Quality of Life in Patients With Multiple Myeloma

NCT ID: NCT00290095

Last Updated: 2011-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

260 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Study Completion Date

2008-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Multiple Myeloma Quality of Life

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ullevaal University Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Finn Wisløff, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ullevål University Hospital, Norway

Locations

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Ullevaal University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 20678240 (View on PubMed)

Other Identifiers

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1.2005.1269

Identifier Type: -

Identifier Source: org_study_id

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