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Spots Global Cancer Trial Database for Implementation of Quality of Life Diagnostics and Therapy

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Trial Identification

Brief Title: Implementation of Quality of Life Diagnostics and Therapy

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

Study ID: NCT00141635

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: No

Locations

Tumorzentrum Regensburg, Regensburg, Bavaria, Germany

Contact Details

Name: Monika KS Klinkhammer-Schalke, MD

Affiliation: Tumor Center Regensburg

Role: STUDY_CHAIR

Name: Michael MK Koller, Ph.D.

Affiliation: University of Marburg, Institut of Theoretical Surgery

Role: PRINCIPAL_INVESTIGATOR

Name: Brigitte BE Ernst, MD

Affiliation: General Practitioner, Bad Abbach

Role: PRINCIPAL_INVESTIGATOR

Name: Ferdinand FH Hofstädter, MD, Prof.

Affiliation: Tumor Center Regensburg

Role: PRINCIPAL_INVESTIGATOR

Name: Wilfried WL Lorenz, MD, Prof.

Affiliation: Tumor Center Regensburg

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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