- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning
Kontakter och platser
Studieorter
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Bavaria
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Regensburg, Bavaria, Tyskland, 93053
- Tumorzentrum Regensburg
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Monika KS Klinkhammer-Schalke, MD, Tumor Center Regensburg
- Huvudutredare: Michael MK Koller, Ph.D., University of Marburg, Institut of Theoretical Surgery
- Huvudutredare: Brigitte BE Ernst, MD, General Practitioner, Bad Abbach
- Huvudutredare: Ferdinand FH Hofstädter, MD, Prof., Tumor Center Regensburg
- Huvudutredare: Wilfried WL Lorenz, MD, Prof., Tumor Center Regensburg
Publikationer och användbara länkar
Allmänna publikationer
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Avslutad studie
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- TUZ-QL-IP-03
- 3.5/8203-1/117/02
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