Quality-of-Life Assessment in Patients With Ovarian Cancer
NCT ID: NCT00003772
Last Updated: 2012-08-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
372 participants
OBSERVATIONAL
1999-01-31
2003-02-28
Brief Summary
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PURPOSE: This clinical trial studies the quality of life in patients with ovarian cancer.
Detailed Description
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OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy and disease. Questionnaires are designed to be completed by patients themselves without help. Patients complete the EORTC QLQ-C30, QLQ-OV28, and a debriefing questionnaire regarding time to completion and patient's reaction to the quality of life questionnaires according to one of the following schedules: Group 1: Patients complete the questionnaires once prior to the start of the first course of chemotherapy, and again on the first day of the third course of chemotherapy. Group 2: Patients complete the questionnaires once 1 to 8 weeks following completion of the 6th course of chemotherapy and prior to any further anticancer therapy. Group 3: Patients complete the questionnaires once at a routine follow-up clinic visit and again at home within 3 days of the clinic visit. Group 4: Patients complete the questionnaires once prior to the first course of chemotherapy and again on the first day of the 3rd course of chemotherapy prior to administration OR at the first clinical review following 2 courses of chemotherapy OR 2 months later for patients receiving continuous or weekly chemotherapy. If they are unable to complete written questionnaires due to physical limitations or illiteracy, or if they express a strong preference for oral administration, patients in Groups 1, 2, and 4 may complete the questionnaires orally instead.
PROJECTED ACCRUAL: A minimum of 280 patients will be accrued for this study within 2 years.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
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
18 Years
FEMALE
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Ann Cull, PhD
Role: STUDY_CHAIR
Edinburgh Cancer Centre at Western General Hospital
Locations
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Landeskrankenhaus/Universitatskliniken Graz
Graz, , Austria
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Hospital De Navarra
Pamplona, , Spain
Western General Hospital
Edinburgh, Scotland, United Kingdom
Countries
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References
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Chie WC, Tsai CJ, Chiang C, Lee YC. Quality of life of patients with oesophageal cancer in Taiwan: validation and application of the Taiwan Chinese (Mandarin) version of the EORTC QLQ-OES18: a brief communication. Qual Life Res. 2010 Oct;19(8):1127-31. doi: 10.1007/s11136-010-9675-8. Epub 2010 May 22.
Cull A, Howat S, Greimel E, Waldenstrom AC, Arraras J, Kudelka A, Chauvenet L, Gould A; EORTC Quality of Life Group [European Organization for Research and Treatment of Cancer]; Scottish Gynaecological Cancer Trials Group. Development of a European Organization for Research and Treatment of Cancer questionnaire module to assess the quality of life of ovarian cancer patients in clinical trials: a progress report. Eur J Cancer. 2001 Jan;37(1):47-53. doi: 10.1016/s0959-8049(00)00369-5.
Other Identifiers
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EORTC-15982
Identifier Type: OTHER
Identifier Source: secondary_id
EORTC-15982
Identifier Type: -
Identifier Source: org_study_id