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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Promyelocytic Leukemia
• Intervention / Treatment: Other: Health Related Quality of Life (HRQOL) measures

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.

• Study Type: Observational

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical significance on each of the SF-36 questionnaire scales.	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.	One month from study entry.

Secondary Outcome Measures

Outcome Measure	Time Frame
Association of EORTC-QLQC30 scales with social-demographic and clinical treatment related variables.	One month from study entry.
Association of MDASI scales (i.e., symptom severity and symptom interference) with different treatment strategies tested in the two GIMEMA trials.	One month from study entry.
Association of EORTC-QLQC30 scales with different treatment strategies tested in the two GIMEMA trials.	One month from study entry.
Association of rate of secondary malignancies with different treatment strategies tested in the two GIMEMA trials.	One month from study entry
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.	One month from study entry

Collaborators and Investigators

• Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
• Investigators: Principal Investigator: Fabio Efficace, PhD, GIMEMA Foundation

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: March 28, 2013
• First Submitted That Met QC Criteria: July 25, 2013
• First Posted (Estimate): July 29, 2013

Study Record Updates

• Last Update Posted (Estimate): October 2, 2014
• Last Update Submitted That Met QC Criteria: October 1, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Quality of life; Long-term; Health related quality of life outcomes; Aida 0493; AIDA 2000
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia; Leukemia, Promyelocytic, Acute
• Other Study ID Numbers: QOL-APL0512