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Recruiting NCT07014865

NCT07014865 Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers

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Clinical Trial Summary
NCT ID NCT07014865
Status Recruiting
Phase
Sponsor Azienda USL Reggio Emilia - IRCCS
Condition Multiple Myeloma (MM)
Study Type OBSERVATIONAL
Enrollment 190 participants
Start Date 2025-06-17
Primary Completion 2026-06

Trial Parameters

Condition Multiple Myeloma (MM)
Sponsor Azienda USL Reggio Emilia - IRCCS
Study Type OBSERVATIONAL
Phase N/A
Enrollment 190
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-06-17
Completion 2026-06

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Brief Summary

Individuals with multiple myeloma (MM) are vulnerable because of the effects of systemic organ damage and the side effects of treatment. A decline in patients' health-related quality of life (HRQoL) and a compromised participation in everyday life was reported. The diagnosis of MM negatively affects the principal informal caregiver. This is a concurrent exploratory mixed methods study that involves the use of a quantitative and a qualitative approach. For the quantitative study, aims are to describe any possible relation between the identified factors with HRQoL and participation in individuals with MM and with reactions to caring and self-efficacy of caregivers. For the qualitative study, aims are to investigate "how" and "why" the disease impacts the daily life of individuals with MM and their caregivers. The final analyses will be based on the comparison of the results of the quantitative phase and the results of the qualitative phase.

Eligibility Criteria

Inclusion criteria for individuals with MM will be: 1. diagnosis of MM 2. adulthood (≥ 18 years) 3. in treatment (LOT I, II, or ≥ III) at the Hematology Unit 4. speak Italian fluently Exclusion Criteria: Comorbidities that limit collaboration (e.g., dementia, severe psychiatric disorders). \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ Inclusion criteria for caregiver will be: 1. having a loved one (individual with MM) who have participated in the quantitative phase 2. being the primary informal caregiver 3. adulthood (≥ 18 years) 4. speak Italian fluently

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