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MyPal ePRO-based Early Palliative Care System in Adult Patients With Hematologic Malignancies

NCT04370457 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-08-04

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Centre for Research and Technology Hellas

    lead OTHER

Principal Investigators

  • Paolo Ghia, MD,PhD · IRCCS San Raffaele

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2022-06-30
Completion
2022-09-30

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04370457 on ClinicalTrials.gov