Diagnostics and Therapy of Disease-Related Quality of Life of Patients With Breast Cancer
2 other identifiers
interventional
200
1 country
1
Brief Summary
Quality of Life-Diagnostics and -Therapy in Individual Patients with Breast Cancer. A randomized study including 200 patients, 5 clinics and 43 general practitioners as coordinating doctors for quality of life therapies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2004
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 1, 2005
CompletedFirst Posted
Study publicly available on registry
September 5, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedNovember 27, 2007
November 1, 2007
September 1, 2005
November 26, 2007
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
amount of QL-deficits at several intervals and at the end of the study period (1 year postoperatively)
operation till 1 year after operation
Study Arms (2)
1
EXPERIMENTALPatient's reported questionaire, profile in 10 dimensions (EORTC) and referees' report with treatment recommendations
2
EXPERIMENTALPatient's reported questionaire; no recommendations given
Interventions
profile and treatment recommendations based on the profile vs. routine psychooncology
Eligibility Criteria
You may qualify if:
- All patients with primary breast cancer in the county of Regensburg, Amberg and Sulzbach-Rosenberg from November 2004 to approximately June 2006 submitted by coordinating physicians who were trained in quality of life questionnaires and profiles
You may not qualify if:
- Secondary breast cancer, patients who refused to participate, patients incapable of filling out questionnaires, male patients, pregnant patients, age below 18 yrs.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tumorzentrum Regensburg
Regensburg, Bavaria, 93053, Germany
Related Publications (1)
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.
PMID: 12356967BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Monika KS Klinkhammer-Schalke, MD
Tumor Center Regensburg
- 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.
Tumor Center Regensburg
- PRINCIPAL INVESTIGATOR
Wilfried WL Lorenz, MD, Prof.
Tumor Center Regensburg
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 1, 2005
First Posted
September 5, 2005
Study Start
November 1, 2004
Study Completion
October 1, 2007
Last Updated
November 27, 2007
Record last verified: 2007-11