Clinical trial NCT06610045: The Burden of Multiple Myeloma on Patients and Caregivers Quality of Life: a Canadian Real-World Study
Official title: The Burden of Multiple Myeloma on Patients and Caregivers Quality of Life: a Canadian Real-World Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Caregiver Subjective Burden
Quality of Life (QOL)
Keywords: quality of life
real-world
observational
myeloma
caregiver
Lead sponsor: PeriPharm
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with myeloma and caregivers of patients with myeloma who are part of Myeloma Canada database

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.

Eligibility criteria: 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

Primary outcomes:
measure: To estimate quality of life of patients with myeloma and caregivers of patients with myeloma
timeFrame: From enrollment until sample size is reached
Secondary outcomes:
measure: To assess the correlation between QoL scores and perception of patients and caregivers respectively
timeFrame: From recruitment until sample size is reached
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: PROxy Network, an initiative of PeriPharm inc.
state: Quebec
Study officials:
References: