Quality-of-Life Assessment in Patients With Ovarian Cancer
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official 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|
|Study Start Date:||January 1999|
|Study Completion Date:||February 2003|
|Primary Completion Date:||August 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003772
|Graz, Austria, A-8036|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Hospital De Navarra|
|Pamplona, Spain, 31080|
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 9NQ|
|Study Chair:||Ann Cull, PhD||Edinburgh Cancer Centre at Western General Hospital|