Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00290095
Status:
COMPLETED
Last Update Posted:
2011-03-08
First Post:
2006-02-09
Brief Title:
Quality of Life in Patients With Multiple Myeloma
Sponsor:
Ullevaal University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Quality of Life in Patients With Multiple Myeloma
Status:
COMPLETED
Status Verified Date:
2011-03
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:
The purpose of this study is to determine Clinically important difference and Response shift in quality of life in patients with Multiple Myeloma
Detailed Description:
Multiple myeloma is a plasma cell tumor with an annual incidence of 6 pr 100 000 In the absence of curative treatment the aim of the therapy is not only to induce an objective response and a prolongation of survival but also to improve the patients quality of life
This project will raise two problems which make QoL-data hard to interpret
1 In a clinical trial where many patients are included statistically significant differences are obtained However there is widespread agreement that p-values do not indicate whether a particular finding has clinical significance because statistical significance does not necessarily equate to a meaningful difference or change in QoL A crucial task for clinicians in interpreting trial-based QoL results is to determine if the observed change is clinically important to the patient
2 When measuring changes in QoL in a pretest-posttest designresponse shift can affect results Patients with advanced disease can report surprisingly good QoLIncluding response shift into quality of life research would allow a better understanding of changes in the QoL that patients report
This project will raise two problems which make QoL-data hard to interpret
1 In a clinical trial where many patients are included statistically significant differences are obtained However there is widespread agreement that p-values do not indicate whether a particular finding has clinical significance because statistical significance does not necessarily equate to a meaningful difference or change in QoL A crucial task for clinicians in interpreting trial-based QoL results is to determine if the observed change is clinically important to the patient
2 When measuring changes in QoL in a pretest-posttest designresponse shift can affect results Patients with advanced disease can report surprisingly good QoLIncluding response shift into quality of life research would allow a better understanding of changes in the QoL that patients report
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