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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
99

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Netherlands
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention group
This arm uses the CMyLife platform for at least 6 months
Other: CMyLife
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Radboud University Medical Center

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 22, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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