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Quality-of-Life Assessment in Patients With Ovarian Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003772
First Posted: March 15, 2004
Last Update Posted: August 27, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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 ( Other Identifier: EORTC )
First Submitted: November 1, 1999
First Posted: March 15, 2004
Last Update Posted: August 27, 2012
Last Verified: August 2012

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