Quality of Life in Patients With Multiple Myeloma
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00290095|
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : March 8, 2011
|Condition or disease|
|Multiple Myeloma Quality of Life|
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
- 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.
- When measuring changes in QoL in a pretest-posttest design,response shift can affect results. Patients with advanced disease can report surprisingly good QoL.Including response shift into quality of life research would allow a better understanding of changes in the QoL that patients report.
|Study Type :||Observational|
|Actual Enrollment :||260 participants|
|Official Title:||Quality of Life in Patients With Multiple Myeloma|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00290095
|Ullevaal University Hospital|
|Oslo, Norway, 0407|
|Principal Investigator:||Finn Wisløff, MD, PhD||Ullevål University Hospital, Norway|