Clinical trial NCT01910623: Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Promyelocytic Leukemia
Keywords: Quality of life
Health related quality of life outcomes
Long-term
Aida 0493
AIDA 2000
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2013-07-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute promyelocytic patients previously enrolled in the studies GIMEMA AIDA0493 and AIDA2000

Brief summary: 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.

Detailed description: This study will focus on long-term survivors as defined by the America Cancer Society, that is surviving the initial diagnosis for more than 5 years. Previous research has investigated long-term Health Related Quality of Life (HRQOL) in patients with acute myeloid leukemia, however, this will be the first research conducted to investigate long-term HRQOL outcomes in patients with acute promyelocytic leukemia (APL).

The potential late effects of cancer treatment can include second malignancies or other chronic conditions affecting physical and emotional well-being. Therefore, there has been an increasing interest worldwide in evaluating the longer-term impact of cancer and its treatment. Currently large cohort of patients enjoys disease-free survival of 5 years or longer. However, a disease-free status is not synonymous with a life free of physical and psychological health related to the cancer and/or its treatment. Research shows that cancer related health concerns persist long after initial treatment and this has been shown in several cancer populations including prostate, testicular, breast cancer and lymphoma patients. Long-term cancer survivors can experience treatment-induced morbidity (e.g. cardiovascular damage due to chemotherapy or radiotherapy; infertility and second tumors), chronic disease and treatment-related symptoms, functional impairment, psychosocial problems, and practical problems.

Since the introduction of the vitamin A derivative all-trans retinoic acid (ATRA) as front-line therapy for APL, the outcome of this acute leukemia subtype has changed from the state of a most frequently fatal leukemia to the condition of a highly curable disease. The Italian cooperative group GIMEMA designed in 1993 the AIDA (Atra plus IDArubicin) trial for newly diagnosed APL. Results on over 800 patients showed a complete remission (CR) rate \> 90% and an overall survival of 76% and confirmed that the concomitant administration of ATRA and chemotherapy is more effective than the sequential administration. Following the identification of distinct prognostic categories among APL patients, the GIMEMA group designed a new trial (AIDA2000) in which the intensity of post-remission treatment was adapted to the relapse risk and 498 patients were enrolled since January 2000. The results recently published showed a CR rate \>90% with molecular remission rate after third consolidation of 98%. The new schedule allowed a Disease Free Survival (DFS) of 86% and showed that a risk-adapted strategy including ATRA for consolidation provides an outcome improvement in newly diagnosed patients. As reported by an international panel of experts, simultaneous ATRA and anthracycline chemotherapy schedules such as those used in the AIDA protocols represent the state of the art therapy for newly diagnosed APL.

Eligibility criteria: 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.

Primary outcomes:
measure: Clinical significance on each of the SF-36 questionnaire scales.
timeFrame: One month from study entry.
Secondary outcomes:
measure: Association of EORTC-QLQC30 scales with social-demographic and clinical treatment related variables.
timeFrame: One month from study entry.
measure: Association of MDASI scales (i.e., symptom severity and symptom interference) with different treatment strategies tested in the two GIMEMA trials.
timeFrame: One month from study entry.
measure: Association of EORTC-QLQC30 scales with different treatment strategies tested in the two GIMEMA trials.
timeFrame: One month from study entry.
measure: Association of rate of secondary malignancies with different treatment strategies tested in the two GIMEMA trials.
timeFrame: One month from study entry
measure: Possible differences in EORTC-QLQC30, MDASI and SF-36 scales between patients who were less than eighteen years old at the time of diagnosis and patients who were at least eighteen years old at the time of diagnosis.
timeFrame: One month from study entry
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
city: Ancona
country: Italy
facility: Azienda Ospedaliera - Nuovo Ospedale "Torrette"
city: Avellino
country: Italy
facility: Az.Ospedaliera S.G.Moscati
city: Bari
country: Italy
facility: UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
city: Bergamo
country: Italy
facility: Divisione di Ematologia - Ospedali Riuniti
city: Bologna
country: Italy
facility: Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
city: Bolzano
country: Italy
facility: Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO
city: Brescia
country: Italy
facility: Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia
city: Cagliari
country: Italy
facility: ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
city: Catania
country: Italy
facility: Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
city: Firenze
country: Italy
facility: Policlinico di Careggi
city: Genova
country: Italy
facility: Clinica Ematologica - DiMI - Università degli Studi di Genova
city: Genova
country: Italy
facility: IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
city: Latina
country: Italy
facility: Divisione di Ematologia Ospedale "Santa Maria Goretti"
city: Milano
country: Italy
facility: Ospedale Niguarda " Ca Granda"
city: Modena
country: Italy
facility: Centro Oncologico Modenese - Dipartimento di Oncoematologia
city: Monza
country: Italy
facility: N. Osp. divisione di Ematologia "S.Gerardo dei Tintori!"
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
city: Napoli
country: Italy
facility: Servizio Sanitario Nazionale - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Struttura Complessa di Ematologia - Div. TERE- 4° piano - Padiglione Palermo
city: Nuoro
country: Italy
facility: Sez. di Ematologia Clinica Ospedale San Francesco
city: Palermo
country: Italy
facility: Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
city: Palermo
country: Italy
facility: Ospedali Riuniti "Villa Sofia-Cervello"
city: Parma
country: Italy
facility: Cattedra di Ematologia CTMO Università degli Studi di Parma
city: Pavia
country: Italy
facility: S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
city: Perugia
country: Italy
facility: Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
city: Pescara
country: Italy
facility: U.O. Ematologia Clinica - Azienda USL di Pescara
city: Reggio Calabria
country: Italy
facility: Calabria Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
city: Reggio Emilia
country: Italy
facility: Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
city: Roma
country: Italy
facility: U.O.C. Ematologia - Ospedale S.Eugenio
city: Roma
country: Italy
facility: Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
city: Roma
country: Italy
facility: UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
city: S. G. Rotondo
country: Italy
facility: Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
city: Torino
country: Italy
facility: SCDO Ematologia 2 AOU S.Giovanni Battista
city: Udine
country: Italy
facility: Clinica Ematologica - Policlinico Universitario
city: Verona
country: Italy
facility: Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
city: Vicenza
country: Italy
facility: ULSS N.6 Osp. S. Bortolo
Study officials:
affiliation: GIMEMA Foundation
name: Fabio Efficace, PhD
role: PRINCIPAL_INVESTIGATOR
References: