MyPal ePRO-based Early Palliative Care System in Adult Patients With Hematologic Malignancies
Randomized Clinical Trial of the MyPal ePRO-based Early Palliative Care System in Adult Patients With Hematologic Malignancies
1 other identifier
interventional
300
1 country
1
Brief Summary
Randomized unblinded interventional clinical trial: Arm Intervention Experimental arm (n=150): Intervention group Administration of the MyPal ePRO system the intervention group will use the ePRO tools provided in the project. Standard care arm (n=150): no intervention besides general palliative care if required general palliative care if required. Patients will be randomly assigned in a 1:1 fashion to use the MyPal system and receive related-intervention versus general palliative care, stratified by cancer type (i.e. CLL vs MDS), using a computer-generated number sequence, which will be concealed until after group assignment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2020
CompletedFirst Posted
Study publicly available on registry
May 1, 2020
CompletedStudy Start
First participant enrolled
January 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2022
CompletedAugust 4, 2021
July 1, 2021
1.5 years
April 25, 2020
August 3, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Improvement in EORTC Quality of Life Questionnaire (QLQ)-C30 General Questionnaire
The primary objective is to determine whether - compared to standard care - the MyPal-ADULT intervention can lead to improved QoL as evidenced by statistically significant higher scores in EORTC Quality of Life Questionnaire (QLQ)-C30 General Questionnaire
through study completion, an average of 1 year
Improvement in EuroQol (EQ)-five dimensions (5D)
The primary objective is to determine whether - compared to standard care - the MyPal-ADULT intervention can lead to improved QoL as evidenced by statistically significant higher scores in EuroQol (EQ)-five dimensions (5D).
through study completion, an average of 1 year
Study Arms (2)
Experimental arm
EXPERIMENTALAdministration of the MyPal ePRO system
Standard care arm
NO INTERVENTIONNo further intervention besides standard palliative care approach if needed
Interventions
Patients will be asked to complete self-report questionnaires at baseline, and every month for the first six months and at 12-month follow-up
Eligibility Criteria
You may qualify if:
- Adults (≥18 years)
- Diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or myelodysplastic syndrome (MDS)
- Scheduled to receive any line of treatment for CLL/SLL or MDS or who have been previously exposed to any treatment for CLL or MDS
- Able to understand and communicate in the respective language
- Users of an Internet connected device (smart phone/tablet)
You may not qualify if:
- Patients who are already participating in another experimental study
- Patients needing immediate referral for specialized palliative care
- Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or put the study outcomes at undue risk
- Patients unable to provide written informed consent
- Life expectancy \<3 months
- For CLL cohort: patients who have experienced Richter transformation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IRCCS Ospedale San Raffaele
Milan, 20132, Italy
Related Publications (3)
Chatzikonstantinou T, Vasilopoulou M, Kyrou D, Karakatsoulis G, Argyropaidas P, Besikli-Dimou S, Bonotis P, Chatzimina M, Didi J, Dimosthenous C, Garani-Papadatos T, Hoffman S, Kakalou C, Kazantzaki E, Kiefer S, Koumakis L, Ling J, Maramis C, Meyerheim M, Payne C, Papangelou C, Payne S, Pontikoglou C, Reston R, Ryblom H, Sander A, Schera F, Smedby KE, Zacharioudakis G, Chatzidimitriou A, Doubek M, Stavroyianni N, Ghia P, Papadaki HA, Rosenquist R, Graf N, Natsiavas P, Stamatopoulos K, Karamanidou C, Scarfo L. Assessing an eHealth Intervention on Quality of Life in Patients With Chronic Lymphocytic Leukemia and Myelodysplastic Syndromes: The MyPal Randomized Controlled Trial. JCO Oncol Pract. 2025 Aug 25:OP2500087. doi: 10.1200/OP-25-00087. Online ahead of print.
PMID: 40854168DERIVEDPayne S, Begovic D, Salifu Y, Nelson A, Payne C, Downing J, Natsiavas P, Ling J. Applying Digital Health in Cancer and Palliative Care in Europe: Policy Recommendations from an International Expert Workshop (MyPal Project). J Palliat Med. 2024 Feb;27(2):216-223. doi: 10.1089/jpm.2023.0309. Epub 2023 Sep 22.
PMID: 37738323DERIVEDScarfo L, Karamanidou C, Doubek M, Garani-Papadatos T, Didi J, Pontikoglou C, Ling J, Payne C, Papadaki HAlpha, Rosenquist R, Stavroyianni N, Payne S, Ghia P, Natsiavas P, Maramis C, Stamatopoulos K. MyPal ADULT study protocol: a randomised clinical trial of the MyPal ePRO-based early palliative care system in adult patients with haematological malignancies. BMJ Open. 2021 Nov 2;11(11):e050256. doi: 10.1136/bmjopen-2021-050256.
PMID: 34728446DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paolo Ghia, MD,PhD
IRCCS San Raffaele
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2020
First Posted
May 1, 2020
Study Start
January 1, 2021
Primary Completion
June 30, 2022
Study Completion
September 30, 2022
Last Updated
August 4, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share