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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00041301




Registration number
NCT00041301
Ethics application status
Date submitted
8/07/2002
Date registered
27/01/2003
Date last updated
27/08/2012

Titles & IDs
Public title
Assessing Quality of Life of Patients With Prostate Cancer
Scientific title
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
Secondary ID [1] 0 0
EORTC-15011
Secondary ID [2] 0 0
EORTC-15011-30011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - QoL assessment

QoL in prostate cancer - 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 interventions: QoL assessment
qol questionnaires

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
before start of treatment, three months after the start of primary treatment and six months after the start of primary treatment.
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
at baseline

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Sir Charles Gairdner Hospital - Perth - Perth
Recruitment postcode(s) [1] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Brussels
Country [2] 0 0
Belgium
State/province [2] 0 0
Ghent
Country [3] 0 0
Belgium
State/province [3] 0 0
Hasselt
Country [4] 0 0
Belgium
State/province [4] 0 0
Kortrijk
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Denmark
State/province [6] 0 0
Copenhagen
Country [7] 0 0
France
State/province [7] 0 0
Poitiers
Country [8] 0 0
Germany
State/province [8] 0 0
Bonn
Country [9] 0 0
Germany
State/province [9] 0 0
Hamburg
Country [10] 0 0
Italy
State/province [10] 0 0
Brescia
Country [11] 0 0
Italy
State/province [11] 0 0
Milano
Country [12] 0 0
Italy
State/province [12] 0 0
Novara
Country [13] 0 0
Italy
State/province [13] 0 0
Palermo
Country [14] 0 0
Italy
State/province [14] 0 0
Torino
Country [15] 0 0
Netherlands
State/province [15] 0 0
's-Hertogenbosch
Country [16] 0 0
Netherlands
State/province [16] 0 0
Amsterdam
Country [17] 0 0
Netherlands
State/province [17] 0 0
Arnhem
Country [18] 0 0
Netherlands
State/province [18] 0 0
Groningen
Country [19] 0 0
Netherlands
State/province [19] 0 0
Nijmegen
Country [20] 0 0
Netherlands
State/province [20] 0 0
Rotterdam
Country [21] 0 0
Netherlands
State/province [21] 0 0
Tilburg
Country [22] 0 0
Norway
State/province [22] 0 0
Oslo
Country [23] 0 0
Romania
State/province [23] 0 0
Bucarest
Country [24] 0 0
Turkey
State/province [24] 0 0
Istanbul
Country [25] 0 0
Turkey
State/province [25] 0 0
Izmir
Country [26] 0 0
United Kingdom
State/province [26] 0 0
England
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Wales

Funding & Sponsors
Primary sponsor type
Other
Name
European Organisation for Research and Treatment of Cancer - EORTC
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00041301
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Neil K. Aaronson, PhD
Address 0 0
The Netherlands Cancer Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications