NeoplasmsNCT04595955
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
A study testing CMyLife in people with Neoplasms and Chronic Myeloid Leukemia, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms, Chronic Myeloid Leukemia, Patient Portals
- What is being tested?
- CMyLife
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2019to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants in acceleration phase
- Participants in blastcrise
- Participants with planned pregnancy in the study period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Neoplasms, Chronic Myeloid Leukemia, Patient Portals, Telemedicine
- Being tested
- CMyLife
- Medical subject headings
- Neoplasms, Leukemia, Myelogenous, Chronic, BCR-ABL Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMyLifeOther
CMyLife is a digital patient platform for Patients With Chronic Myeloid Leukemia.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This arm uses the CMyLife platform for at least 6 months Receives: Other: CMyLife |
| Control group | No intervention | This arm does not use the CMyLife platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
the information received by CML patients
To evaluate the information received by participants the EORTC QLQ-INFO25 was used
Measured: at baseline
the information received by CML patients
To evaluate the information received by participants the EORTC QLQ-INFO25 was used
Measured: 6 months after baseline
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
Measured: at baseline
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
Measured: 6 months after baseline
eHealth Literacy
Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale
Measured: at baseline
eHealth Literacy
Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale
Measured: 6 months after baseline
medication compliance
medication compliance of participants was measured using the Medication Adherence Rating Scale
Measured: at baseline
medication compliance
medication compliance of participants was measured using the Medication Adherence Rating Scale
Measured: 6 months after baseline
guideline adherence
guideline adherence was measured using the frequency of BCR-ABL1 value checks
Measured: at baseline
guideline adherence
guideline adherence was measured using the frequency of BCR-ABL1 value checks
Measured: 6 months after baseline
Patients' experiences
Participants' experiences with the care and information they receive in hospitals for their CML were measured using Patient Reported Experience Measures
Measured: at baseline
Patients' experiences
Participants' experiences with the care and information they receive in hospitals for their CML were measured using Patient Reported Experience Measures
Measured: 6 months after baseline
Quality of life of CML patients: EORTC QLQ-C30
Quality of life of participants was measured using the EORTC QLQ-C30
Measured: at baseline
Quality of life of CML patients: EORTC QLQ-C30
Quality of life of participants was measured using the EORTC QLQ-C30
Measured: 6 months after baseline
disease (CML) specific quality of life: EORTC QLQ-CML24
disease specific quality of life of participants was measured using the EORTC QLQ-CML24
Measured: at baseline
disease (CML) specific quality of life: EORTC QLQ-CML24
disease specific quality of life of participants was measured using the EORTC QLQ-CML24
Measured: 6 months after baseline
Secondary outcomes (24)
Familiarity with CML related concept: Philadelphia chromosome
% of participants who are not (at all) familiar with the concept Philadelphia chromosome
Measured: at baseline
Familiarity with CML related concept: Philadelphia chromosome
% of participants who are not (at all) familiar with the concept Philadelphia chromosome
Measured: 6 months after baseline
Familiarity with CML related concept: BCR-ABL
% of participants who are not (at all) familiar with the concept BCR-ABL
Measured: at baseline
Familiarity with CML related concept: BCR-ABL
% of participants who are not (at all) familiar with the concept BCR-ABL
Measured: 6 months after baseline
Familiarity with CML related concept: tyrosine kinase inhibitor
% of participants who are not (at all) familiar with the concept tyrosine kinase inhibitor
Measured: at baseline
Familiarity with CML related concept: tyrosine kinase inhibitor
% of participants who are not (at all) familiar with the concept tyrosine kinase inhibitor
Measured: 6 months after baseline
Familiarity with CML related concept: remission
% of participants who are not (at all) familiar with the concept remission
Measured: at baseline
Familiarity with CML related concept: remission
% of participants who are not (at all) familiar with the concept remission
Measured: 6 months after baseline
Familiarity with CML related concept: log reduction
% of participants who are not (at all) familiar with the concept log reduction
Measured: at baseline
Familiarity with CML related concept: log reduction
% of participants who are not (at all) familiar with the concept log reduction
Measured: 6 months after baseline
Familiarity with CML related concept: hematologic response/remission
% of participants who are not (at all) familiar with the concept hematologic response/remission
Measured: at baseline
Familiarity with CML related concept: hematologic response/remission
% of participants who are not (at all) familiar with the concept hematologic response/remission
Measured: 6 months after baseline
Familiarity with CML related concept: cytogenetic response/remission
% of participants who are not (at all) familiar with the concept cytogenetic response/remission
Measured: at baseline
Familiarity with CML related concept: cytogenetic response/remission
% of participants who are not (at all) familiar with the concept cytogenetic response/remission
Measured: 6 months after baseline
Familiarity with CML related concept: molecular response/remission
% of participants who are not (at all) familiar with the concept molecular response/remission
Measured: at baseline
Familiarity with CML related concept: molecular response/remission
% of participants who are not (at all) familiar with the concept molecular response/remission
Measured: 6 months after baseline
Familiarity with CML related concept: major molecular remission
% of participants who are not (at all) familiar with the concept major molecular remission
Measured: at baseline
Familiarity with CML related concept: major molecular remission
% of participants who are not (at all) familiar with the concept major molecular remission
Measured: 6 months after baseline
Familiarity with CML related concept: complete cytogenetic remission
% of participants who are not (at all) familiar with the concept complete cytogenetic remission
Measured: at baseline
Familiarity with CML related concept: complete cytogenetic remission
% of participants who are not (at all) familiar with the concept complete cytogenetic remission
Measured: 6 months after baseline
Familiarity with CML related concept: treatment free remission
% of participants who are not (at all) familiar with the concept treatment free remission
Measured: at baseline
Familiarity with CML related concept: treatment free remission
% of participants who are not (at all) familiar with the concept treatment free remission
Measured: 6 months after baseline
Familiarity with CML related concept: Hematon
% of participants who are not (at all) familiar with the concept hematon
Measured: at baseline
Familiarity with CML related concept: Hematon
% of participants who are not (at all) familiar with the concept hematon
Measured: 6 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Jul 2019
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595955
- Sponsor's protocol ID
- RU_23-08-20_LV
- Status last verified
- Sep 2020
- First submitted
- 8 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan is to share IPD when Radboudumc arranged this possibility.
