Prostate Cancer
Conditions
Keywords
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
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.
Detailed description
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.
Interventions
OTHERQoL assessment
qol questionnaires
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| psychometric validity of the PR25 module | 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
| Measure | Time frame | Description |
|---|---|---|
| debriefing questionnaire information | 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. |
Countries
Australia, Belgium, Denmark, France, Germany, Italy, Netherlands, Norway, Romania, Turkey (Türkiye), United Kingdom
Outcome results
None listed