Viewing Study NCT00141635


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Study NCT ID: NCT00141635
Status: COMPLETED
Last Update Posted: 2005-09-01
First Post: 2005-08-31
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Implementation of Quality of Life Diagnostics and Therapy
Sponsor: Tumor Center Regensburg
Organization:

Study Overview

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
Status: COMPLETED
Status Verified Date: 2005-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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.
Detailed 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.

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
3.5/8203-1/117/02 None None View