Chronic Myeloid LeukemiaEMATO0113NCT02057185
Occupational Status and Hematological Disease
An observational study of Chronic Myeloid Leukemia and Chronic Lymphocytic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 6 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 74 years
- Conditions the study is for
- Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myelodysplastic Syndrome
- What is being tested?
- Study questionnaire and SF-36 Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 141 participants
- Where
- 6 sitesItaly
- Study dates
- 8 Sep 2014to 11 Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 74 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a chronic hematological disease aged between 15 and 74 years old fully able to understand Italian.
Who may be able to join
- 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.
Who cannot join
- Not Italian speaking or unable to fully understand the study's forms.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Italy6 sites
UO Ematologia con trapianto-Università degli Studi di Bari Aldo Moro
Bari
Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti
Genzano di Roma
Ospedali Riuniti "Villa Sofia-Cervello"
Palermo
U.O. Ematologia Clinica - Azienda USL di Pescara
Pescara
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
Roma
ULSS N.6 Osp. S. Bortolo
Vicenza
About this study
Official title: Occupational Status and Hematological Disease: Effects and Counseling Needs
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.
Read the detailed description
A disease doesn't have only a physical side but usually involves changes in the person as whole. It changes the structure of the relationship between a person and his life setting, deeply impacting the way her/he relates to others and to himself. While clinical results of new therapies about hematological pathologies 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.
A number of economists have argued that there is a causal link between increasing inequality and the financial crisis. Evidence from different EU Member States shows that people who declare themselves as being permanently disabled are over-represented among people at risk of poverty or social exclusion compared to the whole population.
In Italy, in the second quarter of 2011, 6 million 556 thousand people aged 15-64 years (16.5% of the population of this age group) claimed to be suffering from one or more longstanding health problems or functional difficulties.
Health problems represent a barrier to the inclusion in the labour market. More than 50% of those suffering from more than one health problem or functional difficulties is inactive, this share decreases significantly among those who complain about one problem or difficulty (39.9%) and no problem (35.5%).
Among persons employed who complain of poor health conditions, about one in 10 may rely on one or more types of assistance in their place of work: availability of special equipment or workplace adaptations, personal service, special working arrangements. Among people who do not have a job, however, more than a quarter (26.6%) would need to receive at least one type of assistance in order to work.
People with long-term illnesses have an higher probability of leaving the workforce at an early age and people who continue to work despite health problems are likely to be less productive than healthy people. Thus, without a timely and appropriate reintegration, they may be less likely to return to work.
In this scenario it's of utmost importance to increase the overall capability to deliver targeted actions in order to be able to support people at risk of social -work exclusion.
Policy instruments being able to provide access to the labour market also play an important role, as well as measures in favor of education. Studies have shown several benefits associated with returning to work after cancer, including addressing financial needs, providing a distraction and an overall improvement in quality of life. Health professionals advice and support and the role of the employers in providing a sound workplace accommodation may play an important role in this regard but, on the other hand, a number of studies show an association between cancer survivorship and risk of unemployment.
The impact of returning to work after (or during) a long-term illness must be evaluated also from the perspective of the family and of the community. It could be very hard for partners and other relatives to conciliate their work duties with the task of taking care of the sick person - in terms of time and of mental strain. While laws usually allow for a number of measures to ease this issue, more information is often needed to workers and to employers.
The cost of a sick worker, from the viewpoint of the community, includes not only the cost of health care and rehabilitation but also the lost productivity of those who quit work and the cost linked to the possible impoverishment of the worker and her/his family for the years to come.
At present time there are no published studies that investigated these issues in patients with hematological malignancies in the Italian context. This explorative study aims at identifying the main problems that patients of Chronic Hematological Disease (CHD) deal when returning to everyday working life, factors associated with job reintegration and to understand the need for facilitators enhancing reintegration outcomes.
Results from this study will be also helpful in the effort of raising consciousness about the problem of reintegration in 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
- Being tested
- Study questionnaire, SF-36 Questionnaire
- Keywords
- Chronic Hematological Diseases, work, job
- Medical subject headings
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Leukemia, Lymphocytic, Chronic, B-Cell, Myelodysplastic Syndromes, Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study questionnaireBehavioural
Questionnaire based on work situation of enrolled patients.
SF-36 QuestionnaireBehavioural
Version 1.6
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Study questionnaire; Behavioral: SF-36 Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Three months.
Secondary outcomes (3)
Correlation between health status and occupational status.
Evaluated only once during the first outpatient visit in the study time window. Outcome measure is a patient reported outcome (PRO)
Measured: Three months.
Predictors of return to work in patients with a chronic blood disease.
We will test patient data relationship with occupational status in a multivariate analysis.
Measured: Three months.
Proportion of patients needing external support to return to work.
