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Quality of Life in Patients With Multiple Myeloma

Sponsor
Ullevaal University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00290095
Collaborator
(none)
260
Enrollment
1
Location
29
Duration (Months)
9
Patients Per Site Per Month

Study Details

Study Description

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 Intervention/Treatment Phase

    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 Design

    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 :
    Jan 1, 2006
    Actual Primary Completion Date :
    Jun 1, 2008
    Actual Study Completion Date :
    Jun 1, 2008

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Ullevaal University Hospital Oslo Norway 0407

      Sponsors and Collaborators

      • Ullevaal University Hospital

      Investigators

      • Principal Investigator: Finn Wisløff, MD, PhD, Ullevål University Hospital, Norway

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00290095
      Other Study ID Numbers:
      • 1.2005.1269
      First Posted:
      Feb 10, 2006
      Last Update Posted:
      Mar 8, 2011
      Last Verified:
      Mar 1, 2011
      Keywords provided by , ,
      Multiple Myeloma
      Quality of Life
      Response Shift
      Clinically Important Difference
      Additional relevant MeSH terms:
      Multiple Myeloma
      Neoplasms, Plasma Cell

      Study Results

      No Results Posted as of Mar 8, 2011