A Phase 1/2 interventional study of physio,pain,psychotherapy;social,nutrit.counselling&sports in Breast Neoplasms, sponsored by Tumor Center Regensburg. Completed at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2007-11-27.
Sponsored by Tumor Center Regensburg · Phase 1/2, Interventional, and Treatment
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.
Quality of life (QL) is increasingly being accepted as an important endpoint in clinical studies, however little is known about its diagnostic value in order to optimize the therapy of cancer patients. This project at the Tumorcentre Regensburg aims to integrate QL-diagnostics into the therapy of patients with breast cancer and to evaluate the efficacy of QL-diagnostics in the context of a randomized clinical trial.
The Tumorcentre Regensburg provides the infrastructure of the present project (telemedicine, project groups, quality circle). Breast cancer patients' therapy is based on the recent national breast cancer therapy guideline, including assorted QL-enhancing therapy options, such as pain therapy, physiotherapy and lymphatic drainage, psychotherapy, social counseling and rehabilitation, nutrition and sports.
In the course of an implementation phase, a new method of QL diagnostics has been developed. Five experts with varying professional background use the individual patient's QL profile and clinical and sociodemographic information in order to generate a QL-report including a therapy recommendation.
This is a two-arm randomized clinical trial with one test group (communication of the QL-finding to the coordinating physician) and a control group (no communication). Patients with newly diagnosed breast cancer who are treated in the study region by one of the coordinating doctors will be included in this randomized study. QL-assessments (EORTC QLQ-C30 plus BR23) will be taken at designated points in time over a 12 months time course. Finally, patients will provide an overall evaluation of the course and the effects of the therapy using an open-ended questionnaire.
We expect that patients in the test group will experience a lower number of QL-deficits at the end of the study period (Median 1 +/- 2) than patients of the control group (Median 2 +/- 2). The statistical confirmation of this expected effect requires a total sample size of N = 200 (n=100 vs. n=100, alpha = 5% [two-tailed], beta = 10%).
This is the first study to evaluate a new form of QL-diagnostics in the complexity of a real patient care environment. This study promises to reveal important new insights into advanced patient care and will make the inclusion of the quality of life concept in the current breast cancer treatment guideline more concrete.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 200 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Tumor Center Regensburg is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient's reported questionaire, profile in 10 dimensions (EORTC) and referees' report with treatment recommendations
Behavioral: physio,pain,psychotherapy;social,nutrit.counselling&sports
Patient's reported questionaire; no recommendations given
Behavioral: physio,pain,psychotherapy;social,nutrit.counselling&sports
profile and treatment recommendations based on the profile vs. routine psychooncology
amount of QL-deficits at several intervals and at the end of the study period (1 year postoperatively)
Time frame: operation till 1 year after operation
This study is completed, as verified in Nov 2007. You cannot join it, but the record below documents what was studied.
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Tumor Center Regensburg