Status:
UNKNOWN
MyPal ePRO-based Early Palliative Care System in Adult Patients With Hematologic Malignancies
Lead Sponsor:
Centre for Research and Technology Hellas
Conditions:
Chronic Lymphocytic Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
Phase:
NA
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 tool...
Detailed Description
The MyPal eHealth system coincides with the MyPal intervention. The system will be used primarily by the patients that participate in the intervention arm of the trial and secondarily by the participa...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT04370457
Start Date
January 1 2021
End Date
September 30 2022
Last Update
August 4 2021
Active Locations (1)
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1
IRCCS Ospedale San Raffaele
Milan, Italy, 20132