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Occupational Status and Hematological Disease (EMATO0113)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02057185
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : October 6, 2020
Sponsor:
Collaborator:
Fondazione Adecco per le Pari Opportunità
Information provided by (Responsible Party):
Gruppo Italiano Malattie EMatologiche dell'Adulto

Brief Summary:

Diseases do not only have a physical role in people's live, but they usually involve changes in life as whole. They may modify the structure of the conjunction with life setting, thus, deeply impacting relationships with others. While clinical results of new therapies for hematological diseases are well documented in scientific literature in terms of prolonged life expectancy or remission from disease, less is known about problems and barriers preventing the return of patients with a chronic blood ailment to everyday life.

Indeed, there are no published data on this topic within the Italian context. The present explorative study aims at identifying the main problems with which patients affected by a Chronic Hematological Disease (CHD) deal when returning to everyday working life, factors associated with work reintegration and, finally, to understand the need for facilitators enhancing reintegration outcomes.

Results from this study will be also helpful to raise consciousness about the problem of reintegration into the labour market of workers with CHD and to call for awareness campaigns for the general public and health professionals.


Condition or disease Intervention/treatment
Chronic Myeloid Leukemia Chronic Lymphocytic Leukemia Myelodysplastic Syndrome Chronic Thrombocytopenia Hodgkin Disease Behavioral: Study questionnaire Behavioral: SF-36 Questionnaire

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Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Occupational Status and Hematological Disease: Effects and Counseling Needs
Actual Study Start Date : September 8, 2014
Actual Primary Completion Date : November 11, 2015
Actual Study Completion Date : November 11, 2015


Group/Cohort Intervention/treatment
Study population

Patients diagnosed with Chronic Myeloid Leukaemia, Chronic Lymphocytic Leukaemia, Myelodysplastic Syndromes (low risk), Chronic Thrombocytopenia or Hodgkin Disease in complete remission, who have signed written informed consent according to ICH/EU/GCP and Italian laws, aged between 15 and 74 years old.

The study excludes non Italian speaking patients or unable to fully understand the study's forms.

Behavioral: Study questionnaire
Questionnaire based on work situation of enrolled patients.

Behavioral: SF-36 Questionnaire
Version 1.6




Primary Outcome Measures :
  1. Proportion of patients who lost their job as a consequence of the disease. [ Time Frame: Three months. ]
    Evaluated only once during the first outpatient visit in the study time window.


Secondary Outcome Measures :
  1. Correlation between health status and occupational status. [ Time Frame: Three months. ]
    Evaluated only once during the first outpatient visit in the study time window. Outcome measure is a patient reported outcome (PRO)

  2. Predictors of return to work in patients with a chronic blood disease. [ Time Frame: Three months. ]
    We will test patient data relationship with occupational status in a multivariate analysis.

  3. Proportion of patients needing external support to return to work. [ Time Frame: Three months. ]
    Evaluated only once during the first outpatient visit in the study time window. Outcome measure is a patient reported outcome (PRO)



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Ages Eligible for Study:   15 Years to 74 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with a chronic hematological disease aged between 15 and 74 years old fully able to understand Italian.
Criteria

Inclusion Criteria:

  • Being diagnosed Chronic Myeloid Leukaemia, Chronic Lymphocytic Leukaemia, Myelodysplastic Syndromes (low risk), Chronic Thrombocytopenia or Hodgkin Disease in complete remission.
  • Signed written informed consent according to ICH/EU/GCP and national local laws.
  • Age between 15 and 74 years old.

Exclusion Criteria:

  • Not Italian speaking or unable to fully understand the study's forms.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057185


Locations
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Italy
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari, Italy
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo, Italy
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara, Italy
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma, Italy
ULSS N.6 Osp. S. Bortolo
Vicenza, Italy
Sponsors and Collaborators
Gruppo Italiano Malattie EMatologiche dell'Adulto
Fondazione Adecco per le Pari Opportunità
Investigators
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Study Chair: Edoardo La Sala GIMEMA Foundation
Additional Information:
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Responsible Party: Gruppo Italiano Malattie EMatologiche dell'Adulto
ClinicalTrials.gov Identifier: NCT02057185    
Other Study ID Numbers: EMATO 0113
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: October 6, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gruppo Italiano Malattie EMatologiche dell'Adulto:
Chronic Hematological Diseases
work
job
Additional relevant MeSH terms:
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Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Hodgkin Disease
Myelodysplastic Syndromes
Thrombocytopenia
Hematologic Diseases
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Blood Platelet Disorders
Leukemia, Myeloid
Myeloproliferative Disorders
Lymphoma