Quality of Life in Patients With Multiple Myeloma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00290095
Recruitment Status : Completed
First Posted : February 10, 2006
Last Update Posted : March 8, 2011
Information provided by:
Oslo 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.

Condition or disease
Multiple Myeloma Quality of Life

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.

Study Type : Observational
Actual Enrollment : 260 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quality of Life in Patients With Multiple Myeloma
Study Start Date : January 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Multiple Myeloma in all fases in the south and east of Norway

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00290095

Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Principal Investigator: Finn Wisløff, MD, PhD Ullevål University Hospital, Norway

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00290095     History of Changes
Other Study ID Numbers: 1.2005.1269
First Posted: February 10, 2006    Key Record Dates
Last Update Posted: March 8, 2011
Last Verified: March 2011

Keywords provided by Oslo University Hospital:
Multiple Myeloma
Quality of Life
Response Shift
Clinically Important Difference

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases