Clinical trial · Observational
Assessing Quality of Life of Patients With Prostate Cancer
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
NCT00041301CI-TRIAL-00007895completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QoL assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- QoL in prostate cancer
- description
- 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.
- interventionNames
- Other: QoL assessment
Primary outcomes (1)
- measure
- psychometric validity of the PR25 module
- timeFrame
- before start of treatment, three months after the start of primary treatment and six months after the start of primary treatment.
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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 carcinomaReferences
Publications (2)
- RESULTArraras JI, Villafranca E, Arias de la Vega F, Romero P, Rico M, Vila M, Asin G, Chicata V, Dominguez MA, Lainez N, Manterola A, Martinez E, Martinez M. The EORTC Quality of Life Questionnaire for patients with prostate cancer: EORTC QLQ-PR25. Validation study for Spanish patients. Clin Transl Oncol. 2009 Mar;11(3):160-4. doi: 10.1007/s12094-009-0332-z. PMID 19293053
- RESULTArraras Urdaniz JI, Villafranca Iturre E, Arias de la Vega F, Dominguez Dominguez MA, Lainez Milagro N, Manterola Burgaleta A, Martinez Lopez E, Romero Rojano P, Martinez Aguillo M. The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients. Arch Esp Urol. 2008 Oct;61(8):949-54. doi: 10.4321/s0004-06142008000800017. PMID 19040169