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|