Occupational Status and Hematological Disease (EMATO0113)
|ClinicalTrials.gov Identifier: NCT02057185|
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : October 6, 2020
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|
|Study Type :||Observational|
|Actual Enrollment :||141 participants|
|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|
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
- 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.
- 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)
- 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.
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057185
|UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro|
|Ospedali Riuniti "Villa Sofia-Cervello"|
|U.O. Ematologia Clinica - Azienda USL di Pescara|
|Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia|
|ULSS N.6 Osp. S. Bortolo|
|Study Chair:||Edoardo La Sala||GIMEMA Foundation|