Trial record 11 of 123 for:    "acute promyelocytic leukemia"

Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia (QOL-APL0512)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01910623
First received: March 28, 2013
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Acute Promyelocytic Leukemia
Other: Health Related Quality of Life (HRQOL) measures

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
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

Resource links provided by NLM:


Further study details as provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:

Primary Outcome Measures:
  • Clinical significance on each of the SF-36 questionnaire scales. [ Time Frame: One month from study entry. ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Association of EORTC-QLQC30 scales with social-demographic and clinical treatment related variables. [ Time Frame: One month from study entry. ] [ Designated as safety issue: No ]
  • Association of MDASI scales (i.e., symptom severity and symptom interference) with different treatment strategies tested in the two GIMEMA trials. [ Time Frame: One month from study entry. ] [ Designated as safety issue: No ]
  • Association of EORTC-QLQC30 scales with different treatment strategies tested in the two GIMEMA trials. [ Time Frame: One month from study entry. ] [ Designated as safety issue: No ]
  • Association of rate of secondary malignancies with different treatment strategies tested in the two GIMEMA trials. [ Time Frame: One month from study entry ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: One month from study entry ] [ Designated as safety issue: No ]

Study Start Date: February 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients being studied
APL patients previously enrolled in GIMEMA AIDA 0493 and AIDA 2000 studies.
Other: Health Related Quality of Life (HRQOL) measures
Other Names:
  • SF-36 health survey.
  • EORTC QOL-C30 questionnaire.
  • FACIT-Fatigue questionnaire.
  • Self-administered Comorbidity Questionnaire (SCQ).
  • Multidimensional Scale of Perceived Social Support (MSPSS).
  • MD Anderson Symptom Inventory (MDASI).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Acute promyelocytic patients previously enrolled in the studies GIMEMA AIDA0493 and AIDA2000

