Quality-of-Life Assessment in Patients With Ovarian Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00003772
First received: November 1, 1999
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Ovarian Cancer
Procedure: quality-of-life assessment

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 372
Study Start Date: January 1999
Study Completion Date: February 2003
Primary Completion Date: August 2001 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ovarian cancer

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003772

Locations
Austria
Landeskrankenhaus/Universitatskliniken Graz
Graz, Austria, A-8036
France
Centre Alexis Vautrin
Vandoeuvre-les-Nancy, France, 54511
Spain
Hospital De Navarra
Pamplona, Spain, 31080
United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 9NQ
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Investigators
Study Chair: Ann Cull, PhD Edinburgh Cancer Centre at Western General Hospital
  More Information

Additional Information:
Publications:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00003772     History of Changes
Other Study ID Numbers: EORTC-15982, EORTC-15982
Study First Received: November 1, 1999
Last Updated: August 24, 2012
Health Authority: United States: Federal Government

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
stage I ovarian epithelial cancer
stage II ovarian epithelial cancer
stage III ovarian epithelial cancer
stage IV ovarian epithelial cancer
recurrent ovarian epithelial cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

ClinicalTrials.gov processed this record on July 26, 2014