This is a prospective and international observational study run by the GIMEMA. All data will be centrally collected and analyzed at the GIMEMA Data Center in Rome (Italy). Patients reported outcomes will be collected using internationally validated questionnaires.
Study Type
OBSERVATIONAL
Enrollment
161
Quality of life questionnaires
UOC Ematologia e Terapia Cellulare - Ospedale C. e G. Mazzoni di Ascoli Piceno
Ascoli Piceno, Italy
Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia
To examine cross-sectional long-term differences in health outcomes after treatment end.
Indicated by selected key-QoL outcomes (i.e. Fatigue, Cognitive and Role functioning scales from the EORTC-QLQ-C30 questionnaire), between APL patients treated with ATRA plus chemotherapy versus patients treated with ATRA plus ATO.
Time frame: Two years after study entry.
To examine long-term differences in health outcomes after treatment end indicated by all QoL outcomes not considered in primary objectives, between APL patients treated with ATRA plus chemotherapy versus patients treated with ATRA plus ATO.
(including the functional status and symptomatology).
Time frame: Two years after study entry.
To investigate clinical, laboratory, socio-demographic and QoL factors predicting long-term health/QoL outcomes of APL patients after treatment end.
(as reported at 3rd consolidation).
Time frame: Two years after study entry.
To compare the long-term QoL profile, after treatment end, of APL patients treated with ATRA- chemotherapy and ATRA-ATO with that of their peers in the general population.
Compared with the general population (without cancer).
Time frame: Two years after study entry.
To assess and compare the cumulative incidence and types of physician-reported late adverse effects (e.g. cardiac function) and secondary cancer, between randomized treatment groups.
(ATRA plus chemotherapy versus ATRA plus ATO).
Time frame: Two years after study entry.
To assess and compare the prevalence of long-term patient-reported comorbidities and symptoms, after treatment end, between randomized treatment groups.
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Brescia, Italy
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze MEdiche Sezione di Ematologia e Fisiopatologia dell'Emostasi
Cona, Italy
AOU - Policlinico G. Martino Messina Medicine Specialistiche e Oncologia Medica - UOC Ematologia
Messina, Italy
Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico
Milan, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia - Padiglione Marcora 2do piano
Milan, Italy
UO Ematologia e Trapiano di Midollo - Ist. Scientifico Ospedale San Raffaele
Milan, Italy
UO Ematologia - AOU Policlinico di Modena
Modena, Italy
SCDU Medicina Interna a indirizzo ematologico
Orbassano, Italy
U.O. di Oncoematologia -plesso ospedaliero "A. Tortora" di Pagani
Pagani, Italy
...and 6 more locations
(ATRA plus chemotherapy versus ATRA plus ATO).
Time frame: Two years after study entry.