MyPal ePRO-based Early Palliative Care System in Adult Patients With Hematologic Malignancies
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|ClinicalTrials.gov Identifier: NCT04370457|
Recruitment Status : Recruiting
First Posted : May 1, 2020
Last Update Posted : February 3, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Myelodysplastic Syndromes||Other: Administration of the MyPal ePRO system||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Randomized Clinical Trial of the MyPal ePRO-based Early Palliative Care System in Adult Patients With Hematologic Malignancies|
|Actual Study Start Date :||December 1, 2020|
|Estimated Primary Completion Date :||March 31, 2021|
|Estimated Study Completion Date :||September 30, 2021|
Experimental: Experimental arm
Administration of the MyPal ePRO system
Other: Administration of the MyPal ePRO system
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
No Intervention: Standard care arm
No further intervention besides standard palliative care approach if needed
- Improvement in EORTC Quality of Life Questionnaire (QLQ)-C30 General Questionnaire [ Time Frame: through study completion, an average of 1 year ]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
- Improvement in EuroQol (EQ)-five dimensions (5D) [ Time Frame: through study completion, an average of 1 year ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04370457
|Contact: Paolo Ghia, Prof.||00390226433919 ext email@example.com|
|Contact: Eloise Scarano, Dr||00390226433919 ext firstname.lastname@example.org|
|Principal Investigator:||Paolo Ghia, MD,PhD||IRCCS Ospedale San Raffaele, Milan, Italy|