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01910623

Contacts
Contact: Fabio Efficace, PhD f.efficace@gimema.it

Locations
Italy
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo Recruiting
Alessandria, Italy
Contact: Lorella De Paoli, Dr.       ldepaoli@ospedale.al.it   
Principal Investigator: Lorella De Paoli, Dr.         
Sub-Investigator: Stefania Tamiazzo, Dr.         
Azienda Ospedaliera - Nuovo Ospedale "Torrette" Recruiting
Ancona, Italy
Contact: Pietro Leoni, Dr.       pleoni@univpm.it   
Principal Investigator: Pietro Leoni, Dr.         
Sub-Investigator: Anna Rita Scortechini, Dr.         
Az.Ospedaliera S.G.Moscati Recruiting
Avellino, Italy
Contact: Nicola Cantore, Dr.       n.cantore@virgilio.it   
Principal Investigator: Nicola Cantore, Dr.         
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro Not yet recruiting
Bari, Italy
Contact: Giorgina Specchia, Pr.       g.specchia@ematba.uniba.it   
Principal Investigator: Giorgina Specchia, Pr.         
Divisione di Ematologia - Ospedali Riuniti Recruiting
Bergamo, Italy
Contact: Alessandro Rambaldi, Pr.       arambaldi@ospedaliriuniti.bergamo.it   
Principal Investigator: Alessandro Rambaldi, Pr.         
Sub-Investigator: Maria Luisa Ferrari, Dr.         
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi Recruiting
Bologna, Italy
Contact: Giovanni Martinelli, Pr.       martg@tin.it   
Principal Investigator: Michele Martinelli, Pr.         
Sub-Investigator: Silvia Piccari, Dr.         
Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO Recruiting
Bolzano, Italy
Contact: Vincenzo Cassiba, Dr.       vincenzo.cassibba@asbz.it   
Principal Investigator: Vincenzo Cassiba, Dr.         
Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia Recruiting
Brescia, Italy
Contact: Giuseppe Rossi, Dr.       rossig@med.unibs.it   
Principal Investigator: Giuseppe Rossi, Dr.         
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO Recruiting
Cagliari, Italy
Contact: Emanuele Angelucci, Pr.       emnang@tin.it   
Principal Investigator: Emanuele Angelucci, Pr.         
Sub-Investigator: Claudio Romani, Dr.         
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto" Recruiting
Catania, Italy
Contact: Francesco Di Raimondo, Pr.       diraimon@unict.it   
Principal Investigator: Francesco Di Raimondo, Pr.         
Sub-Investigator: Dorina Cultrera, Dr.         
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia Not yet recruiting
Catanzaro, Italy
Contact: Stefano Molica, Dr.       smolica@libero.it   
Principal Investigator: Stefano Molica, Dr.         
Policlinico di Careggi Recruiting
Firenze, Italy
Contact: Alberto Bosi, Dr.       alberto.bosi@unifi.it   
Principal Investigator: Alberto Bosi         
IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente Recruiting
Genova, Italy
Contact: Angelo Michele Carella, Dr.       angelomichele.carella@hsanmartino.it   
Principal Investigator: Angelo Michele Carella, Dr.         
Sub-Investigator: Giammatteo Pica, Dr.         
Clinica Ematologica - DiMI - Università degli Studi di Genova Recruiting
Genova, Italy
Contact: Marco Gobbi, Pr.       gobbi@unige.it   
Principal Investigator: Marco Gobbi, Pr.         
Divisione di Ematologia Ospedale "Santa Maria Goretti" Recruiting
Latina, Italy
Contact: Angelo De Blasio, Dr.       emato@online.latina.it   
Principal Investigator: Angelo De Blasio, Dr.         
Ospedale Niguarda " Ca Granda" Recruiting
Milano, Italy
Contact: Valentina Mancini, Dr.       valentina.mancini@ospedaleniguarda.it   
Principal Investigator: Valentina Mancini, Dr.         
Sub-Investigator: Eleonora Piraino, Dr.         
Centro Oncologico Modenese - Dipartimento di Oncoematologia Recruiting
Modena, Italy
Contact: Monica Morselli, Dr.       morselli.monica@policlinico.mo.it   
Principal Investigator: Monica Morselli, Dr.         
Sub-Investigator: Giulia Debbia, Dr.         
N. Osp. divisione di Ematologia "S.Gerardo dei Tintori!" Recruiting
Monza, Italy
Contact: Enrico Maria Pogliani, Dr.       enrico.pogliani@unimib.it   
Principal Investigator: Enrico Maria Pogliani, Dr.         
Sub-Investigator: Monica Fumagalli, Dr.         
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia Recruiting
Napoli, Italy
Contact: Fabrizio Pane, Dr.       fabrizio.pane@unina.it   
Principal Investigator: Fabrizio Pane, Pr.         
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" Recruiting
Napoli, Italy
Contact: Felicetto Ferrara, Pr.       felicettoferrara@katamail.com   
Principal Investigator: Felicetto Ferrara, Pr.         
