NCT00141635

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2002

Geographic Reach
1 country

1 active site

Status
completed

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

December 1, 2002

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2005

Completed
Last Updated

September 1, 2005

Status Verified

August 1, 2005

First QC Date

August 31, 2005

Last Update Submit

August 31, 2005

Conditions

Breast Neoplasms

Keywords

Quality of LifeBreast CancerReferee's ReportDiagnosticsTherapy

Interventions

physio,pain,psychotherapy;social,nutrit.counselling&sportsBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

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

Location

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

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Monika KS Klinkhammer-Schalke, MD

    Tumor Center Regensburg

    STUDY CHAIR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 31, 2005

First Posted

September 1, 2005

Study Start

December 1, 2002

Study Completion

June 1, 2004

Last Updated

September 1, 2005

Record last verified: 2005-08

Locations

DE(1)