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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

Phase 1/Phase 2
18 Years
Not Enrolling
Breast Neoplasms

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Trial Information

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
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.

Inclusion Criteria:

- All patients with primary breast cancer in the county of Regensburg, Amberg and
Sulzbach-Rosenberg from November 2004 to approximately June 2006 submitted by
coordinating physicians who were trained in quality of life questionnaires and

Exclusion Criteria:

- Secondary breast cancer, patients who refused to participate, patients incapable of
filling out questionnaires, male patients, pregnant patients, age below 18 yrs.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

amount of QL-deficits at several intervals and at the end of the study period (1 year postoperatively)

Outcome Time Frame:

operation till 1 year after operation

Principal Investigator

Monika KS Klinkhammer-Schalke, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Tumorzentrum Regensburg e.V.


Germany: Ethics Commission

Study ID:




Start Date:

November 2004

Completion Date:

October 2007

Related Keywords:

  • Breast Neoplasms
  • Quality of Life
  • Breast Cancer
  • Referee's Report
  • Diagnostics
  • Therapy
  • Breast Neoplasms
  • Neoplasms