Quality of Life the Danish Multiple Myeloma Patients
QoL-MM
Quality of Life in Danish Multiple Myeloma Patients
1 other identifier
observational
681
1 country
10
Brief Summary
The aim of the project is to improve quality of life for multiple myeloma patients in the future.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2016
CompletedFirst Posted
Study publicly available on registry
September 8, 2016
CompletedStudy Start
First participant enrolled
February 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2023
CompletedSeptember 23, 2024
September 1, 2024
6.8 years
June 14, 2016
September 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
A longitudinal description of quality of life (QoL) using patient-reported outcomes measurement (PROM) for the general population of multiple myeloma patients.
a. Description of changes in QoL over time
24 months
Secondary Outcomes (3)
Description of changes in QoL over time, based on PROM for the general population of multiple myeloma patients.
24 months
Description of the impact of peripheral neuropathy on QoL in the general population of multiple myeloma patients over time, based on PROM.
24 months
Description of the impact of recalibration response shift for interpretation of data from longitudinal QoL studies using PROM for QoL measurement in the general population of previously untreated multiple myeloma patients.
9 months
Eligibility Criteria
Danish multiple myeloma patients
You may qualify if:
- Previously untreated or relapsed multiple myeloma patients AND
- Treatment demanding multiple myeloma disease
You may not qualify if:
- Inability to understand the Danish language or
- Psychic or mental illness that prevents the patient from answering the questions in the questionnaires.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Odense University Hospitallead
- Danish Myeloma Study Groupcollaborator
Study Sites (10)
Sygehus Sønderjylland
Aabenraa, Denmark
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet
Copenhagen, Denmark
Sydvestjysk Sygehus
Esbjerg, Denmark
Herlev Hospital
Herlev, Denmark
Hospitalsenheden Vest
Holstebro, Denmark
Odense University Hospital
Odense, Denmark
Sjællands Universitetshospital
Roskilde, Denmark
Vejle Sygehus
Vejle, Denmark
Related Publications (1)
Engelhardt M, Ihorst G, Singh M, Rieth A, Saba G, Pellan M, Lebioda A. Real-World Evaluation of Health-Related Quality of Life in Patients With Multiple Myeloma From Germany. Clin Lymphoma Myeloma Leuk. 2021 Feb;21(2):e160-e175. doi: 10.1016/j.clml.2020.10.002. Epub 2020 Oct 24.
PMID: 33218965DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lene Kongsgaard Nielsen, MD
Quality of Life Research Centre, Haematological Department, Odense Univsersity Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Specialist in Haematology
Study Record Dates
First Submitted
June 14, 2016
First Posted
September 8, 2016
Study Start
February 27, 2017
Primary Completion
November 30, 2023
Study Completion
November 30, 2023
Last Updated
September 23, 2024
Record last verified: 2024-09
Data Sharing
- IPD Sharing
- Will share
The cohort will be used as historical controls in clinical intervention trials