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Quality of Life in Patients With Multiple Myeloma

Quality of Life in Patients With Multiple Myeloma

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00290095
Enrollment
260
Registered
2006-02-10
Start date
2006-01-31
Completion date
2008-06-30
Last updated
2011-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Myeloma, Quality of Life

Keywords

Multiple Myeloma, Quality of Life, Response Shift, Clinically Important Difference

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.

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.

Interventions

None listed

Sponsors

Ullevaal University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026