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Quality of Life in Patients With Multiple Myeloma
This study is currently recruiting participants.
Verified by Ullevaal University Hospital, February 2006
First Received: February 9, 2006   Last Updated: October 16, 2006   History of Changes
Sponsor: Ullevaal University Hospital
Information provided by: Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00290095
  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: Longitudinal, Defined Population, Prospective Study
Official Title: Quality of Life in Patients With Multiple Myeloma

Resource links provided by NLM:


Further study details as provided by Ullevaal University Hospital:

Estimated Enrollment: 210
Study Start Date: January 2006
Estimated Study Completion Date: January 2008
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 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Contacts
Contact: Ann Kristin Kvam, MD +47 41 92 72 52 annkristin.kvam@ulleval.no
Contact: Finn Wisløff, MD, PhD +47 22 11 92 45 f.g.b.wisloff@medisin.uio.no

Locations
Norway
Ullevaal University Hospital Recruiting
Oslo, Norway, 0407
Contact: Ann Kristin Kvam, MD     +47 41 92 72 52     annkristin.kvam@ulleval.no    
Contact: Finn Wisløff, MD, PhD     +47 22 11 92 45     f.g.b.wisloff@medisin.uio.no    
Principal Investigator: Finn Wisløff, MD, PhD            
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Principal Investigator: Finn Wisløff, MD, PhD Ullevål University Hospital, Norway
  More Information

No publications provided

Study ID Numbers: 1.2005.1269
Study First Received: February 9, 2006
Last Updated: October 16, 2006
ClinicalTrials.gov Identifier: NCT00290095     History of Changes
Health Authority: Norway: The National Committees for Research Ethics in Norway

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

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

ClinicalTrials.gov processed this record on February 08, 2010