What affects quality of life and everyday participation for people with multiple myeloma and their caregivers
Official title: Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers: a Mixed Methods Study
Run by Azienda USL Reggio Emilia - IRCCS · NCT07014865 · Data updated 2026-11-12
This project will try to identify factors that affect quality of life and everyday participation for adults with multiple myeloma and their primary informal caregivers.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 190 (estimated) |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Locations | 1 site (Reggio Emilia, RE) |
| Status | Recruiting |
| Started | June 17, 2025 |
| Main results expected | June 2026 |
| Study ends | January 2027 |
| Registry record updated | August 29, 2025 |
| Trial ID | NCT07014865 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults (≥18) with a diagnosis of multiple myeloma receiving treatment (first-line, second-line, or later) at the Hematology Unit in Reggio Emilia who speak Italian, along with their primary informal caregivers.
✕Probably not a fit
Patients with severe cognitive impairment or psychiatric disorders that limit participation, non-Italian speakers, or those not treated at the Reggio Emilia center are unlikely to receive benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a concurrent exploratory mixed-methods project combining quantitative and qualitative approaches. The quantitative phase will describe relationships between identified factors and patients' health-related quality of life (HRQoL) and participation, and between those factors and caregivers' reactions and self-efficacy. The qualitative phase will explore how and why multiple myeloma impacts daily life for patients and their primary informal caregivers through in-depth interviews. Final analyses will compare and integrate quantitative and qualitative results to produce a comprehensive local picture to inform rehabilitation and support needs.
Why it matters
Potential benefit: If successful, the results could identify specific rehabilitation and support targets to improve patients' HRQoL and everyday participation and to better support their caregivers.
How similar studies have gone: Previous work has measured patient-reported outcomes in multiple myeloma—mainly in randomized trials and some observational and qualitative studies—but combining local quantitative and qualitative data specifically to guide rehabilitation planning is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Azienda Unità Sanitaria Locale Reggio Emilia - IRCCS
Reggio Emilia, Re, Italy Recruiting
Study contacts
- Study coordinator: Sara Paltrinieri, PhD, OT
- Email: sara.paltrinieri@ausl.re.it
- Phone: 0039 0522 522416
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.