Multiple Myeloma (MM)MMYLIFENCT07014865
Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers
An observational study of Multiple Myeloma (MM) and Hematologic Neoplasm, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma (MM), Hematologic Neoplasm
- How many people
- 190 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jun 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Comorbidities that limit collaboration (e.g., dementia, severe psychiatric disorders).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Azienda Unità Sanitaria Locale Reggio Emilia - IRCCS
Reggio Emilia, RE, 42123
Sara Paltrinieri, PhD, OT, 00390522522416, sara.paltrinieri@ausl.re.it
Sara Paltrinieri, PhD, OT
About this study
Official title: Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers: a Mixed Methods Study
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.
Read the detailed description
MM is a hematological disease caused by an uncontrolled proliferation of plasma cells. Individuals with MM are vulnerable because of the effects of systemic organ damage and the side effects of treatment. A decline in patients' functional status, the deterioration of health-related quality of life (HRQoL) and a compromised participation in everyday life was reported. Moreover, the diagnosis of MM occurs within the context of a family and it negatively affects the principal informal caregiver.
According to the International Classification of Functioning, Disability and Health, participation in daily life plays a key role in rehabilitation as it confers a sense of normalcy to life. Comprehensive rehabilitation intervention aiming at improving HRQoL and facilitating participation has never been implemented with this aim.
From previous systematic reviews, it emerges that patient reported outcomes (PRO) of individuals with MM have been studied mainly in randomized clinical trials, but also few observational studies have been published, conducting also in Italy. In the province of Reggio Emilia, population-based data concerning the HRQoL of individuals with MM have never been collected, as well as for their caregivers. Needs related to participation in everyday life of individuals with MM and their caregivers were mainly studied through qualitative approach.
Although qualitative data are essential in describing a phenomenon, it is currently not possible to quantify the degree of loss of participation in everyday life or to identify patients most at risk of social isolation. As a counterpart, qualitative approach may explain those situations that quantitative approach cannot verify (e.g., reasons behind conditions of social vulnerability). For these reasons, it seems appropriate to explore the patients' perceived HRQoL and participation from both quantitative and qualitative perspectives, as well as the caregivers' burden, by integrating these data. In this study, needs and difficulties in accomplishing the relevant activities and roles as well as the description of factors that act as facilitators or barriers to HRQoL and participation will be identified to screen patients that might benefit most from rehabilitation. Based on these data, comprehensive and tailored rehabilitation may be planned in future studies and tested for its impact on HRQoL and participation.
This is a concurrent exploratory mixed methods study that involves the use of a quantitative and a qualitative approach. The quantitative is the main study, while the qualitative is the sub-study. Participants of the qualitative study will be a sub-group of those recruited in the quantitative study. In this mixed methods study, we will recruit individuals with MM and caregivers.
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. Data collection will be performed through an individual semi-structured interview conducted in person, remotely or through self-administration, based on participant preference and availability.
As for individuals with MM, the semi-structured interview will consist in the collection of sociodemographic and work-related characteristics, while the side effects of treatments, the needs perceived from this population and the outcomes of interest will be collected through validated assessment tools. Disease-related factors will be retrieved from medical records.
As for caregivers, the semi-structured interview will consist in the collection of sociodemographic and work-related characteristics, while the outcomes of interest will be collected through validated assessment tools. The analyses of the quantitative phase will be carried out at the end of the quantitative data collection.
Qualitative Sub-Study To complement the findings of the primary quantitative study, a qualitative sub-study will be conducted to deepen the understanding of the disease-related experiences of individuals with MM and their informal caregivers and its consequences on daily life.
This qualitative sub-study is embedded within the larger concurrent exploratory mixed methods design. Participants in the qualitative phase will be a purposeful sub-sample of those already enrolled in the quantitative study, selected to ensure variation in the line of therapy (LOT), gender, and occupational status. Inclusion will aim to represent diverse patient and caregiver experiences.
