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An Online-platform to Improve Patient-centered Care During the COVID-19 Pandemic: a GIMEMA Surveillance Program in 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: NCT04581187
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Study Description
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Brief Summary:
This is a national multicenter prospective observational study led by the GIMEMA. The GIMEMA-ALLIANCE Platform is also an online monitoring system for patients with hematologic malignancies aiming at helping hematologists in the early recognition and timely management of problems of their patients. Based on patient's rating of specific items (i.e. on the presence of clinically relevant problems or problems with adherence to therapy or risk of SARS-CoV-2 infection), the Platform will automatically send alerts to the treating hematologist (and/or appointed members of the local Team). Physicians will be free to make any action they feel appropriate for the best care of their patients.

Condition or disease Intervention/treatment
Hematologic Malignancies Other: Quality of life assessment

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: An onLine-pLatform to Improve Patient-centered Care During the COVID-19 pAndemic: a GIMEMA surveillaNce Program in hematologiC malignanciEs
Actual Study Start Date : December 2, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Quality of life assessment
    Quality of life questionnaires

Outcome Measures
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Primary Outcome Measures :
  1. HRQOL in adult patients with hematologic malignancies [ Time Frame: After 2 years from date of registration ]
    To prospectively assess HRQOL in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)

  2. Symptoms in adult patients with hematologic malignancies [ Time Frame: After 2 years from date of registration ]
    To prospectively assess symptoms in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)

  3. Adherence to therapy in adult patients with hematologic malignancies [ Time Frame: After 2 years from date of registration ]
    To prospectively assess adherence to therapy in adult patients with hematologic malignancies, overall and by patient subgroups (e.g., by diagnosis of COVID-19)


Secondary Outcome Measures :
  1. Prevalence of clinically relevant functional limitations and symptoms [ Time Frame: After 2 years from date of registration ]
    To describe the prevalence of clinically relevant functional limitations (e.g., physical and social) and symptoms (e.g., fatigue, pain and dyspnea) by type of hematologic malignancy and by type of treatment (e.g., standard chemotherapy of oral anticancer therapies)

  2. Factors associated with physical and mental health concerns, as measured by EORTC QLQ-C30 questionnaire [ Time Frame: After 2 years from date of registration ]
    To investigate factors associated with physical and mental health concerns

  3. Financial and social impact imposed by the COVID-19 pandemic on patient health outcomes [ Time Frame: After 2 years from date of registration ]
    To examine the financial and social impact imposed by the COVID-19 pandemic on patient health outcomes

  4. Limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes [ Time Frame: After 2 years from date of registration ]
    To examine the limitations in accessing routine medical care services imposed by the COVID-19 pandemic on patient health outcomes

  5. Clinical strategies adopted by physicians [ Time Frame: After 2 years from date of registration ]
    To describe clinical strategies adopted by physicians in response to patient-generated alerts, across different clinical scenarios


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients diagnosed with any hematologic malignancy
Criteria

Inclusion Criteria:

  • Diagnosis of any hematologic malignancy according to 2016 WHO classification
  • Adult Patients (≥18 years).
  • Written informed consent

Exclusion Criteria:

  • Major cognitive deficits or psychiatric problems hampering a self-reported evaluation.
  • Not able to read and understand local language
Contacts and Locations
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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): NCT04581187


Contacts
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Contact: Fabio Efficace +39 06441639831 alliance@gimema.it

Locations
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Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
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Principal Investigator: Marco Vignetti GIMEMA Foundation
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT04581187    
Other Study ID Numbers: GIMEMA-ALLIANCE Platform
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 2021

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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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COVID-19
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Respiratory Tract Infections
Infections
Pneumonia, Viral
 Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases