Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2025-12-26 @ 9:50 PM
Study NCT ID:
NCT00141635
Status:
COMPLETED
Last Update Posted:
2005-09-01
First Post:
2005-08-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of Quality of Life Diagnostics and Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-08', 'completionDateStruct': {'date': '2004-06'}, 'lastUpdateSubmitDate': '2005-08-31', 'studyFirstSubmitDate': '2005-08-31', 'studyFirstSubmitQcDate': '2005-08-31', 'lastUpdatePostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Quality of Life', 'Breast Cancer', "Referee's Report", 'Diagnostics', 'Therapy'], 'conditions': ['Breast Neoplasms']}, 'referencesModule': {'references': [{'pmid': '12356967', 'type': 'BACKGROUND', 'citation': 'Koller M, Lorenz W. Quality of life: a deconstruction for clinicians. J R Soc Med. 2002 Oct;95(10):481-8. doi: 10.1177/014107680209501002. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.tumorzentrum-regensburg.de', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nThe 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.\n\nA 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.\n\nQL-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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n\nExclusion Criteria:\n\n* Secondary breast cancer, patients who refused to participate, patients incapable of filling out questionnaires, male patients, pregnant patients, age below 18 yrs.'}, 'identificationModule': {'nctId': 'NCT00141635', 'briefTitle': 'Implementation of Quality of Life Diagnostics and Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Tumor Center Regensburg'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TUZ-QL-IP-03'}, 'secondaryIdInfos': [{'id': '3.5/8203-1/117/02'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'physio,pain,psychotherapy;social,nutrit.counselling&sports', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '93053', 'city': 'Regensburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Tumorzentrum Regensburg', 'geoPoint': {'lat': 49.01513, 'lon': 12.10161}}], 'overallOfficials': [{'name': 'Monika KS Klinkhammer-Schalke, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Tumor Center Regensburg'}, {'name': 'Michael MK Koller, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Marburg, Institut of Theoretical Surgery'}, {'name': 'Brigitte BE Ernst, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Practitioner, Bad Abbach'}, {'name': 'Ferdinand FH Hofstädter, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tumor Center Regensburg'}, {'name': 'Wilfried WL Lorenz, MD, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tumor Center Regensburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tumor Center Regensburg', 'class': 'OTHER'}}}}