Occupational Status and Hematological Disease

NCT02057185 | Completed

• 1 other identifier: EMATO 0113
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 6

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.

Conditions

Chronic Myeloid Leukemia; Chronic Lymphocytic Leukemia; Myelodysplastic Syndrome; Chronic Thrombocytopenia; Hodgkin Disease

Keywords

Chronic Hematological Diseases; work; job

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who lost their job as a consequence of the disease.

  Evaluated only once during the first outpatient visit in the study time window.

  Three months.

Secondary Outcomes (3)

• Correlation between health status and occupational status.

  Three months.

• Predictors of return to work in patients with a chronic blood disease.

  Three months.

• Proportion of patients needing external support to return to work.

  Three months.

Study Arms (1)

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; Behavioral: SF-36 Questionnaire

Interventions

Study questionnaire BEHAVIORAL

Questionnaire based on work situation of enrolled patients.

Study population

SF-36 Questionnaire BEHAVIORAL

Version 1.6

Study population

Eligibility Criteria

• Age: 15 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Gruppo Italiano Malattie EMatologiche dell'Adulto: lead
• Fondazione Adecco per le Pari Opportunità: collaborator

Study Sites (6)

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

Bari, Italy

Location

Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti

Genzano di Roma, Italy

Location

Ospedali Riuniti "Villa Sofia-Cervello"

Palermo, Italy

Location

U.O. Ematologia Clinica - Azienda USL di Pescara

Pescara, Italy

Location

Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

Roma, Italy

Location

ULSS N.6 Osp. S. Bortolo

Vicenza, Italy

Location

Related Links

• GIMEMA Foundation

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Lymphocytic, Chronic, B-Cell; Myelodysplastic Syndromes; Hodgkin Disease

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, B-Cell; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma

Study Officials

• Edoardo La Sala

  GIMEMA Foundation

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: February 6, 2014
• Study Start: September 8, 2014
• Primary Completion: November 11, 2015
• Study Completion: November 11, 2015
• Last Updated: February 7, 2024

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (6)