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

Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto (Other)
Overall Status
Recruiting
CT.gov ID
NCT04581187
Collaborator
(none)
400
Enrollment
27
Locations
48
Anticipated Duration (Months)
14.8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Other: Quality of life assessment

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
400 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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 :
Dec 2, 2020
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2024

Outcome Measures

Primary Outcome Measures

  1. HRQOL in adult patients with hematologic malignancies [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 [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 [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 [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona Ancona Italy
2 Irccs Centro Di Riferimento Oncologico Di Aviano - Sosd Oncoematologia Trapianti Emopoietici E Terapie Cellulari Aviano Italy
3 Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto Bari Italy
4 Irccs Oncologico Istituto Tumori Giovanni Paolo II - UO Ematologia Bari Italy
5 Asl Della Provincia Di Barletta, Andria, Trani, Ospedale "Mons. Dimiccoli" - UOC Ematologia Barletta Italy
6 AO Brotzu, Presidio Ospedaliero A. Businco - Cagliari - SC Ematologia E CTMO Cagliari Italy
7 Aou Policlinico Vittorio Emanuele, Presidio Ospedaliero Ferrarotto -Divisione Clinicizzata Di Ematologia Catania Italy
8 Aou Ospedali Riuniti - Foggia- UOC Ematologia Foggia Italy
9 Asl Lecce, Ospedale 'V. Fazzi' - Uo Ematologia Lecce Italy
10 Aou Di Modena- Sc Ematologia- Dipartimento Di Oncologia Ed Ematologia Modena Italy
11 Ao Di Rilievo Nazionale Antonio Cardarelli - UOC Ematologia Napoli Italy
12 S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Aou Maggiore Della Carità Di Novara Novara Italy
13 Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo Palermo Italy
14 Aou Policlinico P. Giaccone - Uo Ematologia Dipartimento Biomedico Di Medicina Interna E Specialistica Palermo Italy
15 Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica Pescara Italy
16 Ausl Reggio Emilia, Presidio Ospedaliero "Arcispedale Santa Maria Nuova" - Irccs- Uo Ematologia Reggio Emilia Italy
17 Ao San Camillo Forlanini - Uoc Ematologia E Trapianto Cellule Staminali Roma Italy
18 AOU Policlinico Tor Vergata - UOC Trapianto Cellule Staminali Roma Italy
19 Aou Policlinico Umberto I - Dipartimento Di Medicina Traslazionale - Sezione Ematologia Roma Italy
20 Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia Roma Italy
21 Divisione di Ematologia - Ospedale S. Eugenio Roma Italy
22 Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali Roma Italy
23 Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia San Giovanni Rotondo Italy
24 Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia Sassari Italy
25 Ospedale Di Sassuolo Spa - Ematologia Sassuolo Italy
26 Asl To 2, Torino Nord Emergenza San Giovanni Bosco - Ssd Ematologia Torino Italy
27 Torino Dipartimento di Oncologia ed Ematologia S.C. Ematologia 2 A.O. Città della Salute e della Scienza di Torino San Giovanni Battista Torino Italy

Sponsors and Collaborators

  • Gruppo Italiano Malattie EMatologiche dell'Adulto

Investigators

  • Principal Investigator: Marco Vignetti, GIMEMA Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT04581187
Other Study ID Numbers:
  • GIMEMA-ALLIANCE Platform
First Posted:
Oct 9, 2020
Last Update Posted:
May 17, 2021
Last Verified:
May 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
COVID-19
Neoplasms
Hematologic Neoplasms

Study Results

No Results Posted as of May 17, 2021