Clinical Trial on Quality of Life, Multiple Myeloma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

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

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.

Study Type

Observational

Enrollment (Actual)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Norway
- - Oslo, Norway, 0407
    - Ullevaal University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ullevaal University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Kvam AK, Wisloff F, Fayers PM. Minimal important differences and response shift in health-related quality of life; a longitudinal study in patients with multiple myeloma. Health Qual Life Outcomes. 2010 Aug 3;8:79. doi: 10.1186/1477-7525-8-79.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

June 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

February 9, 2006

First Submitted That Met QC Criteria