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

March 12, 2025 updated by: PeriPharm
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2Y 2H4
        • PROxy Network, an initiative of PeriPharm inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with myeloma and caregivers of patients with myeloma who are part of Myeloma Canada database

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with multiple myeloma
Patients with multiple myeloma member of Myeloma Canada database
Other: No intervention
No specific intervention is assess in this study.
Caregivers of patients with myeloma
Caregiver of a multiple myeloma patient member of Myeloma Canada database
Other: No intervention
No specific intervention is assess in this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To estimate quality of life of patients with myeloma and caregivers of patients with myeloma
Time Frame: From enrollment until sample size is reached
From enrollment until sample size is reached

Secondary Outcome Measures

Outcome Measure
Time Frame
To assess the correlation between QoL scores and perception of patients and caregivers respectively
Time Frame: From recruitment until sample size is reached
From recruitment until sample size is reached

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PeriPharm

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2024

Primary Completion (Actual)

February 24, 2025

Study Completion (Actual)

March 12, 2025

Study Registration Dates

First Submitted

September 12, 2024

First Submitted That Met QC Criteria

September 19, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROxy202301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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