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

Primary Purpose

Brain and Central Nervous System Tumors, Cognitive/Functional Effects, Long-term Effects Secondary to Cancer Therapy in Children

Status
Unknown status
Phase
Locations
International
Study Type
Observational
Intervention
cognitive assessment
psychosocial assessment and care
quality-of-life assessment
Sponsored by
Children's Cancer and Leukaemia Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Brain and Central Nervous System Tumors focused on measuring long-term effects secondary to cancer therapy in children, psychosocial effects of cancer and its treatment, cognitive/functional effects, childhood supratentorial primitive neuroectodermal tumor

Eligibility Criteria

3 Years - 24 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Our Lady's Hospital for Sick Children
  • Birmingham Children's Hospital
  • Institute of Child Health at University of Bristol
  • Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
  • Leeds Cancer Centre at St. James's University Hospital
  • Leicester Royal Infirmary
  • Royal Liverpool Children's Hospital, Alder Hey
  • Royal London Hospital
  • Great Ormond Street Hospital for Children NHS Trust
  • Central Manchester and Manchester Children's University Hospitals NHS Trust
  • Sir James Spence Institute of Child Health
  • Queen's Medical Centre
  • Oxford Radcliffe Hospital
  • Children's Hospital - Sheffield
  • Southampton General Hospital
  • Royal Marsden NHS Foundation Trust - Surrey
  • Royal Belfast Hospital for Sick Children
  • Royal Aberdeen Children's Hospital
  • Royal Hospital for Sick Children
  • Royal Hospital for Sick Children
  • Childrens Hospital for Wales

Outcomes

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

Full Information

First Posted
January 16, 2006
Last Updated
September 19, 2013
Sponsor
Children's Cancer and Leukaemia Group
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1. Study Identification

Unique Protocol Identification Number
NCT00278239
Brief Title
Quality of Life in Patients Who Have Undergone Previous Treatment for Primitive Neuroectodermal Tumors
Official Title
Study of Outcome of Children Previously Enrolled in European Trials of Treatment for Primitive Neuroectodermal Tumour (PNET)
Study Type
Observational

2. Study Status

Record Verification Date
April 2006
Overall Recruitment Status
Unknown status
Study Start Date
June 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Children's Cancer and Leukaemia Group

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
long-term effects secondary to cancer therapy in children, psychosocial effects of cancer and its treatment, cognitive/functional effects, childhood supratentorial primitive neuroectodermal tumor

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
cognitive assessment
Intervention Type
Procedure
Intervention Name(s)
psychosocial assessment and care
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Primary Outcome Measure Information:
Title
Quality of life (QOL) as measured by QOL questionnaire
Secondary Outcome Measure Information:
Title
Quality of survival compared among children undergoing different treatments by Health Utilities Index

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
24 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin Kennedy
Organizational Affiliation
University Hospital Southampton NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Our Lady's Hospital for Sick Children
City
Dublin
ZIP/Postal Code
12
Country
Ireland
Facility Name
Birmingham Children's Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Institute of Child Health at University of Bristol
City
Bristol
State/Province
England
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Facility Name
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
Leeds Cancer Centre at St. James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool Children's Hospital, Alder Hey
City
Liverpool
State/Province
England
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Royal London Hospital
City
London
State/Province
England
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Great Ormond Street Hospital for Children NHS Trust
City
London
State/Province
England
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Central Manchester and Manchester Children's University Hospitals NHS Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Facility Name
Sir James Spence Institute of Child Health
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Queen's Medical Centre
City
Nottingham
State/Province
England
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Oxford Radcliffe Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
0X3 9DU
Country
United Kingdom
Facility Name
Children's Hospital - Sheffield
City
Sheffield
State/Province
England
ZIP/Postal Code
S10 2TH
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Royal Belfast Hospital for Sick Children
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT12 6BE
Country
United Kingdom
Facility Name
Royal Aberdeen Children's Hospital
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZG
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH9 1LF
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Childrens Hospital for Wales
City
Cardiff
State/Province
Wales
ZIP/Postal Code
CF14 4XW
Country
United Kingdom

12. IPD Sharing Statement

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

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