Clinical trial · Interventional
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
NCT04370457CI-TRIAL-00053065unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia | Chronic Lymphocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Administration of the MyPal ePRO system | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- Administration of the MyPal ePRO system
- interventionNames
- Other: Administration of the MyPal ePRO system
- type
- NO_INTERVENTION
- label
- Standard care arm
- description
- No further intervention besides standard palliative care approach if needed
Primary outcomes (2)
- measure
- Improvement in EORTC Quality of Life Questionnaire (QLQ)-C30 General Questionnaire
- timeFrame
- through study completion, an average of 1 year
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Adults (≥18 years) 2. Diagnosed with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) or myelodysplastic syndrome (MDS) 3. 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 4. Able to understand and communicate in the respective language 5. Users of an Internet connected device (smart phone/tablet) Exclusion Criteria: 1. Patients who are already participating in another experimental study 2. Patients needing immediate referral for specialized palliative care 3. 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 4. Patients unable to provide written informed consent 5. Life expectancy \<3 months 6. For CLL cohort: patients who have experienced Richter transformation
References
Publications (4)
- DERIVEDChatzikonstantinou 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. 2026 Jul;22(7):1227-1237. doi: 10.1200/OP-25-00087. Epub 2025 Aug 25. PMID 40854168
- DERIVEDBonotis P, Angelidis P, Natsiavas P. Usability and User Experience Testing of a Co-Designed Electronic Patient-Reported Outcomes App ("MyPal for Adults") for Palliative Cancer Care: Mixed Methods Study. JMIR Hum Factors. 2025 Apr 24;12:e57342. doi: 10.2196/57342. PMID 40278640
- DERIVEDPayne 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 37738323
- DERIVEDScarfo 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 34728446