What affects quality of life and everyday participation for people with multiple myeloma and their caregivers
Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers: a Mixed Methods Study
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 |
|---|---|
| Enrollment | 190 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Locations | 1 site (Reggio Emilia, RE) |
| Trial ID | NCT07014865 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Reggio Emilia, RE
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.