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

Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04595955
• Other study ID #: RU_23-08-20_LV
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: August 31, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid
• Neoplasms
• Patient Portals
• Telemedicine

Intervention

Other:
• CMyLife
CMyLife is a digital patient platform for Patients With Chronic Myeloid Leukemia.

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the information received by CML patients	To evaluate the information received by participants the EORTC QLQ-INFO25 was used	at baseline
Primary	the information received by CML patients	To evaluate the information received by participants the EORTC QLQ-INFO25 was used	6 months after baseline
Primary	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
Primary	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
Primary	eHealth Literacy	Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale	at baseline
Primary	eHealth Literacy	Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale	6 months after baseline
Primary	medication compliance	medication compliance of participants was measured using the Medication Adherence Rating Scale	at baseline
Primary	medication compliance	medication compliance of participants was measured using the Medication Adherence Rating Scale	6 months after baseline
Primary	guideline adherence	guideline adherence was measured using the frequency of BCR-ABL1 value checks	at baseline
Primary	guideline adherence	guideline adherence was measured using the frequency of BCR-ABL1 value checks	6 months after baseline
Primary	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
Primary	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
Primary	Quality of life of CML patients: EORTC QLQ-C30	Quality of life of participants was measured using the EORTC QLQ-C30	at baseline
Primary	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
Primary	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
Primary	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	Familiarity with CML related concept: Philadelphia chromosome	% of participants who are not (at all) familiar with the concept Philadelphia chromosome	at baseline
Secondary	Familiarity with CML related concept: Philadelphia chromosome	% of participants who are not (at all) familiar with the concept Philadelphia chromosome	6 months after baseline
Secondary	Familiarity with CML related concept: BCR-ABL	% of participants who are not (at all) familiar with the concept BCR-ABL	at baseline
Secondary	Familiarity with CML related concept: BCR-ABL	% of participants who are not (at all) familiar with the concept BCR-ABL	6 months after baseline
Secondary	Familiarity with CML related concept: tyrosine kinase inhibitor	% of participants who are not (at all) familiar with the concept tyrosine kinase inhibitor	at baseline
Secondary	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
Secondary	Familiarity with CML related concept: remission	% of participants who are not (at all) familiar with the concept remission	at baseline
Secondary	Familiarity with CML related concept: remission	% of participants who are not (at all) familiar with the concept remission	6 months after baseline
Secondary	Familiarity with CML related concept: log reduction	% of participants who are not (at all) familiar with the concept log reduction	at baseline
Secondary	Familiarity with CML related concept: log reduction	% of participants who are not (at all) familiar with the concept log reduction	6 months after baseline
Secondary	Familiarity with CML related concept: hematologic response/remission	% of participants who are not (at all) familiar with the concept hematologic response/remission	at baseline
Secondary	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
Secondary	Familiarity with CML related concept: cytogenetic response/remission	% of participants who are not (at all) familiar with the concept cytogenetic response/remission	at baseline
Secondary	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
Secondary	Familiarity with CML related concept: molecular response/remission	% of participants who are not (at all) familiar with the concept molecular response/remission	at baseline
Secondary	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
Secondary	Familiarity with CML related concept: major molecular remission	% of participants who are not (at all) familiar with the concept major molecular remission	at baseline
Secondary	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
Secondary	Familiarity with CML related concept: complete cytogenetic remission	% of participants who are not (at all) familiar with the concept complete cytogenetic remission	at baseline
Secondary	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
Secondary	Familiarity with CML related concept: treatment free remission	% of participants who are not (at all) familiar with the concept treatment free remission	at baseline
Secondary	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
Secondary	Familiarity with CML related concept: Hematon	% of participants who are not (at all) familiar with the concept hematon	at baseline
Secondary	Familiarity with CML related concept: Hematon	% of participants who are not (at all) familiar with the concept hematon	6 months after baseline