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.
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
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.
Cohort
Prospective
Not listed
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.
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.
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.
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.
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