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
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
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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
amount of QL-deficits at several intervals and at the end of the study period (1 year postoperatively)
operation till 1 year after operation
Monika KS Klinkhammer-Schalke, MD
Tumorzentrum Regensburg e.V.
Germany: Ethics Commission