Implementation of Quality of Life Diagnostics and Therapy

This study has been completed.
Sponsor:
Information provided by:
Tumorzentrum Regensburg e.V.
ClinicalTrials.gov Identifier:
NCT00141635
First received: August 31, 2005
Last updated: NA
Last verified: August 2005
History: No changes posted
  Purpose

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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00141635

Locations
Germany
Tumorzentrum Regensburg
Regensburg, Bavaria, Germany, 93053
Sponsors and Collaborators
Tumorzentrum Regensburg e.V.
Investigators
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:
ClinicalTrials.gov Identifier: NCT00141635     History of Changes
Other Study ID Numbers: TUZ-QL-IP-03, 3.5/8203-1/117/02
Study First Received: August 31, 2005
Last Updated: August 31, 2005
Health Authority: Germany: Ethics Commission

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014