Quality of Life in Patients With Multiple Myeloma
- Conditions
- Quality of LifeMultiple Myeloma
- Registration Number
- NCT00290095
- Lead Sponsor
- Ullevaal University Hospital
- Brief Summary
The purpose of this study is to determine Clinically important difference and Response shift in quality of life in patients with Multiple Myeloma.
- Detailed Description
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 clinicians 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 260
- Multiple Myeloma
- Age > 18 years
- Informed consent
- Terminal illness with life expectancy less than 3 months
- Unable to fill in a questionnaire in norwegian
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ullevaal University Hospital
🇳🇴Oslo, Norway