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Assessing Quality of Life of Patients With Prostate Cancer
The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2004 by National Cancer Institute (NCI).   Recruitment status was  Active, not recruiting

First Received on July 8, 2002.   Last Updated on February 18, 2011   History of Changes
Sponsor: European Organization for Research and Treatment of Cancer - EORTC
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00041301
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2002
Detailed Description:

OBJECTIVES:

  • Assess the scale structure, psychometric validity, and reliability of quality of life measurements using the EORTC QLQ-C30 and the prostate cancer-specific QLQ-PR25 questionnaires in patients with stage I-IV prostate cancer.

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed prostate cancer
  • Stratum I:

    • Clinically localized primary prostate cancer

      • T1-T3, G1-G3, N0, M0
      • Plan to undergo a radical prostatectomy OR
    • Local or locally advanced primary prostate cancer

      • T1-T4, G1-G3, N0, M0
      • Plan to undergo radiotherapy with curative intent
  • Stratum II:

    • Metastatic prostate cancer

      • T1-T4, G1-G3, N1, M0-M1 OR
      • T1-T4, G1-G3, N0-1, M1
      • Plan to receive hormonal treatment

        • No anti-androgen monotherapy
  • No cerebral metastases

PATIENT CHARACTERISTICS:

Age:

  • Any age

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Other:

  • Mentally fit to complete a questionnaire
  • Literate in the language of the questionnaires
  • No psychological, familial, sociological, or geographical condition that would preclude compliance
  • No other concurrent malignancy except basal cell skin cancer
  • No concurrent participation in other quality of life investigations that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • See Disease Characteristics
  • No prior neoadjuvant hormonal treatment
  • Planned adjuvant hormonal therapy (orchiectomy, luteinizing hormone-releasing hormone analogue, or maximal androgen blockade) is allowed for patients in stratum I

Radiotherapy:

  • See Disease Characteristics
  • No interstitial radiotherapy
  • More than 2 years since prior radiotherapy (stratum II)

Surgery:

  • See Disease Characteristics
  • More than 2 years since prior prostatectomy (stratum II)

Other:

  • No prior treatment for prostate carcinoma
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041301

  Show 33 Study Locations
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer - EORTC
Investigators
Investigator: Neil K. Aaronson, PhD Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Investigator: George Van Andel, MD Onze Lieve Vrouwe Gasthuis
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00041301     History of Changes
Other Study ID Numbers: CDR0000069463, EORTC-15011, EORTC-30011
Study First Received: July 8, 2002
Last Updated: February 18, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
stage III prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012