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Quality of Life in Patients With Multiple Myeloma - NCT00290095-Oslo - 000(Clinical Trial 137579)



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City:  Oslo
Country:  
Norway
Conditions: Multiple Myeloma - Quality of Life
Purpose: The purpose of this study is to determine Clinically important difference and Response shift in quality of life in patients with Multiple Myeloma.
Study summary: 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 clinicans 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 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.
Criteria: Inclusion Criteria: - Multiple Myeloma - Age > 18 years - Informed consent Exclusion Criteria: - Terminal illness with life expectancy less than 3 months - Unable to fill in a questionnaire in norwegian
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Data Source: ClinicalTrials.gov
Date Processed: February 17, 2011
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