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Home > "A" Clinical Trials Conditions > Assessing Quality of Life of Patients With Prostate Cancer  Assessing Quality of Life of Patients With Prostate Cancer
Assessing Quality of Life of Patients With Prostate Cancer
For Condition: Quality of Life,stage 1 prostate cancer,stage 2 prostate cancer,stage 3 prostate cancer,stage 4 prostate cancer
Status: Recruiting
Sponsor(s): EORTC Quality of Life Study Group , EORTC Genito-Urinary Tract Cancer Cooperative Group
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeAndel, , Onze Lieve Vrouwe Gasthuis
Onze Lieve Vrouwe Gasthuis *Recruiting*
Amsterdam, , 1091 HA
Netherlands
Recruiting Contact Person 31-20-599-9111
Universitair Ziekenhuis Gent *Recruiting*
Ghent, , B-9000
Belgium
Recruiting Contact Person 32-92-240-2011
Rigshospitalet *Recruiting*
Copenhagen, , 2100
Denmark
Recruiting Contact Person 45-3-545-4286
U.Z. Gasthuisberg *Recruiting*
Leuven, , B-3000
Belgium
Recruiting Contact Person 32-16-33-2211
Velindre Cancer Center at Velinde Hospital *Recruiting*
Cardiff, Wales, CF14 2TL
United Kingdom
Recruiting Contact Person 44-29-2061-5888
Groot Ziekengasthuis 's-Hertogenbosch *Recruiting*
's-Hertogenbosch, , 5211 NL
Netherlands
Recruiting Contact Person 31-73-611-2446
Marmara University Hospital *Recruiting*
Istanbul, , 81190
Turkey
Recruiting Contact Person 90-212-327-5050
Academisch Medisch Centrum *Recruiting*
Amsterdam, , 1105 AZ
Netherlands
Recruiting Contact Person 31-20-566-9111
Rijnstate Hospital *Recruiting*
ARNHEM, , 6800 TA
Netherlands
Recruiting Contact Person 31-26-378-8888
Virga Jesse Hospital *Recruiting*
Hasselt, , 3500
Belgium
Recruiting Contact Person 32-11-30-9990
Cazk Groeninghe - Campus Maria's Voorzienigheid *Recruiting*
Kortrijk, , B-8500
Belgium
Recruiting Contact Person 32-56-366-111
Spedali Civili *Recruiting*
Brescia, , 25124
Italy
Recruiting Contact Person 39-3-995-483
University Hospital - Rotterdam Dijkzigt *Recruiting*
Rotterdam, , 3000 CA
Netherlands
Recruiting Contact Person 31-10-463-9222
St. Elisabeth Ziekenhuis *Recruiting*
Tilburg, , 5022 GC
Netherlands
Recruiting Contact Person 31-13-539-1313
Institute of Oncology - Bucarest *Recruiting*
Bucarest, , RO 72435
Romania
Recruiting Contact Person 40-1-240-8764
Sir Charles Gairdner Hospital - Perth *Recruiting*
Perth, Western Australia, 6009
Australia
Recruiting Contact Person 61-8-9346-3841
Hopital Jean Bernard *Recruiting*
Poitiers, , 86021
France
Recruiting Contact Person 33-5-4944-4444
Universitaets-Krankenhaus Eppendorf *Recruiting*
Hamburg, , D-20246
Germany
Recruiting Contact Person 49-40-428-030
Ospedale S. Giovanni Battista *Recruiting*
Torino, , 10126
Italy
Recruiting Contact Person 39-06-6566
Azienda Ospedaliera Maggiore Della Carita *Recruiting*
Novara, , 28100
Italy
Recruiting Contact Person 39-321-373-3282
Academisch Ziekenhuis Groningen *Recruiting*
Groningen, , 9713 GZ
Netherlands
Recruiting Contact Person 31-50-361-6161
Inselspital, Bern *Recruiting*
Bucarest, , RO 72435
Romania
Recruiting Contact Person 41-31-632-2111
Cliniques Universitaires Saint-Luc *Recruiting*
Brussels, , 1200
Belgium
Recruiting Contact Person 32-2-764-1111
University of Wales College of Medicine *Recruiting*
Cardiff, Wales, CF14 4XN
United Kingdom
Recruiting Contact Person 44-29-2074-7747
Daniel Den Hoed Cancer Center at Erasmus Medical Center *Recruiting*
Rotterdam, , 3008 AE
Netherlands
Recruiting Contact Person 31-10-439-1911
University Medical Center Nijmegen *Recruiting*
Nijmegen, , NL-6500 HB
Netherlands
Recruiting Contact Person 31-24-361-1111
Universita di Palermo *Recruiting*
Palermo, , 90141
Italy
Recruiting Contact Person 39-91-625-5292
Academisch Ziekenhuis der Vrije Universiteit Brussel *Recruiting*
Brussels, , 1090
Belgium
Recruiting Contact Person 32-3-477-6040
Istituto Scientifico H.San Raffaele *Recruiting*
Milano, , 20132
Italy
Recruiting Contact Person 39-2-643-2653
Universitaetsklinikum Bonn *Recruiting*
Bonn, , D-53105
Germany
Recruiting Contact Person 49-228-280-3816
Dokuz Eylul University School of Medicine *Recruiting*
Izmir, , 35340
Turkey
Recruiting Contact Person 90-232-259-8773
Bristol Haematology and Oncology Centre *Recruiting*
Bristol, England, BS2 8ED
United Kingdom
Recruiting Contact Person 44-117-923-0000
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Contact Person 47-22-93-4000
Additional Information:
Study ID Numbers: CDR0000069463; EORTC-30011,EORTC-15011
Study Start Date:
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00041301
Other Stage 4 Prostate Cancer Studies:
1. Radiation Therapy and Cisplatin With or Without Epoetin Alfa in Treating Patients With Cervical Cancer and Anemia
2. Amifostine in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer
3. Radiation Therapy to Relieve Symptoms in Patients With Non-small Cell Lung Cancer
4. Survival TRaining for ENhancing Total Health (STRENGTH): Distance Medicine-Based Exercise and Diet in Preventing Body Composition Change in Patients Receiving Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer
5. ZD1839 Plus Chemotherapy in Treating Patients With Non-Small Cell Lung Cancer
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Assessing Quality of Life of Patients With Prostate Cancer
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