Publications
Verweij L, Ector GICG, Smit Y, van Vlijmen B, van der Reijden BA, Hermens RPMG, Blijlevens NMA. Effectiveness of digital care platform CMyLife for patients with chronic myeloid leukemia: results of a patient-preference trial. BMC Health Serv Res. 2023 Mar 8;23(1):228. doi: 10.1186/s12913-023-09153-9.
PubMed 36890512
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Digital Patient Platform CMyLife for Patients With Chronic Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04595955
- Acronym / sponsor ID
- RU_23-08-20_LV
- Conditions
- Neoplasms, Chronic Myeloid Leukemia, Patient Portals, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 22 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: CMyLifeThis arm uses the CMyLife platform for at least 6 months |
| Control group | No intervention | –This arm does not use the CMyLife platform |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Participants in acceleration phase
- Participants in blastcrise
- Participants with planned pregnancy in the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMyLifeCMyLife is a digital patient platform for Patients With Chronic Myeloid Leukemia. | Other | Intervention group |
Primary outcome
the information received by CML patients
Time frame: at baseline
To evaluate the information received by participants the EORTC QLQ-INFO25 was used
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
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
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
eHealth Literacy
Time frame: at baseline
Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale
eHealth Literacy
Time frame: 6 months after baseline
Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale
medication compliance
Time frame: at baseline
medication compliance of participants was measured using the Medication Adherence Rating Scale
medication compliance
Time frame: 6 months after baseline
medication compliance of participants was measured using the Medication Adherence Rating Scale
guideline adherence
Time frame: at baseline
guideline adherence was measured using the frequency of BCR-ABL1 value checks
guideline adherence
Time frame: 6 months after baseline
guideline adherence was measured using the frequency of BCR-ABL1 value checks
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
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
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
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
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
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
24 secondary outcomes
Familiarity with CML related concept: Philadelphia chromosome
Time frame: at baseline
Familiarity with CML related concept: Philadelphia chromosome
Time frame: 6 months after baseline
Familiarity with CML related concept: BCR-ABL
Time frame: at baseline
Familiarity with CML related concept: BCR-ABL
Time frame: 6 months after baseline
Familiarity with CML related concept: tyrosine kinase inhibitor
Time frame: at baseline
Familiarity with CML related concept: tyrosine kinase inhibitor
Time frame: 6 months after baseline
Familiarity with CML related concept: remission
Time frame: at baseline
Familiarity with CML related concept: remission
Time frame: 6 months after baseline
Familiarity with CML related concept: log reduction
Time frame: at baseline
Familiarity with CML related concept: log reduction
Time frame: 6 months after baseline
Familiarity with CML related concept: hematologic response/remission
Time frame: at baseline
Familiarity with CML related concept: hematologic response/remission
Time frame: 6 months after baseline
Familiarity with CML related concept: cytogenetic response/remission
Time frame: at baseline
Familiarity with CML related concept: cytogenetic response/remission
Time frame: 6 months after baseline
Familiarity with CML related concept: molecular response/remission
Time frame: at baseline
Familiarity with CML related concept: molecular response/remission
Time frame: 6 months after baseline
Familiarity with CML related concept: major molecular remission
Time frame: at baseline
Familiarity with CML related concept: major molecular remission
Time frame: 6 months after baseline
Familiarity with CML related concept: complete cytogenetic remission
Time frame: at baseline
Familiarity with CML related concept: complete cytogenetic remission
Time frame: 6 months after baseline
Familiarity with CML related concept: treatment free remission
Time frame: at baseline
Familiarity with CML related concept: treatment free remission
Time frame: 6 months after baseline
Familiarity with CML related concept: Hematon
Time frame: at baseline
Familiarity with CML related concept: Hematon
Time frame: 6 months after baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Derived from this study: PubMed 36890512Verweij L, Ector GICG, Smit Y, van Vlijmen B, van der Reijden BA, Hermens RPMG, Blijlevens NMA. Effectiveness of digital care platform CMyLife for patients with chronic myeloid leukemia: results of a patient-preference trial. BMC Health Serv Res. 2023 Mar 8;23(1):228. doi: 10.1186/s12913-023-09153-9.
- Individual participant dataSharing planned: Undecided. The plan is to share IPD when Radboudumc arranged this possibility.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMyLife in people with Neoplasms and Chronic Myeloid Leukemia, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the information received by CML patients (time frame: at baseline). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04595955, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.