Quality of Life in Patients With Multiple Myeloma
|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|
|Primary Completion Date :||June 2008|
|Study Completion Date :||June 2008|
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|