Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers

NCT07014865 | Recruiting

• 1 other identifier: 121/2025/OSS/AUSLRE
• Study Type: observational
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma (MM); Hematologic Neoplasm

Keywords

Quality of Life; Social Participation; Caregivers; Observational study; Qualitative Research

Outcome Measures

Primary Outcomes (6)

• Health related quality of life (HRQoL)

  HRQoL in individuals with MM measured by the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (Quality of Life Questionnaire - Core 30). The QLQ-C30 is composed of three subscales: global health status (two items), functional scales (15 items), symptom scale/ individual items (13 items). Each item is assigned a score between 1 and 4 (4-point Likert scale), excluding items n. 29 and n. 30 (7-point Likert scale). All the subscales and single-item measures range in score from 0 to 100. The higher the score for the global health status, the better the quality of life. The higher the score for the functional scale, the higher the level of functioning. Instead, the higher the score for symptom scale/items, the worse the symptoms.

  24 months

• Health related quality of life (HRQoL)

  HRQoL in individuals with MM measured by the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Multiple Myeloma Module (EORTC) QLQ-MY20. The QLQ-MY20 consists of two subscales on disease symptoms (6 items) and side-effect of treatment (10 items), one functional scale on future perspective (3 items), and one single item on body image. All the subscales and single-item measures of the QLQ-MY20 range in score from 0 to 100. A higher score for disease symptoms and side-effects of treatment indicated worse outcomes, while a higher score in the body image and future perspective indicated better outcomes.

  24 months

• Participation

  Participation in individuals with MM measured by the World Health Organization Disability Assessment Schedule (WHODAS 2.0). WHODAS 2.0 captures the level of functioning in six domains of life: cognition (6 items), mobility (5 items), self-care (4 items), getting along (5 items), life activities (8 items), participation (8 items). Each item of the WHODAS 2.0 is assigned a score between 1 and 5 (5-point Likert scale). The higher the score, the higher the level of disability.

  24 months

• Reactions to caring

  Reactions to caring in caregivers of individuals with MM measured by the Caregiver Reaction Assessment scale (CRA). The CRA is composed of 24 items categorized in 5 subscales: impact on schedule (5 items), impact on finances (3 items), lack of family support (5 items), impact on health (4 items) and caregiver esteem (7 items). Each item is assigned a score between 1 and 5 (5-point Likert scale). The higher the score for the impact on schedule, impact on finances, lack of family support, and impact on health domains, the more the negative impact of caregiving activity, while a higher score in the caregiver esteem domain indicated more positive impact of caregiving activity.

  24 months

• 5. Self-efficacy

  Self-efficacy in caregivers of individuals with MM measured by the Caregiver Inventory (CGI-I). It is composed of 21 items categorized in four subscales: managing medical information (3 items), caring for the care recipient (7 items), caring for oneself (5 items), managing difficult interactions/emotions (6 items). Each item is assigned a score between 1 and 9 (9-point Likert scale). Higher scores indicate greater self-efficacy for caregiving.

  24 months

• Open-ended questions of a semi-structured interview that was written by researchers and clinicians and with the support of expert individuals with MM and their caregivers to collect the disease-related experiences and its consequences on daily life

  Themes describing the disease-related experiences and its consequences on daily life of individuals with MM and their caregivers generated through the listening of their narratives

  24 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult individuals diagnosed with MM who are receiving treatment at the Hematology Unit of the Azienda USL-IRCCS of Reggio Emilia, and their primary informal caregivers. This population reflects a real-world clinical context, including patients at different lines of therapy (LOT I, II, or ≥III) and with diverse sociodemographic and clinical backgrounds.

You may qualify if:

• diagnosis of MM
• adulthood (≥ 18 years)
• in treatment (LOT I, II, or ≥ III) at the Hematology Unit
• speak Italian fluently

You may not qualify if:

• Comorbidities that limit collaboration (e.g., dementia, severe psychiatric disorders).
• \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
• 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

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead

Study Sites (1)

Azienda Unità Sanitaria Locale Reggio Emilia - IRCCS

Reggio Emilia, RE, 42123, Italy

RECRUITING

Related Publications (6)

• Bates-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 BACKGROUND

• Federici 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 BACKGROUND

• Efficace 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 BACKGROUND

• LeBlanc 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 BACKGROUND

• Levasseur 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 BACKGROUND

• Pritlove 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.

  PMID: 34238260 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Neoplasms by Site

Central Study Contacts

Sara Paltrinieri, PhD, OT

CONTACT

0039 0522 522416; sara.paltrinieri@ausl.re.it

Stefania Costi, PhD, PT

CONTACT

0039 0522 522441; stefania.costi@unimore.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 11, 2025
• Study Start: June 17, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)