Assessing Quality of Life of Patients With Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: QoL assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| QoL in prostate cancer<br>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<br>* qol questionnaires<br>* Other names: QLQ-PR25;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychometric validity of the PR25 module | 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. | before start of treatment, three months after the start of primary treatment and six months after the start of primary treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| debriefing questionnaire information | 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. | at baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer