Clinical trial · Observational
Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia
Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia: a Follow-up Observational Study of Patients Enrolled in the GIMEMA AIDA 0493 and AIDA 200
NCT01910623CI-TRIAL-00015759QOL-APL0512completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will focus on acute promyelocytic leukemia patients who have been diagnosed more than 5 years ago and their present quality of life. The possible late effects of cancer treatment can include several issues and, thus, there has been an increasing interest worldwide in studying the long-term impact of these in patients' life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Promyelocytic Leukemia | Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Health Related Quality of Life (HRQOL) measures | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients being studied
- description
- APL patients previously enrolled in GIMEMA AIDA 0493 and AIDA 2000 studies.
- interventionNames
- Other: Health Related Quality of Life (HRQOL) measures
Primary outcomes (1)
- measure
- Clinical significance on each of the SF-36 questionnaire scales.
- timeFrame
- One month from study entry.
- description
- This will be performed by using HRQOL scores available for the Italian population. This will help identify which specific areas are mostly impaired and to what extent these patients recover in terms of HRQOL over the long run. This kind of comparison, which is only possible when HRQOL cultural-based norms are available, is largely used when investigating long-term HRQOL in cancer survivors and it is widely recognized as one of the most valuable approach in this kind of research setting.
Secondary outcomes (5)
- measure
- Association of EORTC-QLQC30 scales with social-demographic and clinical treatment related variables.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * APL patients previously enrolled in the studies GIMEMA AIDA0493 and AIDA2000 surviving the initial diagnosis for more than 5 years and are in CR. * Written informed consent provided. * Adult patients at the time of registration onto this study. Exclusion Criteria: * Concomitant major psychiatric disorders or cognitive dysfunctions that would interfere with a self-reported evaluation.
References
Publications (0)
Data not yet available
No reference posted for this study.