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OpenTrials
Completed

NCT Number: NCT00290095

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Feb 10, 2006
Registry last updated
Mar 8, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.