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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00003772
Date of registration: 01/11/1999
Prospective Registration: No
Primary sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Public title: Quality-of-Life Assessment in Patients With Ovarian Cancer
Scientific title: An International Field Study of the Reliability and Validity of a Disease-Specific Questionnaire Module (the QLQ-OV28) in Assessing the Quality of Life of Patients With Ovarian Cancer
Date of first enrolment: January 1999
Target sample size: 372
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00003772
Study type:  Observational
Study design:  Observational Model: Case-Only, Time Perspective: Prospective  
Phase:  N/A
Countries of recruitment
Austria France Spain United Kingdom
Contacts
Name:     Ann Cull, PhD
Address: 
Telephone:
Email:
Affiliation:  Edinburgh Cancer Centre at Western General Hospital
Key inclusion & exclusion criteria

DISEASE CHARACTERISTICS: Diagnosis of ovarian epithelial carcinoma No prior participation
in this study as a member of a different group Group 1: Prior surgery required Scheduled
for first line chemotherapy No chemotherapy prior to surgery Group 2: Prior surgery
required Completion of 6 courses of first line platinum-based chemotherapy required within
8 weeks prior to study Group 3: Must have achieved complete response to first line therapy
At least 3 months since any therapy for cancer Prior surgery required Prior chemotherapy
allowed Prior radiotherapy allowed Group 4: Must have recurrent disease Scheduled for
chemotherapy Prior surgery required Prior chemotherapy allowed Prior radiotherapy allowed

PATIENT CHARACTERISTICS: Age: Any age Performance status: Not specified Life expectancy:
At least 3 months Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Other: No concurrent malignancies except basal cell carcinoma of the skin No mental
disease or language barrier that would prevent compliance No concurrent participation in
any other quality of life study that might interfere with this study

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease
Characteristics Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics
Surgery: See Disease Characteristics



Age minimum: 18 Years
Age maximum: N/A
Gender: Female
Health Condition(s) or Problem(s) studied
Ovarian Cancer
Intervention(s)
Procedure: quality-of-life assessment
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
EORTC-15982
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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