Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers: a Mixed Methods Study
Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• diagnosis of MM
• adulthood (≥ 18 years)
• in treatment (LOT I, II, or ≥ III) at the Hematology Unit
• speak Italian fluently
• having a loved one (individual with MM) who have participated in the quantitative phase
• being the primary informal caregiver
• adulthood (≥ 18 years)
• speak Italian fluently
Locations
Other Locations
Italy
Azienda Unità Sanitaria Locale Reggio Emilia - IRCCS
RECRUITING
Reggio Emilia
Contact Information
Primary
Sara Paltrinieri, PhD, OT
sara.paltrinieri@ausl.re.it
0039 0522 522416
Backup
Stefania Costi, PhD, PT
stefania.costi@unimore.it
0039 0522 522441
Time Frame
Start Date:2025-06-17
Estimated Completion Date:2027-01
Participants
Target number of participants:190
Treatments
Individuals with Multiple Myeloma
This cohort includes individuals diagnosed with multiple myeloma and receiving treatment at the Hematology Unit of the Azienda USL-IRCCS di Reggio Emilia. The cohort will reflect a real-world clinical population, including individuals across different treatment lines and sociodemographic backgrounds. Patients with severe cognitive or psychiatric comorbidities that prevent active participation (e.g., dementia, severe mental illness) will be excluded.
Informal Caregivers of Individuals with Multiple Myeloma
This cohort will include informal (unpaid) primary caregivers of individuals with multiple myeloma who are participating in the study. For each eligible patient, we will ask if there is a caregiver-identified by the patient-available and willing to participate. Informal caregivers may include family members, relatives, or close companions who provide regular, unpaid care and support. If no caregiver is available or willing to participate, the patient may still take part in the study; however, caregivers cannot be enrolled independently of the patient.