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Trial Title:
Telemonitoring Among Patients With Multiple Myeloma
NCT ID:
NCT05964270
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Conditions: Keywords:
Value-base health care
e-coach
adherence
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
A two-arm open-label parallel-group randomized controlled trial (RCT) will be conducted
at a supra regional cancer center (referred to as 'het oncologisch centrum Isala'), which
provides hematology services to a population with 0.5 million adherence and a population
of 1 million referral, in the Northern-East region of The Netherlands.
Primary purpose:
Other
Masking:
Single (Care Provider)
Masking description:
pill count
Intervention:
Intervention type:
Device
Intervention name:
e-coach multipel myeloma (MM)
Description:
In this study we developed a multimodal patient-centered MM e-coach between September
2019 and June 2020. The content of the intervention consist of eight modules and was
tested in a pilot study between June 2020 and August 2020 (F-ITUMM) 22. The e-coach is
digitally managed, following three phases of the tiers of VBHC as presented in Figure 1.
The tiers are classified in health status, process of recovery and sustainability of
health 30. Furthermore, all medication information plus current dose and frequency per
unit time are integrated in the e-coach. Reminders are sent if a session or a medication
unit time is exceeded. Feasibility was tested for patients as well as healthcare
professionals. The F-ITUMM trial concluded that the MM e-coach has the potential to
support both recently diagnosed MM patients and healthcare professionals during MM
treatment, and is a promising application to improve adherence .
Arm group label:
Intervention group (IG)
Summary:
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Isala Klinieken
Address:
City:
Zwolle
Zip:
8012AB
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Job Eijsink, PharmD
Start date:
March 1, 2021
Completion date:
July 1, 2024
Lead sponsor:
Agency:
Isala
Agency class:
Other
Source:
Isala
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05964270
