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Sponsored by: |
European Organization for Research and Treatment of Cancer |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00041301 |
RATIONALE: Quality of life assessment in patients undergoing prostate cancer treatment may help determine the intermediate and long-term effects of the treatment on these patients.
PURPOSE: Clinical trial to study the effectiveness of two questionnaires in assessing quality of life of patients who have prostate cancer.
Condition | Intervention |
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Cancer-Related Problem/Condition Prostate Cancer |
Procedure: quality-of-life assessment |
Study Type: | Observational |
Official Title: | An International Field Study Of The Reliability And Validity Of The EORTC QLQ-C30 And A Disease-Specific Questionnaire Module (QLQ-PR25) For Assessing Quality Of Life Of Patients With Prostate Cancer |
Study Start Date: | March 2002 |
OBJECTIVES:
OUTLINE: This is a multicenter study. Patients are stratified according to stage of disease (local or locally advanced disease vs metastatic disease).
Patients complete EORTC QLQ-C30 and prostate cancer-specific QLQ-PR25 questionnaires before therapy and at 3 months after the start of therapy. Patients in stratum II also complete questionnaires at 6 months after the start of therapy.
PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Stratum I:
Clinically localized primary prostate cancer
Local or locally advanced primary prostate cancer
Stratum II:
Metastatic prostate cancer
Plan to receive hormonal treatment
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Investigator: | Neil K. Aaronson, PhD | Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital |
Investigator: | George Van Andel, MD | Onze Lieve Vrouwe Gasthuis |
Study ID Numbers: | CDR0000069463, EORTC-15011, EORTC-30011 |
Study First Received: | July 8, 2002 |
Last Updated: | December 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00041301 |
Health Authority: | United States: Federal Government |
quality of life stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Quality of Life |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |