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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04370457
Recruitment Status : Not yet recruiting
First Posted : May 1, 2020
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
Centre for Research and Technology Hellas

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.


Condition or disease Intervention/treatment Phase
Chronic Lymphocytic Leukemia Myelodysplastic Syndromes Other: Administration of the MyPal ePRO system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
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
Estimated Study Start Date : May 1, 2020
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : September 30, 2021


Arm Intervention/treatment
Experimental: Experimental arm 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



Primary Outcome Measures :
  1. 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

  2. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Paolo Ghia, Prof. 00390226433919 ext 3919 ghia.paolo@hsr.it
Contact: Eloise Scarano, Dr 00390226433919 ext 3919 scarano.eloise@hsr.it

Sponsors and Collaborators
Centre for Research and Technology Hellas

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Responsible Party: Centre for Research and Technology Hellas
ClinicalTrials.gov Identifier: NCT04370457    
Other Study ID Numbers: MyPAL4Adults
First Posted: May 1, 2020    Key Record Dates
Last Update Posted: May 1, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia, Lymphocytic, Chronic, B-Cell
Hematologic Neoplasms
Myelodysplastic Syndromes
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Leukemia, Lymphoid
Leukemia
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Neoplasms by Site