Assessing Quality of Life of Patients With Prostate Cancer

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. Identifier: NCT00041301
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : August 27, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

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 or disease Intervention/treatment
Prostate Cancer Other: QoL assessment

Detailed Description:


  • 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.

Study Type : Observational
Actual Enrollment : 625 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Primary Completion Date : December 2004
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Group/Cohort Intervention/treatment
QoL in prostate cancer
The study sample will be composed of a consecutive series of prostate cancer patients, stratified by stage of disease, local and locally advanced versus advanced (metastatic) disease, and undergoing active anti-tumor therapy. In order to increase sample homogeneity, and to facilitate evaluation of the responsiveness of the quality of life instruments to changes in patients' health status and symptoms experience over time, the subsample of patients with local or locally advanced disease will be restricted to those undergoing surgery (radical prostatectomy) or radiation therapy, and the subsample of metastatic disease patients will be limited to those receiving hormonal therapy.
Other: QoL assessment
qol questionnaires
Other Names:
  • QLQ-C30
  • QLQ-PR25

Primary Outcome Measures :
  1. psychometric validity of the PR25 module [ Time Frame: before start of treatment, three months after the start of primary treatment and six months after the start of primary treatment. ]

    Quality of life scores will be evaluated for psychometric validity by:

    • Scale structure using multi-trait scaling analysis
    • Reliability using tests of internal consistency
    • Test-retest reliability
    • Validity using inter-scale correlations and known group comparisons
    • Sensitivity to change using two measurements of Quality of Life and ANOVA to look for the significance of changes in quality of life scores as a function of observed changes in clinical status over time.

Secondary Outcome Measures :
  1. debriefing questionnaire information [ Time Frame: at baseline ]
    Patients will be asked to complete a short debriefing questionnaire covering questions about the time taken to complete the EORTC QLQ-C30 and QLQ-PR25; the need for help in completing the questionnaires and querying whether any of the questionnaire items were confusing; difficult to answer or upsetting.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prostate cancer


  • 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



  • Any age

Performance status:

  • Not specified

Life expectancy:

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • 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


Biologic therapy:

  • Not specified


  • 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


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


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


  • No prior treatment for prostate carcinoma

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 identifier (NCT number): NCT00041301

  Show 33 Study Locations
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Neil K. Aaronson, PhD The Netherlands Cancer Institute
Principal Investigator: George Van Andel, MD Onze Lieve Vrouwe Gasthuis

Publications of Results:
Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00041301     History of Changes
Other Study ID Numbers: EORTC-15011-30011
EORTC-15011 ( Other Identifier: EORTC )
EORTC-30011 ( Other Identifier: EORTC )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 27, 2012
Last Verified: August 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
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
Genital Diseases, Male
Prostatic Diseases