List of projects | Quality of Life in Hematology - GIMEMA

Title	Disease	Brief description
AML1025	Acute Myeloid Leukemia	The primary objective of the study is to prospectively describe health-related quality of life (HRQoL) of patients with acute myeloid leukemia (AML) treated with oral decitabine-cedazuridine (DEC).
HEMATOWELLNESS	Acute Myeloid Leukemia Multiple myeloma Lymphoma	Adherence, defined as the proportion of patients who complete the intervention; Satisfaction, determined by the proportion of participants who report being at least somewhat satisfied with the intervention.
APOLLO	Acute Promyelocytic Leukemia	Investigate possible differences in the following a priori selected scales: physical functioning, cognitive functioning as well as fatigue, nausea and vomiting, constipation and appetite loss
PROACTIVE	Acute Promyelocytic Leukemia Acute Myeloid Leukemia Myelodysplastic Syndromes	The main objective of this study is assessing the prevalence of clinically important problems and symptoms in a large cohort of patients, but another strength of the study, intrinsic in its nature is its versatility.
ALLIANCE	All Hematologic Malignancies	The GIMEMA-ALLIANCE platform was designed for the onco-hematologic setting and includes secure portals for both patients and physicians. It enables electronic Patient-Reported Outcome (ePRO) assessments, allowing physicians to view real-time
IMPROVE	Hematologic malignancies and solid tumors	The project will explore concerns and risk factors related to open-label bias through stakeholder interviews. We will also assess the magnitude of open-label bias in trials with PRO endpoints, and develop a standardized tool to evaluate the risk of open-label bias in onco-hematologic trials
CAR-T	Lymphoma	The primary objective of the study is to investigate changes over time in patient-reported fatigue of adult patients with aggressive B cell lymphoma treated with CAR-T cell therapy.
CLARITY	Multiple Myeloma	The primary objective is overall survival (OS) as predicted by baseline self-reported EORTC QLQ-C30, fatigue scale ratings, independently from other prognostic factors for OS, including the clinically-based prognostic frailty score.
Consensus icMDS	Myelodysplastic Syndromes	To develop a common PRO metric, the icMDS-PRO score, to be used consistently across MDS trials and facilitate comparison of study results
PROMYS	Myelodysplastic Syndromes	The primary objective of the study is to investigate the prognostic value of baseline patients’ reported fatigue for overall survival in newly diagnosed myelodysplastic syndrome (MDS) patients.
PROPHECY	Myeloproliferative neoplasms (MPNs)	The primary objective of the study is to compare Health-related Quality of life (HRQoL) profiles of patients with Philadelphia chromosome negative myeloproliferative neoplasm (MPN)
TRAP	Primary Immune Thrombocytopenia	The primary objective of the study is to assess adherence to thrombopoietin receptor agonists (TPO-RAs) and identify factors predicting medication-taking behavior in patients with primary immune thrombocytopenia (ITP) treated with TPO-RAs.
VEXAS	Vexas Syndrome	To describe Health-Related Quality of Life (HRQoL) and symptom profile of patients with VEXAS syndrome

Secondary Endpoint

Title	Disease	Brief description
ALL2418	Acute Lymphoblastic Leukemia	The primary objective of the QoL assessment is the description of QoL profile over time.
ALL2820	Acute Lymphoblastic Leukemia	To estimate and compare mean trajectories over time between treatment arms of the FACIT-Fatigue scale.
AML1718	Acute Myeloid Leukemia	The primary objective of the QoL assessment is the description of QoL profile over time
AML1819	Acute Myeloid Leukemia	To describe longitudinal QoL profile of AML patients from baseline to the end of consolidation therapy.
AML2924	Acute Myeloid Leukemia	To describe changes over time in HRQoL. To investigate HRQoL factors predicting clinical and survival outcomes. To assess patient-reported treatment tolerability
BOX TRAIL	Acute Myeloid Leukemia	The objective of PRO assessment is to investigate changes over time in patient-reported outcomes of adult AML patients with who are receiving targeted AML treatment after enrollment in this study.
CLL1920	Chronic Lymphocytic Leukemia	Mean Quality of Life (QoL) scores trajectories by the EORTC QLQ-C30 and QLQ-CLL17 questionnaires
CLL2323	Chronic Lymphocytic Leukemia	Quality of life and other patient reported oucomes at baseline and after 3, 6 and 12 cycles of therapy (28-day cycles)
PEARL	Chronic Myeloid Leukemia	To examine HRQoL differences (indicated by selected key HRQoL outcomes) over time (i.e. up to 24 months) between treatment arms.
SUSTRENIM	Chronic Myeloid Leukemia	To investigate quality of life (QoL) differences between treatment arms over time
ACROBAT	Myelodysplastic Syndromes	To describe and compare QoL profiles over time between patients with < 10% BM blasts randomized to either HMT followed by HSCT or HSCT upfront; and between patients with ≥ 10% BM blasts randomized to either CHT or HMT, before HSCT.