The Impact of Telemonitoring on correct drug Use, complications and quality of life among patients with Multiple Myeloma (MM);(ITUMM)

Rationale: Multiple myeloma (MM) is the uncontrolled division of malignant
plasma cells in bone marrow tissue. It is the second most common haematological
cancer in the Western world. About 1000 people in the Netherlands are diagnosed
with MM each year [1]. There are around 4000 patients with this disease in the
Netherlands. It mainly concerns people over 60 years old (80%) and there are
slightly more men than women with MM [34]. A recent study has shown that the
median survival varies from 37.5 months (95% confidence interval: 34.8-41.8
months) in the first line to 9.2 months (95% CI: 6.2-12.3 months) in the 4th
line treatment regimens [2]. Although the intention to compliance, for complex
MM drugs regimens, seems higher than other chronic diseases [3]. The complexity
of the treatment regimens requires continuous effort and attention from the
patient when taking the medication. An e-coach could possibly contribute to
compliance [4,5].
Objective: The objective of this study is to compare the impact of a
multicomponent self-management tool, using an e-coach versus care as usual.
Using the MM e-coach may expected to increase patients compliance on correct
drug use, improving the Quality of Life, reduce complications and MM related
treatment costs.
Endpoints: The compliance by pill count after 3 months, of newly diagnosed MM
(NDMM) patients is the primary endpoint. Secondary endpoints are the compliance
by pill count after 12 months, Persistence by Portion Days Covered (PDC),
Medication Adherence Rating Scale (MARS-5), Quality of Life (EQ-5D and
EORTC-QLQC30), Shared Decision Making (SDM-Q-9), Other explorative study
parameters are: single items for MM specific Patient Reported Experience
(PREMS), and MM specific Patient Reported Outcomes (PROMS), according to the
concept of Value-Based Health Care (VBHC). (like single item *sexual
functioning* or single item: *pain*), adverse events (grade III-IV), hospital
admission related to the treatment of MM, hospital costs related to the
treatment of MM. Additional explorative endpoints are; PFS (36 months) and OS
(at 5 years).
Study design: This study contains a single centre, randomized controlled trial
(RCT). NDMM patients scheduled for infusion- and oral-based (chemo) therapy
will be included in the study. Patients will be randomly divided over two arms:
the intervention group will be treated with e-coach assistance; the control
group will receive care as usual.
Study population: Patients will be treated for MM according to local standard
of care including supportive care (infection prophylaxis, thrombosis
prophylaxis). Patients will be screened on minimal digital skills to check if
they are able/or can be trained to interact with an e-coach and whether they
can read the Dutch language.
E-coach: The intervention consists of intensified support on correct intake of
medication by using an e-coach combined with e-consulting. The e-coach consists
of a medication assistance part coupled to the EMR/oncology prescription
system, a diary part (to register disease burden and scores), e-learnings and
it provides the possibility to connect directly with health care professionals
(nurse specialist/physician assistant/medical oncologist/pharmacist) by
e-consulting. Feedback to the professionals is given based on e-coach alerts,
medication adherence questionnaire outcomes and pill counts, with lower
potentially avoidable hospital admissions.
Relevance for practice:
There is potential and, from a safety perspective, medical need for
multi-component intervention strategies to improve the medication adherence in
patients treated with complex oral-based chemotherapy schedules.
The MM e-coach project must deliver a blueprint for future disease specific
e-coaches to monitor complex pharmacotherapy at home.

• E-coach MM in a broader context (other hospitals and care outside the
hospital)
• E-coaching in other diseases, with complex drugs regimes.

The main objective of the project is to study difference between compliance by
pill count after 3 months by newly diagnosed multiple myeloma (NDMM) patients
with an innovative e-coach, in order to improve treatment compliance by the
intervention group compared to the control group. Secondary
objectives:compliance by pill count after 12 months, medication persistence
(PDC), MARS-5, evaluate Quality of Life after 12 months, improved Shared
Decision Making, PROMs and PREMs, Progression Free Survival, Overall Survival,
adverse events, hospital admissions (hospitalization linked to oncology
treatment) and hospital costs. 10% difference in compliance between
intervention group (e-coach MM) versus control group (care as usual) is
feasible and clinically meaningful

This is a single site RCT in 150 MM patients to study differences in compliance
by pill count, and evaluate: compliance by pill count after 3 months and after
12 months of treatment, medication persistence (PDC), MARS-5, evaluate Quality
of Life, improved Shared Decision Making, PROMs and PREMs, Progression Free
Survival, Overall Survival, adverse events, hospital admissions
(hospitalization linked to oncology treatment) and hospital costs.
Every NDMM patient qualifies for study participation. Multiple Myeloma
patients scheduled for treatment with I.V., S.Q. -and oral-based (chemo)
therapy will be recruited and selected on fit (18-70 years) or not fit (> 70
years) iDoc protocol 110769 and is conform the HOVON guideline. A FIT patient
is eligible for stem cell transplantation, which affects the total treatment
options and survival rate compared to a NOT FIT. FIT versus NOT FIT is mainly
determined by age as determined in the Dutch HOVON Multiple Myeloma Guideline.
This guidance is also used in treatment protocols in Dutch hospitals. The
threshold to be eligible for autoHSCT is younger than 70 years of age according
to this guideline. In addition, a frailty index score has been included in the
RCT, which is planned in a multidisciplinary meeting shortly after a diagnosis.
In the RCT the age limit of 70 years is used with a high frailty index as *not
fit*, all patients who are younger and score well on the frailty index, are
therefore eligible for a bone marrow transplant and more options with regard to
medication. It is important to mention that a care provider and in particular
the multidisciplinary meeting is important, in this case the team can decide
whether a patient who is on the limit of the criteria can be treated in the fit
group.
After the patients will be treated for MM according to local standard of care
including supportive care (infection prophylaxis, thrombosis prophylaxis).
Patients will be screened on minimal digital skills by the healthcare
professional, to check if they are able/or can be trained to interact with an
e-coach and whether they can read the Dutch language. Patients will enter the
new care path to the study for 12 months. We expect 50-75 new diagnosed
patients each year. After 12 months follow-up per patient, we will evaluate if
the preliminary results contain the expectations and make a shift from the RCT
to care as usual with integration of the e-coach in the care pathway.

Patiënten vullen vragenlijsten in en kunnen op de gewenste tijdstippen (waarin
ze begeleid worden) de medicatie innemen.