- ICH GCP
- US Clinical Trials Registry
- 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
October 16, 2020 updated by: Radboud University Medical Center
Effectiveness of the Digital Patient Platform CMyLife for Patients With Chronic Myeloid Leukemia
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
99
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Gelderland
-
Nijmegen, Gelderland, Netherlands, 6525 GA
- Radboudumc
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
This arm uses the CMyLife platform for at least 6 months
|
CMyLife is a digital patient platform for Patients With Chronic Myeloid Leukemia.
|
No Intervention: Control group
This arm does not use the CMyLife platform
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
the information received by CML patients
Time Frame: at baseline
|
To evaluate the information received by participants the EORTC QLQ-INFO25 was used
|
at baseline
|
the information received by CML patients
Time Frame: 6 months after baseline
|
To evaluate the information received by participants the EORTC QLQ-INFO25 was used
|
6 months after baseline
|
patient empowerment
Time Frame: at 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
|
at baseline
|
patient empowerment
Time Frame: 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
|
6 months after baseline
|
eHealth Literacy
Time Frame: at baseline
|
Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale
|
at baseline
|
eHealth Literacy
Time Frame: 6 months after baseline
|
Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale
|
6 months after baseline
|
medication compliance
Time Frame: at baseline
|
medication compliance of participants was measured using the Medication Adherence Rating Scale
|
at baseline
|
medication compliance
Time Frame: 6 months after baseline
|
medication compliance of participants was measured using the Medication Adherence Rating Scale
|
6 months after baseline
|
guideline adherence
Time Frame: at baseline
|
guideline adherence was measured using the frequency of BCR-ABL1 value checks
|
at baseline
|
guideline adherence
Time Frame: 6 months after baseline
|
guideline adherence was measured using the frequency of BCR-ABL1 value checks
|
6 months after baseline
|
Patients' experiences
Time Frame: at baseline
|
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
Time Frame: 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
|
6 months after baseline
|
Quality of life of CML patients: EORTC QLQ-C30
Time Frame: at baseline
|
Quality of life of participants was measured using the EORTC QLQ-C30
|
at baseline
|
Quality of life of CML patients: EORTC QLQ-C30
Time Frame: 6 months after baseline
|
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
Time Frame: at baseline
|
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
Time Frame: 6 months after baseline
|
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
Time Frame: at baseline
|
% of participants who are not (at all) familiar with the concept Philadelphia chromosome
|
at baseline
|
Familiarity with CML related concept: Philadelphia chromosome
Time Frame: 6 months after baseline
|
% of participants who are not (at all) familiar with the concept Philadelphia chromosome
|
6 months after baseline
|
Familiarity with CML related concept: BCR-ABL
Time Frame: at baseline
|
% of participants who are not (at all) familiar with the concept BCR-ABL
|
at baseline
|
Familiarity with CML related concept: BCR-ABL
Time Frame: 6 months after baseline
|
% 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
Time Frame: at baseline
|
% of participants who are not (at all) familiar with the concept tyrosine kinase inhibitor
|
at baseline
|
Familiarity with CML related concept: tyrosine kinase inhibitor
Time Frame: 6 months after baseline
|
% of participants who are not (at all) familiar with the concept tyrosine kinase inhibitor
|
6 months after baseline
|
Familiarity with CML related concept: remission
Time Frame: at baseline
|
% of participants who are not (at all) familiar with the concept remission
|
at baseline
|
Familiarity with CML related concept: remission
Time Frame: 6 months after baseline
|
% of participants who are not (at all) familiar with the concept remission
|
6 months after baseline
|
Familiarity with CML related concept: log reduction
Time Frame: at baseline
|
% of participants who are not (at all) familiar with the concept log reduction
|
at baseline
|
Familiarity with CML related concept: log reduction
Time Frame: 6 months after baseline
|
% 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
Time Frame: at baseline
|
% of participants who are not (at all) familiar with the concept hematologic response/remission
|
at baseline
|
Familiarity with CML related concept: hematologic response/remission
Time Frame: 6 months after baseline
|
% 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
Time Frame: at baseline
|
% of participants who are not (at all) familiar with the concept cytogenetic response/remission
|
at baseline
|
Familiarity with CML related concept: cytogenetic response/remission
Time Frame: 6 months after baseline
|
% 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
Time Frame: at baseline
|
% of participants who are not (at all) familiar with the concept molecular response/remission
|
at baseline
|
Familiarity with CML related concept: molecular response/remission
Time Frame: 6 months after baseline
|
% 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
Time Frame: at baseline
|
% of participants who are not (at all) familiar with the concept major molecular remission
|
at baseline
|
Familiarity with CML related concept: major molecular remission
Time Frame: 6 months after baseline
|
% 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
Time Frame: at baseline
|
% of participants who are not (at all) familiar with the concept complete cytogenetic remission
|
at baseline
|
Familiarity with CML related concept: complete cytogenetic remission
Time Frame: 6 months after baseline
|
% 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
Time Frame: at baseline
|
% of participants who are not (at all) familiar with the concept treatment free remission
|
at baseline
|
Familiarity with CML related concept: treatment free remission
Time Frame: 6 months after baseline
|
% of participants who are not (at all) familiar with the concept treatment free remission
|
6 months after baseline
|
Familiarity with CML related concept: Hematon
Time Frame: at baseline
|
% of participants who are not (at all) familiar with the concept hematon
|
at baseline
|
Familiarity with CML related concept: Hematon
Time Frame: 6 months after baseline
|
% of participants who are not (at all) familiar with the concept hematon
|
6 months after baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2019
Primary Completion (Actual)
August 31, 2020
Study Completion (Actual)
August 31, 2020
Study Registration Dates
First Submitted
October 8, 2020
First Submitted That Met QC Criteria
October 16, 2020
First Posted (Actual)
October 22, 2020
Study Record Updates
Last Update Posted (Actual)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 16, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RU_23-08-20_LV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
The plan is to share IPD when Radboudumc arranged this possibility.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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