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

Recruiting

Conditions: haematological cancer
multiple myeloma
10018849

Registration Number: NL-OMON49218

Lead Sponsor: Isala Klinieken

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

In order to be eligible to participate in this study, with informed consent, a
subject (patient) must meet all of the following criteria:

Patients meeting any of the following criteria may be included in the study:
• Females and males >*18 years;
• Diagnosis of multiple myeloma (NDMM patients);
• Able to complete outcome measures;
• Patients will be screened on minimal digital skills to check if they are able
to interact with an e-coach and whether they can read and understand the Dutch
language; estimated by the patient*s haematologist/oncologist
• Patients have their own mobile (smart)phone, computer or tablet (20 iPads are
available for exceptions)
• Every new diagnosed multiple myeloma patient qualifies for study
participation.

Exclusion Criteria

potential subject who meets any of the following criteria will be excluded from
participation in this study:
• Not prescribed oral medication for a MM treatment regime;
• Psychiatric illness requiring secondary care intervention;
• Too ill to engage with the intervention in the opinion of the clinical care
team.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary hypothesis<br /><br>We hypothesize that implementation of the e-coach MM will result in:<br /><br>-Improved treatment compliance of minimum 10 percent by pill count after 3<br /><br>months</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary hypotheses<br /><br>-Improved compliance by pill count after 12 months<br /><br>-Medication persistence after 12 months<br /><br>-Improved Quality of Life after 12 months<br /><br>(time to 10 point change will also be estimated and compared.)<br /><br>-Improved Shared Decision Making after 12 months<br /><br><br /><br>Other explorative parameters<br /><br>-Reduced hospital costs related to the treatment of MM<br /><br>-Reduced adverse events (grade III-IV)<br /><br>-Improved PFS and OS<br /><br>-Examine the consistency of the e-coach across the subgroups (FIT and NOT FIT).</p><br>