Implementation of Quality of Life Diagnostics and Therapy

Breast Neoplasms Clinical Trial

Official title:

Enhancing the Status of Quality of Life Diagnostics in Caring for Breast Cancer Patients: Results From a Multilevel Implementation Study in a Regional Tumor Centre

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141635
• Other study ID #: TUZ-QL-IP-03
• Secondary ID: 3.5/8203-1/117/0
• Status: Completed
• Phase: Phase 1
• First received: August 31, 2005
• Last updated: August 31, 2005
• Start date: December 2002
• Est. completion date: June 2004

Study information

• Verified date: August 2005
• Source: Tumorzentrum Regensburg e.V.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Behavioral:
• physio,pain,psychotherapy;social,nutrit.counselling&sports

Locations

Country	Name	City	State
Germany	Tumorzentrum Regensburg	Regensburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Tumorzentrum Regensburg e.V.

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Koller M, Lorenz W. Quality of life: a deconstruction for clinicians. J R Soc Med. 2002 Oct;95(10):481-8. Review. — View Citation

External Links

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