Trial Information

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

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.