Quality of Life in Patients With Multiple Myeloma

This study has been completed.
Sponsor:
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00290095
First received: February 9, 2006
Last updated: March 7, 2011
Last verified: March 2011
  Purpose

The purpose of this study is to determine Clinically important difference and Response shift in quality of life in patients with Multiple Myeloma.


Condition
Multiple Myeloma
Quality of Life

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Quality of Life in Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Enrollment: 260
Study Start Date: January 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with Multiple Myeloma in all fases in the south and east of Norway

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00290095

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

No publications provided by Oslo University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00290095     History of Changes
Other Study ID Numbers: 1.2005.1269
Study First Received: February 9, 2006
Last Updated: March 7, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014