Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06610045
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
The Burden of Multiple Myeloma on Patients and Caregivers Quality of Life a Canadian Real-World Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Burden of Multiple Myeloma on Patients and Caregivers Quality of Life a Canadian Real-World Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this observational study is to estimate the burden of multiple myeloma on patients and caregivers in terms of QoL Additionally this study will assess the correlation between QoL obtained from commonly used and validated questionnaires and the perceptions of both patients and caregivers respectively obtain from a 10-point scale and a comment box
Detailed Description:
Potential participants will be identified by Myeloma Canada using their database Myeloma Canada is a registered non-profit organization created by and for Canadians impacted by multiple myeloma As part of Myeloma Canada website patients and caregivers can subscribe to a mailing list to receive their monthly newsletter and to participate in surveys This database comprises about 5000 individuals including patients and caregivers
An e-mail will be sent to 600 patients and 200 caregivers randomly selected to invited them to participate in the survey Interested participants will be invited to visit the Participant Portal on the PROxy website httpsperiproxycomen to sign the informed consent form and complete online questionnaires Upon request paper-based documents ie informed consent form and questionnaires can also be sent by mail The following questionnaires will be used
Patients
Patient Information Questionnaire ie baseline characteristics
EORTC QLQ-C30
EORTC QLQ-MY20
EQ-5D-5L
ESAS-R
Patients Perspective
Caregivers
Caregiver Information Questionnaire ie baseline characteristics
CarGOQoL
Caregivers Perspective
If the sample size ie 300 patients and 100 caregivers is not reached one month after the first e-mail an invitation e-mail will be sent to an additional 600 eligible patients andor 200 caregivers randomly selected This scheme of participant identification will be performed until the sample size is reached
An e-mail will be sent to 600 patients and 200 caregivers randomly selected to invited them to participate in the survey Interested participants will be invited to visit the Participant Portal on the PROxy website httpsperiproxycomen to sign the informed consent form and complete online questionnaires Upon request paper-based documents ie informed consent form and questionnaires can also be sent by mail The following questionnaires will be used
Patients
Patient Information Questionnaire ie baseline characteristics
EORTC QLQ-C30
EORTC QLQ-MY20
EQ-5D-5L
ESAS-R
Patients Perspective
Caregivers
Caregiver Information Questionnaire ie baseline characteristics
CarGOQoL
Caregivers Perspective
If the sample size ie 300 patients and 100 caregivers is not reached one month after the first e-mail an invitation e-mail will be sent to an additional 600 eligible patients andor 200 caregivers randomly selected This scheme of participant identification will be performed until the sample size is reached
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None