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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 2, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 9, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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