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OpenTrials
Completed

NCT Number: 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

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.

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Key information

Conditions

Neoplasms Bone Marrow Diseases Chronic Disease Chronic Myeloid Leukemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid Myeloproliferative Disorders Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Portals Telemedicine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CMyLife

Other

CMyLife is a digital patient platform for Patients With Chronic Myeloid Leukemia.

Primary outcomes

  1. the information received by CML patients

    Time frame: at baseline

    To evaluate the information received by participants the EORTC QLQ-INFO25 was used

  2. 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

  3. 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

  4. 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

  5. eHealth Literacy

    Time frame: at baseline

    Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale

  6. eHealth Literacy

    Time frame: 6 months after baseline

    Participants' ability to find and evaluate online health information was measured using the eHealth Literacy Scale

  7. medication compliance

    Time frame: at baseline

    medication compliance of participants was measured using the Medication Adherence Rating Scale

  8. medication compliance

    Time frame: 6 months after baseline

    medication compliance of participants was measured using the Medication Adherence Rating Scale

  9. guideline adherence

    Time frame: at baseline

    guideline adherence was measured using the frequency of BCR-ABL1 value checks

  10. guideline adherence

    Time frame: 6 months after baseline

    guideline adherence was measured using the frequency of BCR-ABL1 value checks

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

Secondary outcomes

  1. Familiarity with CML related concept: Philadelphia chromosome

    Time frame: at baseline

    % of participants who are not (at all) familiar with the concept Philadelphia chromosome

  2. 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

  3. Familiarity with CML related concept: BCR-ABL

    Time frame: at baseline

    % of participants who are not (at all) familiar with the concept BCR-ABL

  4. 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

  5. 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

  6. 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

  7. Familiarity with CML related concept: remission

    Time frame: at baseline

    % of participants who are not (at all) familiar with the concept remission

  8. Familiarity with CML related concept: remission

    Time frame: 6 months after baseline

    % of participants who are not (at all) familiar with the concept remission

  9. Familiarity with CML related concept: log reduction

    Time frame: at baseline

    % of participants who are not (at all) familiar with the concept log reduction

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. Familiarity with CML related concept: Hematon

    Time frame: at baseline

    % of participants who are not (at all) familiar with the concept hematon

  24. Familiarity with CML related concept: Hematon

    Time frame: 6 months after baseline

    % of participants who are not (at all) familiar with the concept hematon

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Effectiveness of the Digital Patient Platform CMyLife for Patients With Chronic Myeloid Leukemia

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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