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Completed

NCT Number: NCT00041301

Assessing Quality of Life of Patients With Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Sir Charles Gairdner Hospital - Perth, Perth, Western Australia, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QoL assessment

Other

qol questionnaires

Other names: QLQ-C30, QLQ-PR25

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2004
Study completion
2005
First posted
Jan 27, 2003
Registry last updated
Aug 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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