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

Not Applicable

Completed

• Conditions: Neoplasms; Patient Portals; Chronic Myeloid Leukemia; Telemedicine
• Interventions: Other: CMyLife

• Registration Number: NCT04595955
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Primary Completion: 2020-08-31
• Study Completion: 2020-08-31
• Status Verified: 2020-09
• Study First Submitted: 2020-10-08
• Study First Submitted QC: 2020-10-16
• Last Update Submitted: 2020-10-16
• Study First Posted: 2020-10-22
• Last Update Posted: 2020-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Read More

Exclusion Criteria

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	CMyLife	This arm uses the CMyLife platform for at least 6 months

Primary Outcome Measures

Name	Time	Method
Patients' experiences	6 months after baseline	Participants' experiences with the care and information they receive in hospitals for their CML were measured using Patient Reported Experience Measures
Quality of life of CML patients: EORTC QLQ-C30	6 months after baseline	Quality of life of participants was measured using the EORTC QLQ-C30
the information received by CML patients	6 months after baseline	To evaluate the information received by participants the EORTC QLQ-INFO25 was used
eHealth Literacy	6 months after baseline	Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale
patient empowerment	6 months after baseline	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
medication compliance	6 months after baseline	medication compliance of participants was measured using the Medication Adherence Rating Scale
disease (CML) specific quality of life: EORTC QLQ-CML24	6 months after baseline	disease specific quality of life of participants was measured using the EORTC QLQ-CML24
guideline adherence	6 months after baseline	guideline adherence was measured using the frequency of BCR-ABL1 value checks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Gelderland, Netherlands