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

NCT ID: NCT06610045

Last Updated: 2025-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-15

Study Completion Date

2025-03-12

Brief Summary

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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

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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.

Conditions

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Multiple Myeloma Caregiver Subjective Burden Quality of Life (QOL)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients with multiple myeloma

Patients with multiple myeloma member of Myeloma Canada database

No intervention

Intervention Type OTHER

No specific intervention is assess in this study.

Caregivers of patients with myeloma

Caregiver of a multiple myeloma patient member of Myeloma Canada database

No intervention

Intervention Type OTHER

No specific intervention is assess in this study.

Interventions

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No intervention

No specific intervention is assess in this study.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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PeriPharm

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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PROxy Network, an initiative of PeriPharm inc.

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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PROxy202301

Identifier Type: -

Identifier Source: org_study_id

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