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

This study has been completed.
Sponsor:
Information provided by:
Tumorzentrum Regensburg e.V.
ClinicalTrials.gov Identifier:
NCT00145743
First received: September 1, 2005
Last updated: November 26, 2007
Last verified: November 2007
  Purpose

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
Breast Neoplasms
Behavioral: physio,pain,psychotherapy;social,nutrit.counselling&sports
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Tumorzentrum Regensburg e.V.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: November 2004
Study Completion Date: October 2007
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00145743

Locations
Germany
Tumorzentrum Regensburg
Regensburg, Bavaria, Germany, 93053
Sponsors and Collaborators
Tumorzentrum Regensburg e.V.
Investigators
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.
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00145743     History of Changes
Other Study ID Numbers: TUZ-QL-RS-04, 3.5/8203-1/117/02
Study First Received: September 1, 2005
Last Updated: November 26, 2007
Health Authority: Germany: Ethics Commission

Keywords provided by Tumorzentrum Regensburg e.V.:
Quality of Life
Breast Cancer
Referee's Report
Diagnostics
Therapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014