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

NCT04595955 | Completed

• 1 other identifier: RU_23-08-20_LV
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Chronic Myeloid Leukemia; Patient Portals; Telemedicine

Outcome Measures

Primary Outcomes (16)

• the information received by CML patients

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

  at baseline

• the information received by CML patients

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

  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

  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

  6 months after baseline

• eHealth Literacy

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

  at baseline

• eHealth Literacy

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

  6 months after baseline

• medication compliance

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

  at baseline

• medication compliance

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

  6 months after baseline

• guideline adherence

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

  at baseline

• guideline adherence

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

  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

  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

  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

  at baseline

• Quality of life of CML patients: EORTC QLQ-C30

  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

  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

  disease specific quality of life of participants was measured using the EORTC QLQ-CML24

  6 months after baseline

Secondary Outcomes (24)

• Familiarity with CML related concept: Philadelphia chromosome

  at baseline

• Familiarity with CML related concept: Philadelphia chromosome

  6 months after baseline

• Familiarity with CML related concept: BCR-ABL

  at baseline

• Familiarity with CML related concept: BCR-ABL

  6 months after baseline

• Familiarity with CML related concept: tyrosine kinase inhibitor

  at baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

This arm uses the CMyLife platform for at least 6 months

Other: CMyLife

Control group

NO INTERVENTION

This arm does not use the CMyLife platform

Interventions

CMyLife OTHER

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

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Participants in acceleration phase
• Participants in blastcrise
• Participants with planned pregnancy in the study period

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 36890512 DERIVED

MeSH Terms

Conditions

Neoplasms; Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 22, 2020
• Study Start: July 1, 2019
• Primary Completion: August 31, 2020
• Study Completion: August 31, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-09

Locations

NL (1)