Clinical trial · Observational
Factors Associated With Health-related Quality of Life and Social Participation of Patients 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematologic Neoplasm | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Individuals with Multiple Myeloma
- description
- 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.
- label
- Informal Caregivers of Individuals with Multiple Myeloma
- description
- 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.
Primary outcomes (6)
- measure
- Health related quality of life (HRQoL)
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDBates-Fraser LC, Mills J, Mihas P, Wildes TM, Kent EE, Erisnor G, Adams L, Grant SJ. "A lot to manage and still have some kind of a life": How multiple myeloma impacts the function and quality-of-life of Black-White patient-caregiver dyads. J Am Geriatr Soc. 2023 Oct;71(10):3208-3220. doi: 10.1111/jgs.18482. Epub 2023 Jun 16. PMID 37326501
- BACKGROUNDFederici S, Meloni F, Mancini A, Lauriola M, Olivetti Belardinelli M. World Health Organisation Disability Assessment Schedule II: contribution to the Italian validation. Disabil Rehabil. 2009;31(7):553-64. doi: 10.1080/09638280802240498. PMID 19191060
- BACKGROUNDEfficace F, Gaidano G, Petrucci MT, Niscola P, Cottone F, Codeluppi K, Antonioli E, Tafuri A, Larocca A, Potenza L, Fozza C, Pastore D, Rigolin GM, Offidani M, Romano A, Kyriakou C, Cascavilla N, Gozzetti A, Derudas D, Vignetti M, Cavo M. Association of IMWG frailty score with health-related quality of life profile of patients with relapsed refractory multiple myeloma in Italy and the UK: a GIMEMA, multicentre, cross-sectional study. Lancet Healthy Longev. 2022 Sep;3(9):e628-e635. doi: 10.1016/S2666-7568(22)00172-6. PMID 36102777
- BACKGROUNDLeBlanc MR, Bryant AL, LeBlanc TW, Yang Q, Sellars E, Chase CC, Smith SK. A cross-sectional observational study of health-related quality of life in adults with multiple myeloma. Support Care Cancer. 2022 Jun;30(6):5239-5248. doi: 10.1007/s00520-022-06943-5. Epub 2022 Mar 9. PMID 35262791
- BACKGROUNDLevasseur M, Lussier-Therrien M, Biron ML, Raymond E, Castonguay J, Naud D, Fortier M, Sevigny A, Houde S, Tremblay L. Scoping study of definitions of social participation: update and co-construction of an interdisciplinary consensual definition. Age Ageing. 2022 Feb 2;51(2):afab215. doi: 10.1093/ageing/afab215. PMID 35134843
- BACKGROUNDPritlove C, Jassi M, Burns B, McCurdy A. The work of managing multiple myeloma and its implications for treatment-related decision making: a qualitative study of patient and caregiver experiences. BMC Cancer. 2021 Jul 8;21(1):793. doi: 10.1186/s12885-021-08527-8.