In this qualitative sub-study, open-ended questions will be asked to participants by using interview guides, one for individual with MM and one for caregiver. Before conducting the qualitative interviews, a preliminary phase will be organized where researchers will involve expert patients and caregivers to support them in defining themes and questions of the interview guide. As an example, questions of the final interview guide will be: "Could you describe your life experience and your health after being diagnosed with multiple myeloma? How do the symptoms and the disease affect your daily life? What does caring for your loved one mean to you?".
Data will be collected through semi-structured interviews conducted in person or via video call, based on participant preference and availability. All interviews will be audio-recorded, transcribed verbatim, and analyzed through the reflexive thematic analysis using an inductive approach associated to open coding. Analysis will be iterative and involve multiple researchers to ensure inter-rater reliability of the coding procedure and the methodological rigor of the analysis.
The qualitative phase analyses will be carried out at the end of each interview because, based on the themes that will emerge from each interview, we will understand when to stop recruiting.
The final analyses of the mixed methods study will be based on the comparison of the results of the quantitative phase and the results of the qualitative phase. The comparison will be performed using data triangulation or other methods depending on the level of agreement of results of both phases. From the comparison we would like to understand to what extent the results of the qualitative study confirm those of the quantitative study or if the themes that we will develop from the qualitative interviews will show other issues. This merging of the results will allow us to define a set of criteria to identify those individuals with MM and caregivers in need of support and who could benefit more from a tailored rehabilitation intervention.
- Conditions
- Multiple Myeloma (MM), Hematologic Neoplasm
- Keywords
- Quality of Life, Social Participation, Caregivers, Observational study, Qualitative Research
- Medical subject headings
- Multiple Myeloma, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start17 Jun 2025
- Primary completionJun 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07014865
- Sponsor's protocol ID
- 121/2025/OSS/AUSLRE
- Acronym
- MMYLIFE
- Status last verified
- Jun 2025
- First submitted
- 20 May 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37326501Federici 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.
PubMed 19191060Efficace 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.
PubMed 36102777LeBlanc 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.
PubMed 35262791Levasseur 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.
PubMed 35134843Pritlove 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.
PubMed 34238260
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Associated With Health-related Quality of Life and Social Participation of Patients With Multiple Myeloma and Their Caregivers: a Mixed Methods Study
- ClinicalTrials.gov ID
- NCT07014865
- Acronym / sponsor ID
- MMYLIFE / 121/2025/OSS/AUSLRE
- Conditions
- Multiple Myeloma (MM), Hematologic Neoplasm
- Keywords
- Quality of Life, Social Participation, Caregivers, Observational study, Qualitative Research
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
MM is a hematological disease caused by an uncontrolled proliferation of plasma cells. Individuals with MM are vulnerable because of the effects of systemic organ damage and the side effects of treatment. A decline in patients' functional status, the deterioration of health-related quality of life (HRQoL) and a compromised participation in everyday life was reported. Moreover, the diagnosis of MM occurs within the context of a family and it negatively affects the principal informal caregiver.
According to the International Classification of Functioning, Disability and Health, participation in daily life plays a key role in rehabilitation as it confers a sense of normalcy to life. Comprehensive rehabilitation intervention aiming at improving HRQoL and facilitating participation has never been implemented with this aim.
From previous systematic reviews, it emerges that patient reported outcomes (PRO) of individuals with MM have been studied mainly in randomized clinical trials, but also few observational studies have been published, conducting also in Italy. In the province of Reggio Emilia, population-based data concerning the HRQoL of individuals with MM have never been collected, as well as for their caregivers. Needs related to participation in everyday life of individuals with MM and their caregivers were mainly studied through qualitative approach.
Although qualitative data are essential in describing a phenomenon, it is currently not possible to quantify the degree of loss of participation in everyday life or to identify patients most at risk of social isolation. As a counterpart, qualitative approach may explain those situations that quantitative approach cannot verify (e.g., reasons behind conditions of social vulnerability). For these reasons, it seems appropriate to explore the patients' perceived HRQoL and participation from both quantitative and qualitative perspectives, as well as the caregivers' burden, by integrating these data. In this study, needs and difficulties in accomplishing the relevant activities and roles as well as the description of factors that act as facilitators or barriers to HRQoL and participation will be identified to screen patients that might benefit most from rehabilitation. Based on these data, comprehensive and tailored rehabilitation may be planned in future studies and tested for its impact on HRQoL and participation.
