Clinical trial NCT04595955: Effects of a Digital Patient Platform (CMyLife) for Patients With Chronic Myeloid Leukemia (CML) on Information Provision, Patient Empowerment, Medication Compliance, Guideline Adherence and Quality of Life
Official title: Effectiveness of the Digital Patient Platform CMyLife for Patients With Chronic Myeloid Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Chronic Myeloid Leukemia
Patient Portals
Telemedicine
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A controlled before-after study is performed in order to gain insights into the effectiveness of the CMyLife platform in terms of medication compliance, guideline adherence, quality of life, information provision and patient empowerment. Participants who agreed to use the CMyLife platform for at least 6 months, were enrolled in the treatment group and participants who did not agree to use the platform were enrolled in the control group. After signing informed consent, participants received a baseline questionnaire by mail. Upon completion of the baseline questionnaire, participants used (intervention group) or did not use (control group) the CMyLife platform for at least 6 months, after which they were asked to complete the post-intervention questionnaire.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed CML patients in chronic phase CML
* Participants were treated with first or second line TKI's at the haematology department of the participating hospitals. Patients treated with second line TKI's were only allowed to participate if they switched TKI's as a result of side effects and not if they did not respond to the first line TKI

Exclusion Criteria:

* Participants in acceleration phase
* Participants in blastcrise
* Participants with planned pregnancy in the study period

Primary outcomes:
measure: the information received by CML patients
timeFrame: at baseline
measure: the information received by CML patients
timeFrame: 6 months after baseline
measure: patient empowerment
timeFrame: at baseline
measure: patient empowerment
timeFrame: 6 months after baseline
measure: eHealth Literacy
timeFrame: at baseline
measure: eHealth Literacy
timeFrame: 6 months after baseline
measure: medication compliance
timeFrame: at baseline
measure: medication compliance
timeFrame: 6 months after baseline
measure: guideline adherence
timeFrame: at baseline
measure: guideline adherence
timeFrame: 6 months after baseline
measure: Patients' experiences
timeFrame: at baseline
measure: Patients' experiences
timeFrame: 6 months after baseline
measure: Quality of life of CML patients: EORTC QLQ-C30
timeFrame: at baseline
measure: Quality of life of CML patients: EORTC QLQ-C30
timeFrame: 6 months after baseline
measure: disease (CML) specific quality of life: EORTC QLQ-CML24
timeFrame: at baseline
measure: disease (CML) specific quality of life: EORTC QLQ-CML24
timeFrame: 6 months after baseline
Secondary outcomes:
measure: Familiarity with CML related concept: Philadelphia chromosome
timeFrame: at baseline
measure: Familiarity with CML related concept: Philadelphia chromosome
timeFrame: 6 months after baseline
measure: Familiarity with CML related concept: BCR-ABL
timeFrame: at baseline
measure: Familiarity with CML related concept: BCR-ABL
timeFrame: 6 months after baseline
measure: Familiarity with CML related concept: tyrosine kinase inhibitor
timeFrame: at baseline
measure: Familiarity with CML related concept: tyrosine kinase inhibitor
timeFrame: 6 months after baseline
measure: Familiarity with CML related concept: remission
timeFrame: at baseline
measure: Familiarity with CML related concept: remission
timeFrame: 6 months after baseline
measure: Familiarity with CML related concept: log reduction
timeFrame: at baseline
measure: Familiarity with CML related concept: log reduction
timeFrame: 6 months after baseline
measure: Familiarity with CML related concept: hematologic response/remission
timeFrame: at baseline
measure: Familiarity with CML related concept: hematologic response/remission
timeFrame: 6 months after baseline
measure: Familiarity with CML related concept: cytogenetic response/remission
timeFrame: at baseline
measure: Familiarity with CML related concept: cytogenetic response/remission
timeFrame: 6 months after baseline
measure: Familiarity with CML related concept: molecular response/remission
timeFrame: at baseline
measure: Familiarity with CML related concept: molecular response/remission
timeFrame: 6 months after baseline
measure: Familiarity with CML related concept: major molecular remission
timeFrame: at baseline
measure: Familiarity with CML related concept: major molecular remission
timeFrame: 6 months after baseline
measure: Familiarity with CML related concept: complete cytogenetic remission
timeFrame: at baseline
measure: Familiarity with CML related concept: complete cytogenetic remission
timeFrame: 6 months after baseline
measure: Familiarity with CML related concept: treatment free remission
timeFrame: at baseline
measure: Familiarity with CML related concept: treatment free remission
timeFrame: 6 months after baseline
measure: Familiarity with CML related concept: Hematon
timeFrame: at baseline
measure: Familiarity with CML related concept: Hematon
timeFrame: 6 months after baseline
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
References: