Diagnostics and Therapy of Disease-Related Quality of Life of Patients With Breast Cancer
Summary
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.
Description
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.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Conditions
Breast Neoplasms
Intervention
physio,pain,psychotherapy;social,nutrit.counselling&sports
Location
Tumorzentrum Regensburg
Regensburg
Bavaria
Germany
93053
Status
Completed
Source
Tumorzentrum Regensburg e.V.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00145743
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Shoulder Pain
Unilateral or bilateral pain of the shoulder. It is often caused by physical activities such as work or sports participation, but may also be pathologic in origin.
Breast Cyst
A fluid-filled closed cavity or sac that is lined by an EPITHELIUM and found in the BREAST. It may appear as a single large cyst in one breast, multifocal, or bilateral in FIBROCYSTIC BREAST DISEASE.
Doping In Sports
Illegitimate use of drugs for a desired effect in competitive sports; includes humans and animals.
Psychotherapy, Multiple
The use of more than one therapist at one time in individual or group psychotherapy.
Psychotherapy, Brief
Any form of psychotherapy designed to produce therapeutic change within a minimal amount of time, generally not more than 20 sessions.
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