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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hematologic Malignancies

Intervention / Treatment
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* Other: Quality of life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Quality of life assessment|Quality of life questionnaires|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HRQOL in adult patients with hematologic malignancies | 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 | 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 | 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 | 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 | 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 | 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 | 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 | To describe clinical strategies adopted by physicians in response to patient-generated alerts, across different clinical scenarios | After 2 years from date of registration |