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Quality-of-Life Assessment in Patients With Ovarian Cancer



Quality-of-Life Assessment in Patients With Ovarian Cancer

For Condition: stage 3 ovarian epithelial cancer,stage 2 ovarian epithelial cancer,Quality of Life,stage 1 ovarian epithelial cancer,stage 4 ovarian epithelial cancer,recurrent ovarian epithelial cancer
Status: No longer recruiting
Sponsor(s): EORTC Quality of Life Study Group ,
Synopsis: RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment. PURPOSE: Clinical trial to assess the quality of life in patients who have ovarian cancer.
Details: 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. PROTOCOL 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.
Eligibility:
Study Type:
  Observational, Defined Population
Minimum Age/Maximum Age: /
Genders: 
Protocol Entry Criteria: PROTOCOL ENTRY 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 --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics - Endocrine therapy: Not specified - Radiotherapy: See Disease Characteristics - Surgery: See Disease Characteristics --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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AnnCull,  Study Chair,  EORTC Quality of Life Study Group

Hospital De Navarra
Pamplona,  ,  31080
Spain
 

Western General Hospital
Edinburgh,  Scotland,  EH4 9NQ
United Kingdom
 

Landeskrankenhaus/Universitatskliniken Graz
Graz,  ,  A-8036
Austria
 

Centre Alexis Vautrin
Vandoeuvre-les-Nancy,  ,  54511
France
 


Additional Information:
Study ID Numbers:
  CDR0000066899;  EORTC-15982
Study Start Date: January 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003772

Other Stage 2 Ovarian Epithelial Cancer Studies:
1. BMS-247550 in Treating Patients With Relapsed and/or Refractory Stage III or Stage IV Ovarian Epithelial or Primary Peritoneal Cancer

2. Vaccine Therapy in Treating Patients With Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

3. Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors

4. Comparison of Combination Chemotherapy Regimens in Treating Newly Diagnosed Ovarian Epithelial Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

5. UCN-01 and Topotecan in Treating Patients With Recurrent, Persistent, or Progressive Advanced Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer

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Quality-of-Life Assessment in Patients With Ovarian Cancer

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