Quality of Life-Diagnostics and -Therapy in Individual Patients with Breast Cancer.

A randomized study including 200 patients, 5 clinics and 43 general practitioners as coordinating doctors for quality of life therapies.

Condition	Intervention	Phase
Breast Neoplasms	Behavior: physio,pain,psychotherapy;social,nutrit.counselling&sports	Phase I Phase II

Further Study Details: 

Primary Outcomes: amount of QL-deficits at the end of the study period
Expected Total Enrollment:  200

Quality of life (QL) is increasingly being accepted as an important endpoint in clinical studies, however little is known about its diagnostic value in order to optimize the therapy of cancer patients. This project at the Tumorcentre Regensburg aims to integrate QL-diagnostics into the therapy of patients with breast cancer and to evaluate the efficacy of QL-diagnostics in the context of a randomized clinical trial.

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

Criteria

Inclusion Criteria:

• All patients with primary breast cancer in the county of Regensburg, Amberg and Sulzbach-Rosenberg from November 2004 to approximately June 2006 submitted by coordinating physicians who were trained in quality of life questionnaires and profiles

Exclusion Criteria:

• Secondary breast cancer, patients who refused to participate, patients incapable of filling out questionnaires, male patients, pregnant patients, age below 18 yrs.

Please refer to this study by ClinicalTrials.gov identifier  NCT00145743

Monika KS Klinkhammer-Schalke, MD      +49-941-943  Ext. 1803    monika.schalke@klinik.uni-regensburg.de
Wilfried WL Lorenz, MD, Prof.      +49-941-943  Ext. 4092    wilfried.lorenz@klinik.uni-regensburg.de

Germany, Bavaria
      Tumorzentrum Regensburg, Regensburg,  Bavaria,  93053,  Germany; Recruiting

Study chairs or principal investigators

Monika KS Klinkhammer-Schalke, MD,  Study Chair,  Tumorzentrum Regensburg e.V.   
Michael MK Koller, Ph.D.,  Principal Investigator,  University of Marburg, Institut of Theoretical Surgery   
Brigitte BE Ernst, MD,  Principal Investigator,  General Practitioner, Bad Abbach   
Ferdinand FH Hofstädter, MD, Prof.,  Principal Investigator,  Tumorzentrum Regensburg e.V.   
Wilfried WL Lorenz, MD, Prof.,  Principal Investigator,  Tumorzentrum Regensburg e.V.   

Study ID Numbers:  TUZ-QL-RS-04; 3.5/8203-1/117/02
Last Updated:  September 2, 2005
Record first received:  September 1, 2005
ClinicalTrials.gov Identifier:  NCT00145743
Health Authority: Germany: Ethics Commission
ClinicalTrials.gov processed this record on 2005-09-06