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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00041301 |
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Date of registration:
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08/07/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Assessing Quality of Life of Patients With Prostate Cancer
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Scientific 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 |
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Date of first enrolment:
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March 2002 |
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Target sample size:
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625 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00041301 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Australia
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Belgium
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Denmark
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France
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Germany
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Italy
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Netherlands
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Norway
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Romania
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Turkey
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United Kingdom
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Contacts
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Name:
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Neil K. Aaronson, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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The Netherlands Cancer Institute |
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Name:
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George Van Andel, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Onze Lieve Vrouwe Gasthuis |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Other: QoL assessment
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Primary Outcome(s)
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psychometric validity of the PR25 module
[Time Frame: before start of treatment, three months after the start of primary treatment and six months after the start of primary treatment.]
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Secondary Outcome(s)
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debriefing questionnaire information
[Time Frame: at baseline]
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Secondary ID(s)
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EORTC-15011
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EORTC-15011-30011
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EORTC-30011
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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