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Implementation of Quality of Life Diagnostics and Therapy

This study has been completed.
Information provided by:
Tumorzentrum Regensburg e.V. Identifier:
First received: August 31, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
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 Behavioral: physio,pain,psychotherapy;social,nutrit.counselling&sports Phase 1

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: Enhancing the Status of Quality of Life Diagnostics in Caring for Breast Cancer Patients: Results From a Multilevel Implementation Study in a Regional Tumor Centre

Resource links provided by NLM:

Further study details as provided by Tumorzentrum Regensburg e.V.:

Estimated Enrollment: 190
Study Start Date: December 2002
Estimated Study Completion Date: June 2004
Detailed Description:

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 older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00141635

Tumorzentrum Regensburg
Regensburg, Bavaria, Germany, 93053
Sponsors and Collaborators
Tumorzentrum Regensburg e.V.
Study Chair: Monika KS Klinkhammer-Schalke, MD Tumorzentrum Regensburg e.V.
Principal Investigator: Michael MK Koller, Ph.D. University of Marburg, Institut of Theoretical Surgery
Principal Investigator: Brigitte BE Ernst, MD General Practitioner, Bad Abbach
Principal Investigator: Ferdinand FH Hofstädter, MD, Prof. Tumorzentrum Regensburg e.V.
Principal Investigator: Wilfried WL Lorenz, MD, Prof. Tumorzentrum Regensburg e.V.
  More Information

Additional Information:
Publications: Identifier: NCT00141635     History of Changes
Other Study ID Numbers: TUZ-QL-IP-03
Study First Received: August 31, 2005
Last Updated: August 31, 2005

Keywords provided by Tumorzentrum Regensburg e.V.:
Quality of Life
Breast Cancer
Referee's Report

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on September 20, 2017