NCT03755856
Unknown
Not Applicable
A Survivorship Project to UnerstAnd and to impRove Long-Term Outcomes for Acute Myeloid Leukemia Patients (SPARTA): the Sparta Platform
Gruppo Italiano Malattie EMatologiche dell'Adulto39 sites in 8 countries343 target enrollmentStarted: May 16, 2019Last updated:
ConditionsAcute Myeloid Leukemia
Overview
- Phase
- Not Applicable
- Enrollment
- 343
- Locations
- 39
- Primary Endpoint
- Number of differences in SF-36 scores
Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Number of differences in SF-36 scores
Time Frame: 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 Outcomes
- Outcomes from SF-36 questionnaire will be described and compared between AML patients from RCTs vs non RCTs.(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)
- QoL profiles of AML survivors will be compared with those in the general population also as assessed by EORTC QLQ-C30 questionnaire.(At enrollment)
Investigators
Study Sites (39)
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