Implementation and Evaluation of Implementation of Quality of Life Diagnostics and Therapy in Individual Patients with Breast Cancer. A prospective study including 170 patients, 5 clinics and 38 general practitioners as coordinating doctors for quality of life therapies. Correlational study including several comparisons such as patients and their doctors.

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

Further Study Details: 

Expected Total Enrollment:  190

Improving cancer patients'''' quality of life (QL) requires that QL-diagnostics, the availability of QL-enhancing treatment options and treatment decisions are being integrated into a clinical path. This description presents the development and implementation of such a clinical path in the Tumorcenter Regensburg.

The acting persons and institutions in this clinical path are the breast cancer patients, the hospitals, the family doctors or gynaecologists, and a QL-study team. Starting point is the QL-assessment either in the hospital or in doctors'''' practice (EORTC QLQ-C30 plus BR-23). The caring physician documents the patients'''' health status. Based on these two pieces of information, the QL-study team writes up a medical/QL-opinion plus therapy recommendation. This report is sent to the caring physician. The effectiveness of the therapy recommendation is assessed in the following QL-assessment. This clinical path is implemented via three interrelated methods of implementation: local opinion leaders, outreach visits, and quality circle.

A total of 38 physicians were made familiar with QL-diagnostics through outreach visits, and 12 opinion leaders were identified and convinced to support this project. The quality circle provided regular CME meetings on QL-enhancing therapy options (pain control, psychotherapy, physiotherapy, nutrition, social rehabilitation). A total of 170 QL-reports were sent to physicians. All 38 doctors found the QL-profiles comprehensible and the therapy recommendations clinically relevant. The most common QL-problems were emotional functioning, fatigue, and arm/shoulder problems.

QL-diagnostics is a new way to individualise and to rationalise patient care. It transforms the QL-concept into a decision-relevant, integral part of a clinical path that aims to provide high quality patient care.

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 in the year 2003 to June 2004 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.

Germany, Bavaria
      Tumorzentrum Regensburg, Regensburg,  Bavaria,  93053,  Germany

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-IP-03; 3.5/8203-1/117/02
Last Updated:  August 31, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00141635
Health Authority: Germany: Ethics Commission
ClinicalTrials.gov processed this record on 2005-09-13