Servizio Sanitario Nazionale - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Struttura Complessa di Ematologia - Div. TERE- 4° piano - Padiglione Palermo Not yet recruiting
Napoli, Italy
Contact: Vincenzo Mettivier, Pr.       ematologia_cardarel@libero.it   
Principal Investigator: Vincenzo Mettivier, Pr.         
Sez. di Ematologia Clinica Ospedale San Francesco Recruiting
Nuoro, Italy
Contact: Giancarlo Latte, Dr.         
Principal Investigator: Giancarlo Latte, Dr.         
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone" Recruiting
Palermo, Italy
Contact: Vincenzo Abbadessa, Pr.         
Principal Investigator: Vincenzo Abbadessa, Pr.         
Sub-Investigator: Maria Enza Mitra, Dr.         
Ospedali Riuniti "Villa Sofia-Cervello" Recruiting
Palermo, Italy
Contact: Francesco Fabbiano, Pr.       fabbianofrancesco@tiscali.it   
Principal Investigator: Francesco Fabbiano, Pr.         
Cattedra di Ematologia CTMO Università degli Studi di Parma Recruiting
Parma, Italy
Contact: Cecilia Caramatti, Dr.       cecilia.caramatti@unipr.it   
Principal Investigator: Cecilia Caramatti, Dr.         
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo Not yet recruiting
Pavia, Italy
Contact: Mario Cazzola, Dr.       mario.cazzola@unipv.it   
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia Recruiting
Perugia, Italy
Contact: Brunangelo Falini, Dr.       faliniem@unipg.it   
Principal Investigator: Brunangelo Falini, Dr.         
Sub-Investigator: Maria Paola Martelli, Dr.         
U.O. Ematologia Clinica - Azienda USL di Pescara Recruiting
Pescara, Italy
Contact: Giuseppe Fioritoni, Pr.       gfioritoni@tin.it   
Principal Investigator: Giuseppe Fioritoni, Pr.         
Sub-Investigator: Anna Recchia, Dr.         
Calabria Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli" Recruiting
Reggio Calabria, Italy
Contact: Francesco Nobile, Pr.       nobilefranc@gmail.com   
Principal Investigator: Francesco Nobile, Pr.         
Sub-Investigator: Caterina Alati, Dr.         
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova Not yet recruiting
Reggio Emilia, Italy
Contact: Francesco Merli, Dr.       francesco.merli@asmn.re.it   
Principal Investigator: Francesco Merli, Dr.         
U.O.C. Ematologia - Ospedale S.Eugenio Recruiting
Roma, Italy
Contact: Paolo De Fabritiis, Pr.       paolo.de.fabritiis@uniroma2.it   
Principal Investigator: Paolo De Fabritiis, Pr.         
UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza" Recruiting
Roma, Italy
Contact: Giuliana Alimena, Pr.       alimena@bce.uniroma1.it   
Principal Investigator: Giuliana Alimena, Pr.         
Sub-Investigator: Massimo Breccia, Dr.         
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli Recruiting
Roma, Italy
Contact: Giuseppe Leone, Pr.       gleone@rm.unicatt.it   
Principal Investigator: Giuseppe Leone, Pr.         
Sub-Investigator: Simona Sica, Dr.         
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza Recruiting
S. G. Rotondo, Italy
Contact: Nicola Cascavilla, Pr.       n.cascavilla@operapadrepio.it   
Principal Investigator: Nicola Cascavilla, Pr.         
SCDO Ematologia 2 AOU S.Giovanni Battista Recruiting
Torino, Italy
Contact: Umberto Vitolo, Dr.       uvitolo@molinette.piemonte.it   
Principal Investigator: Umberto Vitolo, Dr.         
Sub-Investigator: Stefano D'ardia, Dr.         
Clinica Ematologica - Policlinico Universitario Recruiting
Udine, Italy
Contact: Renato Fanin, Pr.       renato.fanin@uniud.it   
Principal Investigator: Renato Fanin, Pr.         
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi Recruiting
Verona, Italy
Contact: Giovanni Pizzolo, Pr.       giovanni.pizzolo@univr.it   
Principal Investigator: Giovanni Pizzolo, Pr.         
ULSS N.6 Osp. S. Bortolo Recruiting
Vicenza, Italy
Contact: Francesco Rodeghiero, Pr.       rodeghiero@hemato.ven.it   
Principal Investigator: Francesco Rodeghiero, Pr.         
Sub-Investigator: Eros Di Bona, Dr.         
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Investigators
Principal Investigator: Fabio Efficace, PhD GIMEMA Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT01910623     History of Changes
Other Study ID Numbers: QOL-APL0512
Study First Received: March 28, 2013
Last Updated: January 30, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Quality of life
Health related quality of life outcomes
Long-term
Aida 0493
AIDA 2000

Additional relevant MeSH terms:
Leukemia
Leukemia, Promyelocytic, Acute
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid, Acute
Leukemia, Myeloid

ClinicalTrials.gov processed this record on July 28, 2014