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

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of the Digital Patient Platform CMyLife for Patients With Chronic Myeloid Leukemia

Conditions
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Neoplasms, Chronic Myeloid Leukemia, Patient Portals, Telemedicine

Intervention / Treatment
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* Other: CMyLife


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>This arm uses the CMyLife platform for at least 6 months | Other: CMyLife<br>* CMyLife is a digital patient platform for Patients With Chronic Myeloid Leukemia.<br>|
| No Intervention: Control group<br>This arm does not use the CMyLife platform | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the information received by CML patients | To evaluate the information received by participants the EORTC QLQ-INFO25 was used | at baseline | 
| the information received by CML patients | To evaluate the information received by participants the EORTC QLQ-INFO25 was used | 6 months after baseline | 
| patient empowerment | The Patient Activation Measure was used to gain more insight into how and to what extent the participant believed that he/she is able to improve his/her own health | at baseline | 
| patient empowerment | The Patient Activation Measure was used to gain more insight into how and to what extent the participant believed that he/she is able to improve his/her own health | 6 months after baseline | 
| eHealth Literacy | Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale | at baseline | 
| eHealth Literacy | Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale | 6 months after baseline | 
| medication compliance | medication compliance of participants was measured using the Medication Adherence Rating Scale | at baseline | 
| medication compliance | medication compliance of participants was measured using the Medication Adherence Rating Scale | 6 months after baseline | 
| guideline adherence | guideline adherence was measured using the frequency of BCR-ABL1 value checks | at baseline | 
| guideline adherence | guideline adherence was measured using the frequency of BCR-ABL1 value checks | 6 months after baseline | 
| Patients' experiences | Participants' experiences with the care and information they receive in hospitals for their CML were measured using Patient Reported Experience Measures | at baseline | 
| Patients' experiences | Participants' experiences with the care and information they receive in hospitals for their CML were measured using Patient Reported Experience Measures | 6 months after baseline | 
| Quality of life of CML patients: EORTC QLQ-C30 | Quality of life of participants was measured using the EORTC QLQ-C30 | at baseline | 
| Quality of life of CML patients: EORTC QLQ-C30 | Quality of life of participants was measured using the EORTC QLQ-C30 | 6 months after baseline | 
| disease (CML) specific quality of life: EORTC QLQ-CML24 | disease specific quality of life of participants was measured using the EORTC QLQ-CML24 | at baseline | 
| disease (CML) specific quality of life: EORTC QLQ-CML24 | disease specific quality of life of participants was measured using the EORTC QLQ-CML24 | 6 months after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Familiarity with CML related concept: Philadelphia chromosome | % of participants who are not (at all) familiar with the concept Philadelphia chromosome | at baseline | 
| Familiarity with CML related concept: Philadelphia chromosome | % of participants who are not (at all) familiar with the concept Philadelphia chromosome | 6 months after baseline | 
| Familiarity with CML related concept: BCR-ABL | % of participants who are not (at all) familiar with the concept BCR-ABL | at baseline | 
| Familiarity with CML related concept: BCR-ABL | % of participants who are not (at all) familiar with the concept BCR-ABL | 6 months after baseline | 
| Familiarity with CML related concept: tyrosine kinase inhibitor | % of participants who are not (at all) familiar with the concept tyrosine kinase inhibitor | at baseline | 
| Familiarity with CML related concept: tyrosine kinase inhibitor | % of participants who are not (at all) familiar with the concept tyrosine kinase inhibitor | 6 months after baseline | 
| Familiarity with CML related concept: remission | % of participants who are not (at all) familiar with the concept remission | at baseline | 
| Familiarity with CML related concept: remission | % of participants who are not (at all) familiar with the concept remission | 6 months after baseline | 
| Familiarity with CML related concept: log reduction | % of participants who are not (at all) familiar with the concept log reduction | at baseline | 
| Familiarity with CML related concept: log reduction | % of participants who are not (at all) familiar with the concept log reduction | 6 months after baseline | 
| Familiarity with CML related concept: hematologic response/remission | % of participants who are not (at all) familiar with the concept hematologic response/remission | at baseline | 
| Familiarity with CML related concept: hematologic response/remission | % of participants who are not (at all) familiar with the concept hematologic response/remission | 6 months after baseline | 
| Familiarity with CML related concept: cytogenetic response/remission | % of participants who are not (at all) familiar with the concept cytogenetic response/remission | at baseline | 
| Familiarity with CML related concept: cytogenetic response/remission | % of participants who are not (at all) familiar with the concept cytogenetic response/remission | 6 months after baseline | 
| Familiarity with CML related concept: molecular response/remission | % of participants who are not (at all) familiar with the concept molecular response/remission | at baseline | 
| Familiarity with CML related concept: molecular response/remission | % of participants who are not (at all) familiar with the concept molecular response/remission | 6 months after baseline | 
| Familiarity with CML related concept: major molecular remission | % of participants who are not (at all) familiar with the concept major molecular remission | at baseline | 
| Familiarity with CML related concept: major molecular remission | % of participants who are not (at all) familiar with the concept major molecular remission | 6 months after baseline | 
| Familiarity with CML related concept: complete cytogenetic remission | % of participants who are not (at all) familiar with the concept complete cytogenetic remission | at baseline | 
| Familiarity with CML related concept: complete cytogenetic remission | % of participants who are not (at all) familiar with the concept complete cytogenetic remission | 6 months after baseline | 
| Familiarity with CML related concept: treatment free remission | % of participants who are not (at all) familiar with the concept treatment free remission | at baseline | 
| Familiarity with CML related concept: treatment free remission | % of participants who are not (at all) familiar with the concept treatment free remission | 6 months after baseline | 
| Familiarity with CML related concept: Hematon | % of participants who are not (at all) familiar with the concept hematon | at baseline | 
| Familiarity with CML related concept: Hematon | % of participants who are not (at all) familiar with the concept hematon | 6 months after baseline |