Multiple MyelomaITUMMNCT05964270
Telemonitoring Among Patients With Multiple Myeloma
A study testing e-coach multipel myeloma (MM) in people with Multiple Myeloma, run by Isala at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- e-coach multipel myeloma (MM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Mar 2021to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Peter ter Horst, PharmD,PhD contact
Netherlands1 site, 1 recruiting
- Recruiting
Isala Klinieken
Zwolle, Overijssel, 8012AB
Job Eijsink, PharmD
About this study
Official title: The Impact of Telemonitoring on Correct Drug Use, Complications and Quality of Life Among Patients With Multiple Myeloma (MM)
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.
- Conditions
- Multiple Myeloma
- Being tested
- e-coach multipel myeloma (MM)
- Keywords
- Value-base health care, e-coach, adherence
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-coach multipel myeloma (MM)Device
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 .
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (IG) | Active comparator | 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. Receives: Device: e-coach multipel myeloma (MM) |
| Control group (CG) | No intervention | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
blinded primary outcome by pill count
Measured: over a time periode of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Mar 2021
- Primary completion1 Mar 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Job Eijsink, Isala
- Investigators
- Job Eijsink, PharmD, Principal investigator, Isala klinieken department clinical pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964270
- Sponsor's protocol ID
- ITUMM
- Acronym
- ITUMM
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Eijsink JFH, Geerts PAF, Kamminga K, Edens MA, Boersma C, Postma MJ, Maring JG, Ter Horst PGJ. The impact of telemonitoring on correct drug use, complications and quality of life among patients with multiple myeloma (ITUMM): A study protocol for an open-label, parallel-group, randomized controlled trial. PLoS One. 2024 Aug 26;19(8):e0307177. doi: 10.1371/journal.pone.0307177. eCollection 2024.
PubMed 39186588
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Telemonitoring on Correct Drug Use, Complications and Quality of Life Among Patients With Multiple Myeloma (MM)
- ClinicalTrials.gov ID
- NCT05964270
- Acronym / sponsor ID
- ITUMM / ITUMM
- Conditions
- Multiple Myeloma
- Keywords
- Value-base health care, e-coach, adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- IsalaUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 27 Jul 2023 (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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (IG) | Active comparator | Device: e-coach multipel myeloma (MM)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. |
| Control group (CG) | No intervention | –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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-coach multipel myeloma (MM)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 . | Device | Intervention group (IG) |
Primary outcome
blinded primary outcome by pill count
Time frame: over a time periode of 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Derived from this study: PubMed 39186588Eijsink JFH, Geerts PAF, Kamminga K, Edens MA, Boersma C, Postma MJ, Maring JG, Ter Horst PGJ. The impact of telemonitoring on correct drug use, complications and quality of life among patients with multiple myeloma (ITUMM): A study protocol for an open-label, parallel-group, randomized controlled trial. PLoS One. 2024 Aug 26;19(8):e0307177. doi: 10.1371/journal.pone.0307177. eCollection 2024.
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
Peter ter Horst, PharmD,PhD contact
Job Eijsink, PharmD principal investigator
Isala klinieken department clinical pharmacy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-coach multipel myeloma (MM) in people with Multiple Myeloma, run by Isala at 1 site in Netherlands.
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 11 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 27 Jul 2023. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Job Eijsink, PharmD (0618885254, j.f.h.eijsink@isala.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blinded primary outcome by pill count (time frame: over a time periode of 3 months). 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 NCT05964270, which also lists 1 linked publication.
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 27 Jul 2023.