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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | October 1, 2009 | ||||
| Start Date ICMJE | January 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00003772 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Quality-of-Life Assessment in Patients With Ovarian Cancer | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment. PURPOSE: This clinical trial studies the quality of life in patients with ovarian cancer. |
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| Detailed Description | OBJECTIVES: I. Evaluate the scale structure and reliability of the ovarian cancer specific questionnaire module (EORTC QLQ-OV28) designed to be used in conjunction with the standard nonspecific questionnaire (EORTC QLQ-C30) in patients with ovarian epithelial cancer. II. Evaluate the psychometric properties of the revised scales (physical and role functioning; global health status/QL) of the EORTC QLQ-C30 among ovarian cancer patients. III. Evaluate the evidence for the validity of EORTC QLQ-OV28. 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. |
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| Study Phase | |||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | |||||
| Condition ICMJE | Ovarian Cancer | ||||
| Intervention ICMJE | Procedure: quality-of-life assessment | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 280 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Female | ||||
| Ages | |||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Austria, France, Spain, United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00003772 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000066899, EORTC-15982 | ||||
| Study Sponsor ICMJE | European Organization for Research and Treatment of Cancer | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | September 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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