The Burden of Multiple Myeloma on Patients and Caregivers Quality of Life: a Canadian Real-World Study

Completed

• Conditions: Multiple Myeloma; Caregiver Subjective Burden; Quality of Life (QOL)
• Interventions: Other: No intervention

• Registration Number: NCT06610045
• Lead Sponsor: PeriPharm

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 5,000 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 (https://periproxy.com/en), to sign the informed consent form and complete online questionnaires. Upon request, paper-based documents (i.e., informed consent form and questionnaires) can also be sent by mail. The following questionnaires will be used:

Patients

* Patient Information Questionnaire (i.e., baseline characteristics)

* EORTC QLQ-C30

* EORTC QLQ-MY20

* EQ-5D-5L

* ESAS-R

* Patients Perspective

Caregivers

* Caregiver Information Questionnaire (i.e., baseline characteristics)

* CarGOQoL

* Caregivers Perspective

If the sample size (i.e., 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 and/or 200 caregivers randomly selected. This scheme of participant identification will be performed until the sample size is reached.

Study Timeline

• Study First Submitted: 2024-09-12
• Study First Submitted QC: 2024-09-19
• Study First Posted: 2024-09-24
• Study Start: 2024-10-15
• Primary Completion: 2025-02-24
• Status Verified: 2025-03
• Study Completion: 2025-03-12
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

1. 18 years of age or older;

2. Part of the Myeloma Canada database;

   1. Identified as a patient with MM or
   2. Identified as a current caregiver of a patient with MM at the time of participation.

3. Ability to read and understand English or French;

4. Signature of informed consent form (ICF).

Exclusion Criteria

No exclusion criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with multiple myeloma	No intervention	Patients with multiple myeloma member of Myeloma Canada database
Caregivers of patients with myeloma	No intervention	Caregiver of a multiple myeloma patient member of Myeloma Canada database

Primary Outcome Measures

Name	Time	Method
To estimate quality of life of patients with myeloma and caregivers of patients with myeloma	From enrollment until sample size is reached

Secondary Outcome Measures

Name	Time	Method
To assess the correlation between QoL scores and perception of patients and caregivers respectively	From recruitment until sample size is reached

Trial Locations

Locations (1)

PROxy Network, an initiative of PeriPharm inc.; 🇨🇦 Montreal, Quebec, Canada