Long-term Outcomes for Acute Myeloid Leukemia Patients

Gruppo Italiano Malattie EMatologiche dell'Adulto343 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

343

Conditions

Acute Myeloid Leukemia

Interventions

QuestionnaireOTHER

Health-related quality of life

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (39)

Outcomes

Primary Outcomes

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.

Time frame: At enrollment

Secondary Outcomes

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

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

Time frame: At enrollment

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

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.

Time frame: At enrollment

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

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.

Time frame: At enrollment

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

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.

Time frame: At enrollment

Central Contacts

Francesca Tartaglia

CONTACT

+39 06 441639837 f.tartaglia@gimema.it

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 29 more locations