- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00141635
Implementation of Quality of Life Diagnostics and Therapy
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
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding
Kontakter og lokationer
Studiesteder
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Bavaria
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Regensburg, Bavaria, Tyskland, 93053
- Tumorzentrum Regensburg
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Monika KS Klinkhammer-Schalke, MD, Tumor Center Regensburg
- Ledende efterforsker: Michael MK Koller, Ph.D., University of Marburg, Institut of Theoretical Surgery
- Ledende efterforsker: Brigitte BE Ernst, MD, General Practitioner, Bad Abbach
- Ledende efterforsker: Ferdinand FH Hofstädter, MD, Prof., Tumor Center Regensburg
- Ledende efterforsker: Wilfried WL Lorenz, MD, Prof., Tumor Center Regensburg
Publikationer og nyttige links
Generelle publikationer
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Studieafslutning
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- TUZ-QL-IP-03
- 3.5/8203-1/117/02
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