Implementation of Quality of Life Diagnostics and Therapy
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Behavioral: physio,pain,psychotherapy;social,nutrit.counselling&sports |
Phase 1 |
| Study Type: | Observational |
| Study Design: | Additional Descriptors: Psychosocial Observational Model: Defined Population Time Perspective: Longitudinal Time Perspective: Prospective |
| 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 |
| Estimated Enrollment: | 190 |
| Study Start Date: | December 2002 |
| Estimated Study Completion Date: | June 2004 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Germany | |
| Tumorzentrum Regensburg | |
| Regensburg, Bavaria, Germany, 93053 | |
| Study Chair: | Monika KS Klinkhammer-Schalke, MD | Tumorzentrum Regensburg e.V. |
| Principal Investigator: | Michael MK Koller, Ph.D. | University of Marburg, Institut of Theoretical Surgery |
| Principal Investigator: | Brigitte BE Ernst, MD | General Practitioner, Bad Abbach |
| Principal Investigator: | Ferdinand FH Hofstädter, MD, Prof. | Tumorzentrum Regensburg e.V. |
| Principal Investigator: | Wilfried WL Lorenz, MD, Prof. | Tumorzentrum Regensburg e.V. |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00141635 History of Changes |
| Other Study ID Numbers: | TUZ-QL-IP-03, 3.5/8203-1/117/02 |
| Study First Received: | August 31, 2005 |
| Last Updated: | August 31, 2005 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Tumorzentrum Regensburg e.V.:
|
Quality of Life Breast Cancer Referee's Report Diagnostics Therapy |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 22, 2013