Trial record 11 of 124 for:    "Acute promyelocytic leukemia"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier:
NCT01910623
First received: March 28, 2013
Last updated: October 1, 2014
Last verified: October 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
Study Completion Date: July 2014
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

Locations
Italy
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
Alessandria, Italy
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
Ancona, Italy
Az.Ospedaliera S.G.Moscati
Avellino, Italy
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari, Italy
Divisione di Ematologia - Ospedali Riuniti
Bergamo, Italy
Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi
Bologna, Italy
Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO
Bolzano, Italy
Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia
Brescia, Italy
ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO
Cagliari, Italy
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
Catania, Italy
Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia
Catanzaro, Italy
Policlinico di Careggi
Firenze, Italy
Clinica Ematologica - DiMI - Università degli Studi di Genova
Genova, Italy
IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente
Genova, Italy
Divisione di Ematologia Ospedale "Santa Maria Goretti"
Latina, Italy
Ospedale Niguarda " Ca Granda"
Milano, Italy
Centro Oncologico Modenese - Dipartimento di Oncoematologia
Modena, Italy
N. Osp. divisione di Ematologia "S.Gerardo dei Tintori!"
Monza, Italy
Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"
Napoli, Italy
Servizio Sanitario Nazionale - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Struttura Complessa di Ematologia - Div. TERE- 4° piano - Padiglione Palermo
Napoli, Italy
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
Napoli, Italy
Sez. di Ematologia Clinica Ospedale San Francesco
Nuoro, Italy
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
Palermo, Italy
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, Italy
Cattedra di Ematologia CTMO Università degli Studi di Parma
Parma, Italy
S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo
Pavia, Italy
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia
Perugia, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, Italy
Calabria Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
Reggio Calabria, Italy
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
Reggio Emilia, Italy
UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"
Roma, Italy
U.O.C. Ematologia - Ospedale S.Eugenio
Roma, Italy
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
Roma, Italy
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
S. G. Rotondo, Italy
SCDO Ematologia 2 AOU S.Giovanni Battista
Torino, Italy
Clinica Ematologica - Policlinico Universitario
Udine, Italy
Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi
Verona, Italy
ULSS N.6 Osp. S. Bortolo
Vicenza, Italy
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: October 1, 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
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 20, 2014