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Implementation of Quality of Life Diagnostics and Therapy

NCT ID: NCT00141635

Last Updated: 2005-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-12-31

Study Completion Date

2004-06-30

Brief Summary

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Implementation and Evaluation of Implementation of Quality of Life Diagnostics and Therapy in Individual Patients with Breast Cancer. A prospective study including 170 patients, 5 clinics and 38 general practitioners as coordinating doctors for quality of life therapies. Correlational study including several comparisons such as patients and their doctors.

Detailed Description

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Improving cancer patients' quality of life (QL) requires that QL-diagnostics, the availability of QL-enhancing treatment options and treatment decisions are being integrated into a clinical path. This description presents the development and implementation of such a clinical path in the Tumorcenter Regensburg.

The acting persons and institutions in this clinical path are the breast cancer patients, the hospitals, the family doctors or gynaecologists, and a QL-study team. Starting point is the QL-assessment either in the hospital or in doctors' practice (EORTC QLQ-C30 plus BR-23). The caring physician documents the patients' health status. Based on these two pieces of information, the QL-study team writes up a medical/QL-opinion plus therapy recommendation. This report is sent to the caring physician. The effectiveness of the therapy recommendation is assessed in the following QL-assessment. This clinical path is implemented via three interrelated methods of implementation: local opinion leaders, outreach visits, and quality circle.

A total of 38 physicians were made familiar with QL-diagnostics through outreach visits, and 12 opinion leaders were identified and convinced to support this project. The quality circle provided regular CME meetings on QL-enhancing therapy options (pain control, psychotherapy, physiotherapy, nutrition, social rehabilitation). A total of 170 QL-reports were sent to physicians. All 38 doctors found the QL-profiles comprehensible and the therapy recommendations clinically relevant. The most common QL-problems were emotional functioning, fatigue, and arm/shoulder problems.

QL-diagnostics is a new way to individualise and to rationalise patient care. It transforms the QL-concept into a decision-relevant, integral part of a clinical path that aims to provide high quality patient care.

Conditions

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Breast Neoplasms

Keywords

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Quality of Life Breast Cancer Referee's Report Diagnostics Therapy

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Interventions

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physio,pain,psychotherapy;social,nutrit.counselling&sports

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* All patients with primary breast cancer in the county of Regensburg, Amberg and Sulzbach-Rosenberg in the year 2003 to June 2004 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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tumor Center Regensburg

OTHER

Sponsor Role lead

Principal Investigators

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Monika KS Klinkhammer-Schalke, MD

Role: STUDY_CHAIR

Tumor Center Regensburg

Michael MK Koller, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Marburg, Institut of Theoretical Surgery

Brigitte BE Ernst, MD

Role: PRINCIPAL_INVESTIGATOR

General Practitioner, Bad Abbach

Ferdinand FH Hofstädter, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Tumor Center Regensburg

Wilfried WL Lorenz, MD, Prof.

Role: PRINCIPAL_INVESTIGATOR

Tumor Center Regensburg

Locations

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Tumorzentrum Regensburg

Regensburg, Bavaria, Germany

Site Status

Countries

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Germany

References

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Koller M, Lorenz W. Quality of life: a deconstruction for clinicians. J R Soc Med. 2002 Oct;95(10):481-8. doi: 10.1177/014107680209501002. No abstract available.

Reference Type BACKGROUND
PMID: 12356967 (View on PubMed)

Related Links

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http://www.tumorzentrum-regensburg.de

Related Info

Other Identifiers

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3.5/8203-1/117/02

Identifier Type: -

Identifier Source: secondary_id

TUZ-QL-IP-03

Identifier Type: -

Identifier Source: org_study_id