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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


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

psychometric validity of the PR25 module

Outcome Description:

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.

Outcome Time Frame:

before start of treatment, three months after the start of primary treatment and six months after the start of primary treatment.

Safety Issue:

No

Principal Investigator

Neil K. Aaronson, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Netherlands Cancer Institute

Authority:

United States: Federal Government

Study ID:

EORTC-15011-30011

NCT ID:

NCT00041301

Start Date:

March 2002

Completion Date:

November 2005

Related Keywords:

  • Prostate Cancer
  • stage I prostate cancer
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

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