Hematologic Malignancies
Conditions
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.
Interventions
OTHERQuality of life assessment
Quality of life questionnaires
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
| 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 |
| 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 |
| 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 |
Countries
Italy
Contacts
Primary ContactFabio Efficace
Outcome results
None listed