Clinical trial NCT00141635: Implementation of Quality of Life Diagnostics and Therapy
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: Quality of Life
Breast Cancer
Referee's Report
Diagnostics
Therapy
Lead sponsor: Tumor Center Regensburg
Sponsor class: OTHER
First posted: 2005-09-01
Enrollment: 190
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Tumorzentrum Regensburg
state: Bavaria
Study officials:
affiliation: Tumor Center Regensburg
name: Monika KS Klinkhammer-Schalke, MD
role: STUDY_CHAIR
affiliation: University of Marburg, Institut of Theoretical Surgery
name: Michael MK Koller, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: General Practitioner, Bad Abbach
name: Brigitte BE Ernst, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tumor Center Regensburg
name: Ferdinand FH Hofstädter, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Tumor Center Regensburg
name: Wilfried WL Lorenz, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koller M, Lorenz W. Quality of life: a deconstruction for clinicians. J R Soc Med. 2002 Oct;95(10):481-8. doi: 10.1177/014107680209501002. No abstract available.