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Sponsored by: |
Tumorzentrum Regensburg e.V. |
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Information provided by: | Tumorzentrum Regensburg e.V. |
ClinicalTrials.gov Identifier: | NCT00145743 |
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.
Condition | Intervention | Phase |
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Breast Neoplasms |
Behavioral: physio,pain,psychotherapy;social,nutrit.counselling&sports |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Enrollment: | 200 |
Study Start Date: | November 2004 |
Study Completion Date: | October 2007 |
Arms | Assigned Interventions |
---|---|
1: Experimental
Patient's reported questionaire, profile in 10 dimensions (EORTC) and referees' report with treatment recommendations
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Behavioral: physio,pain,psychotherapy;social,nutrit.counselling&sports
profile and treatment recommendations based on the profile vs. routine psychooncology
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2: Experimental
Patient's reported questionaire; no recommendations given
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Behavioral: physio,pain,psychotherapy;social,nutrit.counselling&sports
profile and treatment recommendations based on the profile vs. routine psychooncology
|
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany, Bavaria | |
Tumorzentrum Regensburg | |
Regensburg, Bavaria, Germany, 93053 |
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. |
Study ID Numbers: | TUZ-QL-RS-04, 3.5/8203-1/117/02 |
Study First Received: | September 1, 2005 |
Last Updated: | November 26, 2007 |
ClinicalTrials.gov Identifier: | NCT00145743 |
Health Authority: | Germany: Ethics Commission |
Quality of Life Breast Cancer Referee's Report Diagnostics Therapy |
Skin Diseases Quality of Life Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |