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Implementation of Quality of Life Diagnostics and Therapy

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ClinicalTrials.gov Identifier: NCT00141635
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : September 1, 2005
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Breast Neoplasms Behavioral: physio,pain,psychotherapy;social,nutrit.counselling&sports Phase 1

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.

Study Design

Study Type : Observational
Estimated Enrollment : 190 participants
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
Study Start Date : December 2002
Estimated Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00141635     History of Changes
Other Study ID Numbers: TUZ-QL-IP-03
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: September 1, 2005
Last Verified: August 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