Long-term Outcomes for Acute Myeloid Leukemia Patients
- Conditions
- Acute Myeloid Leukemia
- Registration Number
- NCT03755856
- Brief Summary
This international observational study aims at examining the patterns of health-related quality of life differences between long-term acute myeloid leukemia patients and their healthy peers from the general population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 343
- Diagnosis of all subtypes of de novo AML, according to WHO criteria (at least 20% blasts in the bone marrow), except acute promyelocytic leukemia (APL).
- Age at AML diagnosis ≥ 18 years,
- Date of AML diagnosis at least 5 years before study enrollment,
- AML-free status at study enrollment,
- Written informed consent provided.
- Major cognitive deficit or psychiatric problems hampering a self-reported evaluation,
- Not speaking and reading the language of the participating country,
- More than 75 years at the time of study enrollment,
- Receiving any active treatment for AML at the time of study enrollment.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of differences in SF-36 scores At enrollment The Role Physical scores of AML survivors will be compared to that in the general population as assessed by SF-36 questionnaire. Comparisons will be performed on age-sex matched pairs of AML patients and healthy subjects from the general population.
- Secondary Outcome Measures
Name Time Method Outcomes from SF-36 questionnaire will be described and compared between AML patients from RCTs vs non RCTs. At enrollment Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores
Outcomes from SCQ questionnaire will be described and compared between AML patients from RCTs vs non RCTs. At enrollment Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores.
Outcomes from EORTC QLQ-C30 questionnaire will be described and compared between AML patients from RCTs vs non RCTs. At enrollment Prior to these comparisons, to further minimize the possible influence of confounding factors, RCTs and non RCTs AML groups will be previously matched on their estimated propensity scores.
QoL profiles of AML survivors will be compared with those in the general population also as assessed by EORTC QLQ-C30 questionnaire. At enrollment Comparisons will be adjusted by age and sex, using the European reference values for the EORTC QLQ-C30. A subgroup analysis on elderly patients (i.e. 60+ patients) will be also performed.
Trial Locations
- Locations (39)
UZ Gasthuisberg
🇧🇪Leuven, Belgium
CHR Citadelle-CHU
🇧🇪Liège, Belgium
UKC Ljubljana
🇸🇮Ljubljana, Slovenia
Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI
🇮🇹Ancona, Italy
U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari
🇮🇹Bari, Italy
Divisione di Ematologia Ospedale A. Perrino
🇮🇹Brindisi, Italy
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
🇮🇹Foggia, Italy
IRCCS_AOU San Martino-IST.Clinica Ematologica
🇮🇹Genova, Italy
KBC Rijeka
🇭🇷Rijeka, Croatia
University of Liège
🇧🇪Liège, Belgium
Les Hôpitaux Universitaires de Strasbourg
🇫🇷Lyon, France
UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"
🇮🇹Barletta, Italy
University Hospital Centre Zagreb
🇭🇷Zagreb, Croatia
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
🇮🇹Cagliari, Italy
Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto
🇮🇹Catania, Italy
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
🇮🇹Cona, Italy
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
🇮🇹Novara, Italy
Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano
🇮🇹Milano, Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
🇮🇹Napoli, Italy
UOC di Ematologia-Centro Emofilia e Trombosi - Ospedale Ascalesi - ASL Napoli 1
🇮🇹Napoli, Italy
Orbassano Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2
🇮🇹Orbassano, Italy
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
🇮🇹Padova, Italy
U.O. Ematologia e CTMO- AOU di Parma
🇮🇹Parma, Italy
U.O. di Ematologia con trapianto - A.U. Policlinico "Paolo Giaccone"
🇮🇹Palermo, Italy
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto
🇮🇹Piacenza, Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
🇮🇹Reggio Emilia, Italy
Ematologia - Ospedale San Carlo
🇮🇹Potenza, Italy
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
🇮🇹Roma, Italy
Divisione di Ematologia - Ospedale S.Eugenio
🇮🇹Roma, Italy
Roma Divisione Ematologia - Università Campus Bio-Medico
🇮🇹Roma, Italy
Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)
🇮🇹Roma, Italy
Università degli Studi "Sapienza" - Dip Medicina di Precisione e Ricerca Traslazionale UOC Ematologia
🇮🇹Roma, Italy
Istituto di Semeiotica Medica - Ematologia - Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
🇮🇹Roma, Italy
U.O. di Ematologia - Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Italy
Ematologia - AOU Sassari
🇮🇹Sassari, Italy
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
University Clinic of Hematology-Skopje
🇲🇰Skopje, North Macedonia
University hospital Bratislava
🇸🇰Bratislava, Slovakia
Ankara University School Of Medicine Cebeci Campus Adult Hematology Department and BMT Unit
🇹🇷Ankara, Turkey