NCT07014865 Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers
| 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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 190 participants in total. It began in 2025-06-17 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07014865 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma (MM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07014865 currently recruiting?
Yes, NCT07014865 is actively recruiting participants. Contact the research team at sara.paltrinieri@ausl.re.it for enrollment information.
Where is the NCT07014865 trial being conducted?
This trial is being conducted at Reggio Emilia, Italy.
Who is sponsoring the NCT07014865 clinical trial?
NCT07014865 is sponsored by Azienda USL Reggio Emilia - IRCCS. The trial plans to enroll 190 participants.