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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

Primary Purpose

Neoplasms, Chronic Myeloid Leukemia, Patient Portals

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
CMyLife
Sponsored by
Radboud University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Radboudumc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

This arm uses the CMyLife platform for at least 6 months

This arm does not use the CMyLife platform

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 8, 2020
Last Updated
October 16, 2020
Sponsor
Radboud University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04595955
Brief Title
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
Official Title
Effectiveness of the Digital Patient Platform CMyLife for Patients With Chronic Myeloid Leukemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radboud University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Chronic Myeloid Leukemia, Patient Portals, Telemedicine

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
This arm uses the CMyLife platform for at least 6 months
Arm Title
Control group
Arm Type
No Intervention
Arm Description
This arm does not use the CMyLife platform
Intervention Type
Other
Intervention Name(s)
CMyLife
Intervention Description
CMyLife is a digital patient platform for Patients With Chronic Myeloid Leukemia.
Primary Outcome Measure Information:
Title
the information received by CML patients
Description
To evaluate the information received by participants the EORTC QLQ-INFO25 was used
Time Frame
at baseline
Title
the information received by CML patients
Description
To evaluate the information received by participants the EORTC QLQ-INFO25 was used
Time Frame
6 months after baseline
Title
patient empowerment
Description
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
Time Frame
at baseline
Title
patient empowerment
Description
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
Time Frame
6 months after baseline
Title
eHealth Literacy
Description
Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale
Time Frame
at baseline
Title
eHealth Literacy
Description
Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale
Time Frame
6 months after baseline
Title
medication compliance
Description
medication compliance of participants was measured using the Medication Adherence Rating Scale
Time Frame
at baseline
Title
medication compliance
Description
medication compliance of participants was measured using the Medication Adherence Rating Scale
Time Frame
6 months after baseline
Title
guideline adherence
Description
guideline adherence was measured using the frequency of BCR-ABL1 value checks
Time Frame
at baseline
Title
guideline adherence
Description
guideline adherence was measured using the frequency of BCR-ABL1 value checks
Time Frame
6 months after baseline
Title
Patients' experiences
Description
Participants' experiences with the care and information they receive in hospitals for their CML were measured using Patient Reported Experience Measures
Time Frame
at baseline
Title
Patients' experiences
Description
Participants' experiences with the care and information they receive in hospitals for their CML were measured using Patient Reported Experience Measures
Time Frame
6 months after baseline
Title
Quality of life of CML patients: EORTC QLQ-C30
Description
Quality of life of participants was measured using the EORTC QLQ-C30
Time Frame
at baseline
Title
Quality of life of CML patients: EORTC QLQ-C30
Description
Quality of life of participants was measured using the EORTC QLQ-C30
Time Frame
6 months after baseline
Title
disease (CML) specific quality of life: EORTC QLQ-CML24
Description
disease specific quality of life of participants was measured using the EORTC QLQ-CML24
Time Frame
at baseline
Title
disease (CML) specific quality of life: EORTC QLQ-CML24
Description
disease specific quality of life of participants was measured using the EORTC QLQ-CML24
Time Frame
6 months after baseline
Secondary Outcome Measure Information:
Title
Familiarity with CML related concept: Philadelphia chromosome
Description
% of participants who are not (at all) familiar with the concept Philadelphia chromosome
Time Frame
at baseline
Title
Familiarity with CML related concept: Philadelphia chromosome
Description
% of participants who are not (at all) familiar with the concept Philadelphia chromosome
Time Frame
6 months after baseline
Title
Familiarity with CML related concept: BCR-ABL
Description
% of participants who are not (at all) familiar with the concept BCR-ABL
Time Frame
at baseline
Title
Familiarity with CML related concept: BCR-ABL
Description
% of participants who are not (at all) familiar with the concept BCR-ABL
Time Frame
6 months after baseline
Title
Familiarity with CML related concept: tyrosine kinase inhibitor
Description
% of participants who are not (at all) familiar with the concept tyrosine kinase inhibitor
Time Frame
at baseline
Title
Familiarity with CML related concept: tyrosine kinase inhibitor
Description
% of participants who are not (at all) familiar with the concept tyrosine kinase inhibitor
Time Frame
6 months after baseline
Title
Familiarity with CML related concept: remission
Description
% of participants who are not (at all) familiar with the concept remission
Time Frame
at baseline
Title
Familiarity with CML related concept: remission
Description
% of participants who are not (at all) familiar with the concept remission
Time Frame
6 months after baseline
Title
Familiarity with CML related concept: log reduction
Description
% of participants who are not (at all) familiar with the concept log reduction
Time Frame
at baseline
Title
Familiarity with CML related concept: log reduction
Description
% of participants who are not (at all) familiar with the concept log reduction
Time Frame
6 months after baseline
Title
Familiarity with CML related concept: hematologic response/remission
Description
% of participants who are not (at all) familiar with the concept hematologic response/remission
Time Frame
at baseline
Title
Familiarity with CML related concept: hematologic response/remission
Description
% of participants who are not (at all) familiar with the concept hematologic response/remission
Time Frame
6 months after baseline
Title
Familiarity with CML related concept: cytogenetic response/remission
Description
% of participants who are not (at all) familiar with the concept cytogenetic response/remission
Time Frame
at baseline
Title
Familiarity with CML related concept: cytogenetic response/remission
Description
% of participants who are not (at all) familiar with the concept cytogenetic response/remission
Time Frame
6 months after baseline
Title
Familiarity with CML related concept: molecular response/remission
Description
% of participants who are not (at all) familiar with the concept molecular response/remission
Time Frame
at baseline
Title
Familiarity with CML related concept: molecular response/remission
Description
% of participants who are not (at all) familiar with the concept molecular response/remission
Time Frame
6 months after baseline
Title
Familiarity with CML related concept: major molecular remission
Description
% of participants who are not (at all) familiar with the concept major molecular remission
Time Frame
at baseline
Title
Familiarity with CML related concept: major molecular remission
Description
% of participants who are not (at all) familiar with the concept major molecular remission
Time Frame
6 months after baseline
Title
Familiarity with CML related concept: complete cytogenetic remission
Description
% of participants who are not (at all) familiar with the concept complete cytogenetic remission
Time Frame
at baseline
Title
Familiarity with CML related concept: complete cytogenetic remission
Description
% of participants who are not (at all) familiar with the concept complete cytogenetic remission
Time Frame
6 months after baseline
Title
Familiarity with CML related concept: treatment free remission
Description
% of participants who are not (at all) familiar with the concept treatment free remission
Time Frame
at baseline
Title
Familiarity with CML related concept: treatment free remission
Description
% of participants who are not (at all) familiar with the concept treatment free remission
Time Frame
6 months after baseline
Title
Familiarity with CML related concept: Hematon
Description
% of participants who are not (at all) familiar with the concept hematon
Time Frame
at baseline
Title
Familiarity with CML related concept: Hematon
Description
% of participants who are not (at all) familiar with the concept hematon
Time Frame
6 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Radboudumc
City
Nijmegen
State/Province
Gelderland
ZIP/Postal Code
6525 GA
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The plan is to share IPD when Radboudumc arranged this possibility.

Learn more about this trial

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

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