xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05964270</url>
    </required_header>
    <id_info>
      <org_study_id>ITUMM</org_study_id>
      <nct_id>NCT05964270</nct_id>
    </id_info>
    <brief_title>Telemonitoring Among Patients With Multiple Myeloma</brief_title>
    <acronym>ITUMM</acronym>
    <official_title>The Impact of Telemonitoring on Correct Drug Use, Complications and Quality of Life Among Patients With Multiple Myeloma (MM)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Isala</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Isala</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A two-arm open-label parallel-group randomized controlled trial will be conducted to compare&#xD;
        the telemonitoring (MM e-coach) with standard MM care. This study aimed to recruit 150&#xD;
        patients with recently diagnosed multiple myeloma (RDMM), starting first or second line of&#xD;
        treatment. Blinded primary outcome is adherence by pill count after start of treatment at 1-3&#xD;
        months. Secondary outcomes are patient reported outcomes: Groninger frailty index (GFI),&#xD;
        quality of life (EQ-5D-5L, EORTC-QLQ-C30), shared decision making (SDM-Q-9), self-reported&#xD;
        adherence (MARS-5), single item questions, patient experiences (PREMs), adverse events,&#xD;
        overall survival (OS) and progression free survival (PFS). Patient reported outcomes were&#xD;
        developed and integrated in the e-coach MM to regularly measure digitized outcomes of MM&#xD;
        patients from time of RDMM until 12 months post-diagnosis. Online measurements will be&#xD;
        performed at baseline (0), 3, 6, 9 and 12 months.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">March 1, 2021</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <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.</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Care Provider)</masking>
      <masking_description>pill count</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>blinded primary outcome by pill count</measure>
      <time_frame>over a time periode of 3 months</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Multiple Myeloma</condition>
    <arm_group>
      <arm_group_label>Intervention group (IG)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group (CG)</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <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</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>e-coach multipel myeloma (MM)</intervention_name>
      <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 .</description>
      <arm_group_label>Intervention group (IG)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          In order to be eligible to participate in this study, a participant (patient) must meet all&#xD;
          of the -following criteria:&#xD;
  &#xD;
            -  signed informed consent&#xD;
  &#xD;
            -  &gt;18 years&#xD;
  &#xD;
            -  recently diagnosed MM patients with first-line or second-line treatment&#xD;
  &#xD;
            -  able to complete patient-reported outcome measures and experiences&#xD;
  &#xD;
            -  have minimal digital skills to check if they are able to interact with an e-coach&#xD;
  &#xD;
            -  can read and understand Dutch.&#xD;
  &#xD;
          Participants who meet any of the following criteria will be excluded from participation in&#xD;
          this study&#xD;
  &#xD;
            -  psychiatric illness requiring secondary-care intervention&#xD;
  &#xD;
            -  too ill to engage with the intervention in the opinion of the clinical care team&#xD;
  &#xD;
            -  no perspective of &gt;12 months survival.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Job Eijsink, PharmD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Isala klinieken department clinical pharmacy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Job Eijsink, PharmD</last_name>
      <phone>0618885254</phone>
      <email>j.f.h.eijsink@isala.nl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Peter ter Horst, PharmD,PhD</last_name>
      <phone>088 624 5000</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Isala Klinieken</name>
        <address>
          <city>Zwolle</city>
          <state>Overijssel</state>
          <zip>8012AB</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Job Eijsink, PharmD</last_name>
      </contact>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 26, 2023</last_update_submitted>
    <last_update_submitted_qc>July 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Isala</investigator_affiliation>
      <investigator_full_name>Job Eijsink</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Value-base health care</keyword>
    <keyword>e-coach</keyword>
    <keyword>adherence</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Multiple Myeloma</mesh_term>
      <mesh_term>Neoplasms, Plasma Cell</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05964270
  org study id: ITUMM
  nct id: NCT05964270
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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
  measure: blinded primary outcome by pill count
  time frame: over a time periode of 3 months
  arm group label: Intervention group (IG)
  arm group type: Active Comparator
  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.
  arm group label: Control group (CG)
  arm group type: No Intervention
  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
  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)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Job Eijsink, PharmD
  role: Principal Investigator
  affiliation: Isala klinieken department clinical pharmacy
  last name: Job Eijsink, PharmD
  phone: 0618885254
  email: j.f.h.eijsink@isala.nl
  last name: Peter ter Horst, PharmD,PhD
  phone: 088 624 5000
  facility: 
  status: Recruiting
  contact: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Isala
  investigator full name: Job Eijsink
  investigator title: Principal Investigator
  mesh term: Multiple Myeloma
  mesh term: Neoplasms, Plasma Cell
  sharing ipd: Yes
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)