Diagnostics and Therapy of Disease-Related Quality of Life of Patients With Breast Cancer
NCT ID: NCT00145743
Last Updated: 2007-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
200 participants
INTERVENTIONAL
2004-11-30
2007-10-31
Brief Summary
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A randomized study including 200 patients, 5 clinics and 43 general practitioners as coordinating doctors for quality of life therapies.
Detailed Description
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The Tumorcentre Regensburg provides the infrastructure of the present project (telemedicine, project groups, quality circle). Breast cancer patients' therapy is based on the recent national breast cancer therapy guideline, including assorted QL-enhancing therapy options, such as pain therapy, physiotherapy and lymphatic drainage, psychotherapy, social counseling and rehabilitation, nutrition and sports.
In the course of an implementation phase, a new method of QL diagnostics has been developed. Five experts with varying professional background use the individual patient's QL profile and clinical and sociodemographic information in order to generate a QL-report including a therapy recommendation.
This is a two-arm randomized clinical trial with one test group (communication of the QL-finding to the coordinating physician) and a control group (no communication). Patients with newly diagnosed breast cancer who are treated in the study region by one of the coordinating doctors will be included in this randomized study. QL-assessments (EORTC QLQ-C30 plus BR23) will be taken at designated points in time over a 12 months time course. Finally, patients will provide an overall evaluation of the course and the effects of the therapy using an open-ended questionnaire.
We expect that patients in the test group will experience a lower number of QL-deficits at the end of the study period (Median 1 +/- 2) than patients of the control group (Median 2 +/- 2). The statistical confirmation of this expected effect requires a total sample size of N = 200 (n=100 vs. n=100, alpha = 5% \[two-tailed\], beta = 10%).
This is the first study to evaluate a new form of QL-diagnostics in the complexity of a real patient care environment. This study promises to reveal important new insights into advanced patient care and will make the inclusion of the quality of life concept in the current breast cancer treatment guideline more concrete.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Patient's reported questionaire, profile in 10 dimensions (EORTC) and referees' report with treatment recommendations
physio,pain,psychotherapy;social,nutrit.counselling&sports
profile and treatment recommendations based on the profile vs. routine psychooncology
2
Patient's reported questionaire; no recommendations given
physio,pain,psychotherapy;social,nutrit.counselling&sports
profile and treatment recommendations based on the profile vs. routine psychooncology
Interventions
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physio,pain,psychotherapy;social,nutrit.counselling&sports
profile and treatment recommendations based on the profile vs. routine psychooncology
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Tumor Center Regensburg
OTHER
Principal Investigators
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Monika KS Klinkhammer-Schalke, MD
Role: STUDY_CHAIR
Tumor Center Regensburg
Michael MK Koller, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Marburg, Institut of Theoretical Surgery
Brigitte BE Ernst, MD
Role: PRINCIPAL_INVESTIGATOR
General Practitioner, Bad Abbach
Ferdinand FH Hofstädter, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Tumor Center Regensburg
Wilfried WL Lorenz, MD, Prof.
Role: PRINCIPAL_INVESTIGATOR
Tumor Center Regensburg
Locations
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Tumorzentrum Regensburg
Regensburg, Bavaria, Germany
Countries
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References
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Koller M, Lorenz W. Quality of life: a deconstruction for clinicians. J R Soc Med. 2002 Oct;95(10):481-8. doi: 10.1177/014107680209501002. No abstract available.
Related Links
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Related Info
Other Identifiers
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3.5/8203-1/117/02
Identifier Type: -
Identifier Source: secondary_id
TUZ-QL-RS-04
Identifier Type: -
Identifier Source: org_study_id