Quality of Life in Patients With Multiple Myeloma
The purpose of this study is to determine Clinically important difference and Response shift in quality of life in patients with Multiple Myeloma.
Quality of Life
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Quality of Life in Patients With Multiple Myeloma|
|Study Start Date:||January 2006|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290095
|Ullevaal University Hospital|
|Oslo, Norway, 0407|
|Principal Investigator:||Finn Wisløff, MD, PhD||Ullevål University Hospital, Norway|