Quality of Life in Patients With Multiple Myeloma
This study has been completed.
Sponsor:
Ullevaal University Hospital
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00290095
First received: February 9, 2006
Last updated: March 7, 2011
Last verified: March 2011
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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: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Quality of Life in Patients With Multiple Myeloma |
Resource links provided by NLM:
Further study details as provided by Oslo University Hospital:
| Enrollment: | 260 |
| Study Start Date: | January 2006 |
| Study Completion Date: | June 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Patients with Multiple Myeloma in all fases in the south and east of Norway
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 More Information
No publications provided by Oslo University Hospital
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00290095 History of Changes |
| Other Study ID Numbers: | 1.2005.1269 |
| Study First Received: | February 9, 2006 |
| Last Updated: | March 7, 2011 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Keywords provided by Oslo University Hospital:
|
Multiple Myeloma Quality of Life Response Shift Clinically Important Difference |
Additional relevant MeSH terms:
|
Multiple Myeloma Neoplasms, Plasma Cell Neoplasms by Histologic Type Neoplasms Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013