Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy

Study Overview
=================
Brief Summary
-----------------
This is a prospective and international observational study run by the GIMEMA. All data will be centrally collected and analyzed at the GIMEMA Data Center in Rome (Italy). Patients reported outcomes will be collected using internationally validated questionnaires.

Official Title
-----------------
Long-term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia (APL) Patients Treated With Arsenic Trioxide (ATO) or Standard Chemotherapy

Conditions
-----------------
Acute Promyelocytic Leukemia

Intervention / Treatment
-----------------
* Other: QoL questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: APL survivors enrolled in GIMEMA APL0406 clinical trial and in first molecular CR after third consolidation treatment Written informed consent. Exclusion Criteria: APL patients previously enrolled in GIMEMA APL0406 trial who cannot be reached or who are lost to follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GIMEMA APL0406 patients<br>APL survivors previously enrolled in GIMEMA APL0406 clinical trial and in 1st molecular CR after third consolidation treatment. | Other: QoL questionnaires<br>* Quality of life questionnaires<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine cross-sectional long-term differences in health outcomes after treatment end. | Indicated by selected key-QoL outcomes (i.e. Fatigue, Cognitive and Role functioning scales from the EORTC-QLQ-C30 questionnaire), between APL patients treated with ATRA plus chemotherapy versus patients treated with ATRA plus ATO. | Two years after study entry. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine long-term differences in health outcomes after treatment end indicated by all QoL outcomes not considered in primary objectives, between APL patients treated with ATRA plus chemotherapy versus patients treated with ATRA plus ATO. | (including the functional status and symptomatology). | Two years after study entry. | 
| To investigate clinical, laboratory, socio-demographic and QoL factors predicting long-term health/QoL outcomes of APL patients after treatment end. | (as reported at 3rd consolidation). | Two years after study entry. | 
| To compare the long-term QoL profile, after treatment end, of APL patients treated with ATRA- chemotherapy and ATRA-ATO with that of their peers in the general population. | Compared with the general population (without cancer). | Two years after study entry. | 
| To assess and compare the cumulative incidence and types of physician-reported late adverse effects (e.g. cardiac function) and secondary cancer, between randomized treatment groups. | (ATRA plus chemotherapy versus ATRA plus ATO). | Two years after study entry. | 
| To assess and compare the prevalence of long-term patient-reported comorbidities and symptoms, after treatment end, between randomized treatment groups. | (ATRA plus chemotherapy versus ATRA plus ATO). | Two years after study entry. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality of life, acute promyelocytic leukemia, ATO