Telemonitoring Among Patients With Multiple Myeloma (ITUMM)

Isala

Status: Enrolling

Conditions: Multiple Myeloma

Treatments: Device: e-coach multipel myeloma (MM)

Study type: Interventional

Funder types: Other

Identifiers

NCT05964270

ITUMM

Details and patient eligibility

About

A two-arm open-label parallel-group randomized controlled trial will be conducted to compare the telemonitoring (MM e-coach) with standard MM care. This study aimed to recruit 150 patients with recently diagnosed multiple myeloma (RDMM), starting first or second line of treatment. Blinded primary outcome is adherence by pill count after start of treatment at 1-3 months. Secondary outcomes are patient reported outcomes: Groninger frailty index (GFI), quality of life (EQ-5D-5L, EORTC-QLQ-C30), shared decision making (SDM-Q-9), self-reported adherence (MARS-5), single item questions, patient experiences (PREMs), adverse events, overall survival (OS) and progression free survival (PFS). Patient reported outcomes were developed and integrated in the e-coach MM to regularly measure digitized outcomes of MM patients from time of RDMM until 12 months post-diagnosis. Online measurements will be performed at baseline (0), 3, 6, 9 and 12 months.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

In order to be eligible to participate in this study, a participant (patient) must meet all of the -following criteria:

• signed informed consent
• >18 years
• recently diagnosed MM patients with first-line or second-line treatment
• able to complete patient-reported outcome measures and experiences
• have minimal digital skills to check if they are able to interact with an e-coach
• can read and understand Dutch.

Participants who meet any of the following criteria will be excluded from participation in this study

• psychiatric illness requiring secondary-care intervention
• too ill to engage with the intervention in the opinion of the clinical care team
• no perspective of >12 months survival.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Intervention group (IG)

Active Comparator group

Description:

participants of the intervention group (IG) will get a login for the e-coach MM, and access to eight modules: medication, outpatient visit preparation, periodic assessment, messaging service, alerts, information, ad hoc complaint, personal care plan. IG participants information is collected on a web platform that automatically invites enrolled patients. The e-coach MM is available 24/7.

Treatment:

Device: e-coach multipel myeloma (MM)

Control group (CG)

No Intervention group

Description:

Participants in the CG (control group) will only get a login for a 'dummy version' without the modules, besides the periodic assessments (questionnaires), at the same time as the IG