Long-Term Quality of Life in Patients With Acute Promyelocytic Leukemia

NCT01910623 | Completed

• 1 other identifier: QOL-APL0512
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 38

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.

Conditions

Acute Promyelocytic Leukemia

Keywords

Quality of life; Health related quality of life outcomes; Long-term; Aida 0493; AIDA 2000

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

Study Arms (1)

Patients being studied

APL patients previously enrolled in GIMEMA AIDA 0493 and AIDA 2000 studies.

Other: Health Related Quality of Life (HRQOL) measures

Interventions

Health Related Quality of Life (HRQOL) measures OTHER

Also known as: 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).

Patients being studied

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Concomitant major psychiatric disorders or cognitive dysfunctions that would interfere with a self-reported evaluation.

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead

Study Sites (38)

S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo

Alessandria, Italy

Location

Azienda Ospedaliera - Nuovo Ospedale "Torrette"

Ancona, Italy

Location

Az.Ospedaliera S.G.Moscati

Avellino, Italy

Location

UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro

Bari, Italy

Location

Divisione di Ematologia - Ospedali Riuniti

Bergamo, Italy

Location

Istituto di Ematologia "Lorenzo e A. Seragnoli" - Università degli Studi di Bologna - Policlinico S. Orsola - Malpighi

Bologna, Italy

Location

Azienda Sanitaria di Bolzano - Ospedale Centrale - Ematologia e Centro TMO

Bolzano, Italy

Location

Spedali Civili - Brescia - Azienda Ospedaliera - U.O. Ematologia

Brescia, Italy

Location

ASL N.8 - Ospedale "A. Businco" - Struttura Complessa di Ematologia e CTMO

Cagliari, Italy

Location

Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

Catania, Italy

Location

Azienda Ospedaliera Pugliese Ciaccio - Presidio Ospedaliero A.Pugliese - Unità Operativa di Ematologia

Catanzaro, Italy

Location

Policlinico di Careggi

Florence, Italy

Location

Clinica Ematologica - DiMI - Università degli Studi di Genova

Genova, Italy

Location

IRCCS_AOU San Martino-IST-Ematologia 1-Monoblocco 11°piano- lato ponente

Genova, Italy

Location

Divisione di Ematologia Ospedale "Santa Maria Goretti"

Latina, Italy

Location

Ospedale Niguarda " Ca Granda"

Milan, Italy

Location

Centro Oncologico Modenese - Dipartimento di Oncoematologia

Modena, Italy

Location

N. Osp. divisione di Ematologia "S.Gerardo dei Tintori!"

Monza, Italy

Location

Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli"

Napoli, Italy

Location

Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

Napoli, Italy

Location

Servizio Sanitario Nazionale - Azienda Ospedaliera di Rilievo Nazionale "A. Cardarelli" - Struttura Complessa di Ematologia - Div. TERE- 4° piano - Padiglione Palermo

Napoli, Italy

Location

Sez. di Ematologia Clinica Ospedale San Francesco

Nuoro, Italy

Location

Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"

Palermo, Italy

Location

Ospedali Riuniti "Villa Sofia-Cervello"

Palermo, Italy

Location

Cattedra di Ematologia CTMO Università degli Studi di Parma

Parma, Italy

Location

S.C. Ematologia - Fondazione IRCCS Policlinico S. Matteo

Pavia, Italy

Location

Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della Misericordia

Perugia, Italy

Location

U.O. Ematologia Clinica - Azienda USL di Pescara

Pescara, Italy

Location

Calabria Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"

Reggio Calabria, Italy

Location

Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

Reggio Emilia, Italy

Location

U.O.C. Ematologia - Ospedale S.Eugenio

Roma, Italy

Location

Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

Roma, Italy

Location

UOC Pronto Soccorso e Accettazione Ematologica - Dipartimento Biotecnologie Cellulari ed Ematologia - Università degli Studi di Roma "Sapienza"

Roma, Italy

Location

Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

S. G. Rotondo, Italy

Location

SCDO Ematologia 2 AOU S.Giovanni Battista

Torino, Italy

Location

Clinica Ematologica - Policlinico Universitario

Udine, Italy

Location

Università degli Studi di Verona - A. O. - Istituti Ospitalieri di Verona- Div. di Ematologia - Policlinico G.B. Rossi

Verona, Italy

Location

ULSS N.6 Osp. S. Bortolo

Vicenza, Italy

Location

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Interventions

Quality of Life; Weights and Measures

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, Acute; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Investigative Techniques

Study Officials

• Fabio Efficace, PhD

  GIMEMA Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: July 29, 2013
• Study Start: February 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: October 2, 2014

Record last verified: 2014-10

Locations

IT (38)