Long-term Outcomes for Acute Myeloid Leukemia Patients

NCT03755856 | Unknown

• 1 other identifier: GIMEMA-EORTC 1621-QLG-LG
• Study Type: observational
• Target: 343
• Locations: 7 countries
• Sites: 38

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.

Conditions

Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (1)

• Number of differences in SF-36 scores

  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.

  At enrollment

Secondary Outcomes (4)

• Outcomes from SF-36 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.

  At enrollment

• QoL profiles of AML survivors will be compared with those in the general population also as assessed by EORTC QLQ-C30 questionnaire.

  At enrollment

• Outcomes from SCQ questionnaire will be described and compared between AML patients from RCTs vs non RCTs.

  At enrollment

• Outcomes from EORTC QLQ-C30 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.

  At enrollment

Interventions

Questionnaire OTHER

Health-related quality of life

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study patients are acute myeloid leukemia long-term survivors

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead
• European Organisation for Research and Treatment of Cancer - EORTC: collaborator

Study Sites (39)

UZ Gasthuisberg

Leuven, Belgium

NOT YET RECRUITING

CHR Citadelle-CHU

Liège, Belgium

NOT YET RECRUITING

University of Liège

Liège, Belgium

NOT YET RECRUITING

KBC Rijeka

Rijeka, Croatia

NOT YET RECRUITING

University Hospital Centre Zagreb

Zagreb, Croatia

NOT YET RECRUITING

Les Hôpitaux Universitaires de Strasbourg

Lyon, France

NOT YET RECRUITING

Azienda Ospedaliero - Universitaria Ospedali Riuniti Umberto I - G.M. LANCISI - G. SALESI

Ancona, Italy

RECRUITING

U.O. Ematologia con trapianto - Azienda Ospedaliero-Universitaria Policlinico di Bari

Bari, Italy

RECRUITING

UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"

Barletta, Italy

NOT YET RECRUITING

Divisione di Ematologia Ospedale A. Perrino

Brindisi, Italy

RECRUITING

ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO

Cagliari, Italy

NOT YET RECRUITING

Divisione clinicizzata di Ematologia - Dipartimento di Scienze Mediche - Osp. Ferrarotto

Catania, Italy

RECRUITING

Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi

Cona, Italy

RECRUITING

Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria

Foggia, Italy

RECRUITING

IRCCS_AOU San Martino-IST.Clinica Ematologica

Genova, Italy

RECRUITING

Milano Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico UOC Oncoematologia- Padiglione Marcora 2° piano

Milan, Italy

RECRUITING

Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

Napoli, Italy

RECRUITING

UOC di Ematologia-Centro Emofilia e Trombosi - Ospedale Ascalesi - ASL Napoli 1

Napoli, Italy

NOT YET RECRUITING

S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

Novara, Italy

NOT YET RECRUITING

Orbassano Dip. di Scienze Cliniche e Biologiche - Ospedale S. Luigi Gonzaga-Medicina Interna 2

Orbassano, Italy

NOT YET RECRUITING

Università degli Studi di Padova - Ematologia ed Immunologia Clinica

Padua, Italy

NOT YET RECRUITING

U.O. di Ematologia con trapianto - A.U. Policlinico "Paolo Giaccone"

Palermo, Italy

RECRUITING

U.O. Ematologia e CTMO- AOU di Parma

Parma, Italy

RECRUITING

Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale G. da Saliceto

Piacenza, Italy

RECRUITING

Ematologia - Ospedale San Carlo

Potenza, Italy

RECRUITING

Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

Reggio Emilia, Italy

RECRUITING

Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia

Roma, Italy

RECRUITING

Divisione di Ematologia - Ospedale S.Eugenio

Roma, Italy

RECRUITING

Ematologia Policlinico - Università degli Studi di Roma Tor Vergata (PTV)

Roma, Italy

RECRUITING

Istituto di Semeiotica Medica - Ematologia - Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, Italy

RECRUITING

Roma Divisione Ematologia - Università Campus Bio-Medico

Roma, Italy

RECRUITING

Università degli Studi "Sapienza" - Dip Medicina di Precisione e Ricerca Traslazionale UOC Ematologia

Roma, Italy

RECRUITING

U.O. di Ematologia - Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

RECRUITING

Ematologia - AOU Sassari

Sassari, Italy

RECRUITING

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

RECRUITING

University Clinic of Hematology-Skopje

Skopje, North Macedonia

NOT YET RECRUITING

University hospital Bratislava

Bratislava, Slovakia

NOT YET RECRUITING

UKC Ljubljana

Ljubljana, Slovenia

NOT YET RECRUITING

Ankara University School Of Medicine Cebeci Campus Adult Hematology Department and BMT Unit

Ankara, Turkey (Türkiye)

NOT YET RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Fabio Efficace

  GIMEMA Foundation

  STUDY CHAIR

• Frédéric Baron

  European Organisation for Research and Treatment of Cancer - EORTC

  STUDY DIRECTOR

Central Study Contacts

Francesca Tartaglia

CONTACT

+39 06 441639837; f.tartaglia@gimema.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: November 28, 2018
• Study Start: May 16, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2022
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

CR (2); IT (29); TU (1); FR (1); NO (1); SL (1); BE (3)