Acute Myeloid Leukemia
Conditions
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.
Interventions
OTHERQuestionnaire
Health-related quality of life
Sponsors
European Organisation for Research and Treatment of Cancer - EORTC
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
Countries
Belgium, Croatia, France, Italy, North Macedonia, Slovakia, Slovenia, Turkey (Türkiye)
Contacts
Primary ContactFrancesca Tartaglia
Outcome results
None listed