - Sheffield	Sheffield	England	United Kingdom	S10 2TH
15	Southampton General Hospital	Southampton	England	United Kingdom	SO16 6YD
16	Royal Marsden NHS Foundation Trust - Surrey	Sutton	England	United Kingdom	SM2 5PT
17	Royal Belfast Hospital for Sick Children	Belfast	Northern Ireland	United Kingdom	BT12 6BE
18	Royal Aberdeen Children's Hospital	Aberdeen	Scotland	United Kingdom	AB25 2ZG
19	Royal Hospital for Sick Children	Edinburgh	Scotland	United Kingdom	EH9 1LF
20	Royal Hospital for Sick Children	Glasgow	Scotland	United Kingdom	G3 8SJ
21	Childrens Hospital for Wales	Cardiff	Wales	United Kingdom	CF14 4XW