Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145743
Status:
COMPLETED
Last Update Posted:
2007-11-27
First Post:
2005-09-01
Brief Title:
Diagnostics and Therapy of Disease-Related Quality of Life of Patients With Breast Cancer
Sponsor:
Tumor Center Regensburg
Organization:
Tumor Center Regensburg
Study Overview
Official Title:
Diagnostics and Therapy of Disease-Related Quality of Life of Patients With Breast Cancer Protocol of a Randomized Clinical Trial at the Tumor Center Regensburg
Status:
COMPLETED
Status Verified Date:
2007-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
A randomized study including 200 patients 5 clinics and 43 general practitioners as coordinating doctors for quality of life therapies
Detailed Description:
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 patients 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 n100 vs n100 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
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 patients 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 n100 vs n100 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 358203-111702 | None | None | None |