An Online-platform to Improve Patient-centered Care During the COVID-19 Pandemic: a GIMEMA Surveillance Program in Hematologic Malignancies

May 13, 2021 updated by: Gruppo Italiano Malattie EMatologiche dell'Adulto

An onLine-pLatform to Improve Patient-centered Care During the COVID-19 pAndemic: a GIMEMA surveillaNce Program in hematologiC malignanciEs

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Ancona, Italy
        • Not yet recruiting
        • Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona
      • Aviano, Italy
        • Not yet recruiting
        • Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari
      • Bari, Italy
        • Not yet recruiting
        • Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
      • Bari, Italy
        • Recruiting
        • Irccs Oncologico Istituto Tumori Giovanni Paolo II - UO Ematologia
      • Barletta, Italy
        • Not yet recruiting
        • Asl Della Provincia Di Barletta, Andria, Trani, Ospedale "Mons. Dimiccoli" - UOC Ematologia
      • Cagliari, Italy
        • Recruiting
        • Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
      • Catania, Italy
        • Not yet recruiting
        • Aou Policlinico Vittorio Emanuele, Presidio Ospedaliero Ferrarotto -Divisione Clinicizzata Di Ematologia
      • Foggia, Italy
        • Recruiting
        • Aou Ospedali Riuniti - Foggia- UOC Ematologia
      • Lecce, Italy
        • Recruiting
        • Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia
      • Modena, Italy
        • Recruiting
        • Aou Di Modena- Sc Ematologia- Dipartimento Di Oncologia Ed Ematologia
      • Napoli, Italy
        • Recruiting
        • Ao Di Rilievo Nazionale Antonio Cardarelli - UOC Ematologia
      • Novara, Italy
        • Recruiting
        • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Aou Maggiore Della Carità Di Novara
      • Palermo, Italy
        • Recruiting
        • Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
      • Palermo, Italy
        • Recruiting
        • Aou Policlinico P. Giaccone - Uo Ematologia Dipartimento Biomedico Di Medicina Interna E Specialistica
      • Pescara, Italy
        • Not yet recruiting
        • Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
      • Reggio Emilia, Italy
        • Recruiting
        • Ausl Reggio Emilia, Presidio Ospedaliero "Arcispedale Santa Maria Nuova" - Irccs- Uo Ematologia
      • Roma, Italy
        • Recruiting
        • Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
      • Roma, Italy
        • Recruiting
        • Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
      • Roma, Italy
        • Recruiting
        • Ao San Camillo Forlanini - Uoc Ematologia E Trapianto Cellule Staminali
      • Roma, Italy
        • Not yet recruiting
        • AOU Policlinico Tor Vergata - UOC Trapianto Cellule Staminali
      • Roma, Italy
        • Recruiting
        • Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia
      • Roma, Italy
        • Recruiting
        • Divisione di Ematologia - Ospedale S. Eugenio
      • San Giovanni Rotondo, Italy
        • Recruiting
        • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
      • Sassari, Italy
        • Recruiting
        • Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
      • Sassuolo, Italy
        • Not yet recruiting
        • Ospedale Di Sassuolo Spa - Ematologia
      • Torino, Italy
        • Recruiting
        • Asl To 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia
      • Torino, Italy
        • Not yet recruiting
        • Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients diagnosed with any hematologic malignancy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
After 2 years from date of registration
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)
After 2 years from date of registration
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)
After 2 years from date of registration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
After 2 years from date of registration
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
After 2 years from date of registration
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
After 2 years from date of registration
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
After 2 years from date of registration
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
After 2 years from date of registration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Marco Vignetti, GIMEMA Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2020

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

September 30, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (Actual)

October 9, 2020

Study Record Updates

Last Update Posted (Actual)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIMEMA-ALLIANCE Platform

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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