Evaluated only once during the first outpatient visit in the study time window. Outcome measure is a patient reported outcome (PRO)
Measured: Three months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study start8 Sep 2014
- Primary completion11 Nov 2015
- Study completion11 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Adecco per le Pari Opportunità
- Responsible party
- Sponsor
- Investigators
- Edoardo La Sala, Study chair, GIMEMA Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02057185
- Sponsor's protocol ID
- EMATO 0113
- Acronym
- EMATO0113
- Status last verified
- Oct 2020
- First submitted
- 4 Feb 2014
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Status and Hematological Disease: Effects and Counseling Needs
- ClinicalTrials.gov ID
- NCT02057185
- Acronym / sponsor ID
- EMATO0113 / EMATO 0113
- Conditions
- Chronic Myeloid Leukemia, Chronic Lymphocytic Leukemia, Myelodysplastic Syndrome, Chronic Thrombocytopenia, Hodgkin Disease
- Keywords
- Chronic Hematological Diseases, work, job
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Gruppo Italiano Malattie EMatologiche dell'AdultoUniversity, hospital or other
- Collaborators
- Fondazione Adecco per le Pari Opportunità
- Study start
- 8 Sep 2014 (actual)
- Primary completion
- 11 Nov 2015 (actual)
- Study completion
- 11 Nov 2015 (actual)
- First posted
- 6 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A disease doesn't have only a physical side but usually involves changes in the person as whole. It changes the structure of the relationship between a person and his life setting, deeply impacting the way her/he relates to others and to himself. While clinical results of new therapies about hematological pathologies 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.
A number of economists have argued that there is a causal link between increasing inequality and the financial crisis. Evidence from different EU Member States shows that people who declare themselves as being permanently disabled are over-represented among people at risk of poverty or social exclusion compared to the whole population.
In Italy, in the second quarter of 2011, 6 million 556 thousand people aged 15-64 years (16.5% of the population of this age group) claimed to be suffering from one or more longstanding health problems or functional difficulties.
Health problems represent a barrier to the inclusion in the labour market. More than 50% of those suffering from more than one health problem or functional difficulties is inactive, this share decreases significantly among those who complain about one problem or difficulty (39.9%) and no problem (35.5%).
Among persons employed who complain of poor health conditions, about one in 10 may rely on one or more types of assistance in their place of work: availability of special equipment or workplace adaptations, personal service, special working arrangements. Among people who do not have a job, however, more than a quarter (26.6%) would need to receive at least one type of assistance in order to work.
People with long-term illnesses have an higher probability of leaving the workforce at an early age and people who continue to work despite health problems are likely to be less productive than healthy people. Thus, without a timely and appropriate reintegration, they may be less likely to return to work.
In this scenario it's of utmost importance to increase the overall capability to deliver targeted actions in order to be able to support people at risk of social -work exclusion.
Policy instruments being able to provide access to the labour market also play an important role, as well as measures in favor of education. Studies have shown several benefits associated with returning to work after cancer, including addressing financial needs, providing a distraction and an overall improvement in quality of life. Health professionals advice and support and the role of the employers in providing a sound workplace accommodation may play an important role in this regard but, on the other hand, a number of studies show an association between cancer survivorship and risk of unemployment.
The impact of returning to work after (or during) a long-term illness must be evaluated also from the perspective of the family and of the community. It could be very hard for partners and other relatives to conciliate their work duties with the task of taking care of the sick person - in terms of time and of mental strain. While laws usually allow for a number of measures to ease this issue, more information is often needed to workers and to employers.
The cost of a sick worker, from the viewpoint of the community, includes not only the cost of health care and rehabilitation but also the lost productivity of those who quit work and the cost linked to the possible impoverishment of the worker and her/his family for the years to come.
At present time there are no published studies that investigated these issues in patients with hematological malignancies in the Italian context. This explorative study aims at identifying the main problems that patients of Chronic Hematological Disease (CHD) deal when returning to everyday working life, factors associated with job reintegration and to understand the need for facilitators enhancing reintegration outcomes.
Results from this study will be also helpful in the effort of raising consciousness about the problem of reintegration in the labour market of workers with CHD and to call for awareness campaigns for the general public and health professionals.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study population | – | Behavioral: Study questionnaire, Behavioral: SF-36 QuestionnairePatients 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. |
Who may qualify
- Ages
- 15 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a chronic hematological disease aged between 15 and 74 years old fully able to understand Italian.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Not Italian speaking or unable to fully understand the study's forms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study questionnaireQuestionnaire based on work situation of enrolled patients. | Behavioural | Study population |
| SF-36 QuestionnaireVersion 1.6 | Behavioural | Study population |
Primary outcome
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.
3 secondary outcomes
Correlation between health status and occupational status.
Time frame: Three months.
Predictors of return to work in patients with a chronic blood disease.
Time frame: Three months.
Proportion of patients needing external support to return to work.
Time frame: Three months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- GIMEMA FoundationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edoardo La Sala study chair
GIMEMA Foundation
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloid Leukemia and Chronic Lymphocytic Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 6 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who lost their job as a consequence of the disease. (time frame: Three months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024; AzTrials last refreshed its copy on 29 Oct 2026.