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

November 26, 2007 updated by: Tumor Center Regensburg

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-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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • Tumorzentrum Regensburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 profiles

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Patient's reported questionaire, profile in 10 dimensions (EORTC) and referees' report with treatment recommendations
Behavioral: physio,pain,psychotherapy;social,nutrit.counselling&sports
profile and treatment recommendations based on the profile vs. routine psychooncology
Experimental: 2
Patient's reported questionaire; no recommendations given
Behavioral: physio,pain,psychotherapy;social,nutrit.counselling&sports
profile and treatment recommendations based on the profile vs. routine psychooncology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
amount of QL-deficits at several intervals and at the end of the study period (1 year postoperatively)
Time Frame: operation till 1 year after operation
operation till 1 year after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tumor Center Regensburg

Investigators

  • Study Chair: Monika KS Klinkhammer-Schalke, MD, Tumor Center Regensburg
  • 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., Tumor Center Regensburg
  • Principal Investigator: Wilfried WL Lorenz, MD, Prof., Tumor Center Regensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

September 1, 2005

First Submitted That Met QC Criteria

September 1, 2005

First Posted (Estimate)

September 5, 2005

Study Record Updates

Last Update Posted (Estimate)

November 27, 2007

Last Update Submitted That Met QC Criteria

November 26, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUZ-QL-RS-04
  • 3.5/8203-1/117/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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