This is a concurrent exploratory mixed methods study that involves the use of a quantitative and a qualitative approach. The quantitative is the main study, while the qualitative is the sub-study. Participants of the qualitative study will be a sub-group of those recruited in the quantitative study. In this mixed methods study, we will recruit individuals with MM and caregivers.
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. Data collection will be performed through an individual semi-structured interview conducted in person, remotely or through self-administration, based on participant preference and availability.
As for individuals with MM, the semi-structured interview will consist in the collection of sociodemographic and work-related characteristics, while the side effects of treatments, the needs perceived from this population and the outcomes of interest will be collected through validated assessment tools. Disease-related factors will be retrieved from medical records.
As for caregivers, the semi-structured interview will consist in the collection of sociodemographic and work-related characteristics, while the outcomes of interest will be collected through validated assessment tools. The analyses of the quantitative phase will be carried out at the end of the quantitative data collection.
Qualitative Sub-Study To complement the findings of the primary quantitative study, a qualitative sub-study will be conducted to deepen the understanding of the disease-related experiences of individuals with MM and their informal caregivers and its consequences on daily life.
This qualitative sub-study is embedded within the larger concurrent exploratory mixed methods design. Participants in the qualitative phase will be a purposeful sub-sample of those already enrolled in the quantitative study, selected to ensure variation in the line of therapy (LOT), gender, and occupational status. Inclusion will aim to represent diverse patient and caregiver experiences.
In this qualitative sub-study, open-ended questions will be asked to participants by using interview guides, one for individual with MM and one for caregiver. Before conducting the qualitative interviews, a preliminary phase will be organized where researchers will involve expert patients and caregivers to support them in defining themes and questions of the interview guide. As an example, questions of the final interview guide will be: "Could you describe your life experience and your health after being diagnosed with multiple myeloma? How do the symptoms and the disease affect your daily life? What does caring for your loved one mean to you?".
Data will be collected through semi-structured interviews conducted in person or via video call, based on participant preference and availability. All interviews will be audio-recorded, transcribed verbatim, and analyzed through the reflexive thematic analysis using an inductive approach associated to open coding. Analysis will be iterative and involve multiple researchers to ensure inter-rater reliability of the coding procedure and the methodological rigor of the analysis.
The qualitative phase analyses will be carried out at the end of each interview because, based on the themes that will emerge from each interview, we will understand when to stop recruiting.
The final analyses of the mixed methods study will be based on the comparison of the results of the quantitative phase and the results of the qualitative phase. The comparison will be performed using data triangulation or other methods depending on the level of agreement of results of both phases. From the comparison we would like to understand to what extent the results of the qualitative study confirm those of the quantitative study or if the themes that we will develop from the qualitative interviews will show other issues. This merging of the results will allow us to define a set of criteria to identify those individuals with MM and caregivers in need of support and who could benefit more from a tailored rehabilitation intervention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Comorbidities that limit collaboration (e.g., dementia, severe psychiatric disorders).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Health related quality of life (HRQoL)
Time frame: 24 months
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)
Time frame: 24 months
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
Time frame: 24 months
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
Time frame: 24 months
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.
5. Self-efficacy
Time frame: 24 months
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.
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
Time frame: 24 months
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 37326501Bates-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.
- Background: PubMed 19191060Federici 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.
- Background: PubMed 36102777Efficace 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.
- Background: PubMed 35262791LeBlanc 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.
- Background: PubMed 35134843Levasseur 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.
- Background: PubMed 34238260Pritlove 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma (MM) and Hematologic Neoplasm, run by Azienda USL Reggio Emilia - IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Paltrinieri, PhD, OT (0039 0522 522416, sara.paltrinieri@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health related quality of life (HRQoL) (time frame: 24 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07014865, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.