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Quality of Life

Patient's reported questionaire, profile in 10 dimensions (EORTC) and referees' report with treatment recommendations

Patient's reported questionaire; no recommendations given

profile and treatment recommendations based on the profile vs. routine psychooncology

physio,pain,psychotherapy;social,nutrit.counselling&sports

Monika KS Klinkhammer-Schalke, MD

Michael MK Koller, Ph.D.

Brigitte BE Ernst, MD

Ferdinand FH Hofstädter, MD, Prof.

Wilfried WL Lorenz, MD, Prof.

Quality of Life-Diagnostics and -Therapy in Individual Patients with Breast Cancer.

A randomized study including 200 patients, 5 clinics and 43 general practitioners as coordinating doctors for quality of life therapies.

Quality of life (QL) is increasingly being accepted as an important endpoint in clinical studies, however little is known about its diagnostic value in order to optimize the therapy of cancer patients. This project at the Tumorcentre Regensburg aims to integrate QL-diagnostics into the therapy of patients with breast cancer and to evaluate the efficacy of QL-diagnostics in the context of a randomized clinical trial.

The Tumorcentre Regensburg provides the infrastructure of the present project (telemedicine, project groups, quality circle). Breast cancer patients' therapy is based on the recent national breast cancer therapy guideline, including assorted QL-enhancing therapy options, such as pain therapy, physiotherapy and lymphatic drainage, psychotherapy, social counseling and rehabilitation, nutrition and sports.

In the course of an implementation phase, a new method of QL diagnostics has been developed. Five experts with varying professional background use the individual patient's QL profile and clinical and sociodemographic information in order to generate a QL-report including a therapy recommendation.

This is a two-arm randomized clinical trial with one test group (communication of the QL-finding to the coordinating physician) and a control group (no communication). Patients with newly diagnosed breast cancer who are treated in the study region by one of the coordinating doctors will be included in this randomized study. QL-assessments (EORTC QLQ-C30 plus BR23) will be taken at designated points in time over a 12 months time course. Finally, patients will provide an overall evaluation of the course and the effects of the therapy using an open-ended questionnaire.

We expect that patients in the test group will experience a lower number of QL-deficits at the end of the study period (Median 1 +/- 2) than patients of the control group (Median 2 +/- 2). The statistical confirmation of this expected effect requires a total sample size of N = 200 (n=100 vs. n=100, alpha = 5% \[two-tailed\], beta = 10%).

This is the first study to evaluate a new form of QL-diagnostics in the complexity of a real patient care environment. This study promises to reveal important new insights into advanced patient care and will make the inclusion of the quality of life concept in the current breast cancer treatment guideline more concrete.

Diagnostics and Therapy of Disease-Related Quality of Life of Patients With Breast Cancer

Diagnostics and Therapy of Disease-Related Quality of Life of Patients With Breast Cancer: Protocol of a Randomized Clinical Trial at the Tumor Center Regensburg

Tumor Center Regensburg

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.

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.

Implementation of Quality of Life Diagnostics and Therapy

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 title	NCT ID	Conditions	Interventions	Eligibility	Organization
Diagnostics and Therapy of Disease-Related Quality of Life of Patients With Breast Cancer	NCT00145743	Breast Neoplasm...	physio,pain,psy...	18 Years -	Tumor Center Regensburg
Implementation of Quality of Life Diagnostics and Therapy	NCT00141635	Breast Neoplasm...	physio,pain,psy...	18 Years -	Tumor Center Regensburg
Diagnostics and Therapy of Disease-Related Quality of Life of Patients With Breast Cancer	NCT00145743	Breast Neoplasm...	physio,pain,psy...	18 Years -	Tumor Center Regensburg

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