Inflammatory Bowel Diseases (IBD)MCNT@WORKNCT07694609
Integrated Clinical-Occupational Management for Workers With Chronic Noncommunicable Diseases
An observational study of Inflammatory Bowel Diseases (IBD) and Crohn Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
Trial summary
MCNT@WORK is a prospective multicenter observational study assessing how chronic noncommunicable diseases affect work ability, quality of life, psychological well-being, and occupational participation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Inflammatory Bowel Diseases (IBD), Crohn Disease, Ulcerative Colitis (UC)
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 23 Apr 2026to 23 Apr 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study participants will be selected from working-age adult patients receiving care at the participating clinical units of Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Patients with breast cancer will be recruited from the Breast Surgery Unit, while patients with inflammatory bowel disease, including Crohn's disease and ulcerative colitis, will be recruited from the Digestive Disease Center Unit. The study is expected to include at least 200 participants: approximately 100 patients with breast cancer and approximately 100 patients with inflammatory bowel disease. The Occupational Medicine Unit will be involved in the integrated clinical-occupational assessment and management pathway, in collaboration with the clinical specialist units.
Who may be able to join
- Age ≥18 years and <70 years.
- Confirmed diagnosis of inflammatory bowel disease, including Crohn's disease or ulcerative colitis, or confirmed diagnosis of breast cancer.
- Patient under care at one of the participating clinical units.
- For patients with breast cancer: inclusion from diagnosis, during preparation for surgery or neoadjuvant chemotherapy, or during post-treatment follow-up.
- For patients with inflammatory bowel disease: confirmed diagnosis at any clinical stage and regardless of ongoing treatment.
- Ability to understand the aims of the study and to complete the questionnaires required by the protocol.
- Written informed consent to participate in the study and to the processing of personal data according to Regulation (EU) 2016/679 - GDPR.
Who cannot join
- Age <18 years or >70 years.
- Absence of a confirmed diagnosis of inflammatory bowel disease, including Crohn's disease or ulcerative colitis, or breast cancer.
- Acute clinical conditions or severe comorbidities that, in the opinion of the responsible physician, prevent participation in the study or correct completion of the assessment tools.
- Cognitive, linguistic, or psychiatric impairment affecting the ability to understand the information provided or to complete the questionnaires required by the protocol.
- Failure to provide written informed consent or refusal of personal data processing according to Regulation (EU) 2016/679 - GDPR.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Università degli Studi di Napoli Federico II
Naples, 80131
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, RM, 00168
About this study
Official title: Evaluation of an Integrated Clinical-Occupational Management Pathway for the Global Health Protection of Workers With Chronic Noncommunicable Diseases
MCNT@WORK is a prospective multicenter observational study assessing how chronic noncommunicable diseases affect work ability, quality of life, psychological well-being, and occupational participation. It will enroll at least 200 working-age adults with inflammatory bowel disease or breast cancer, assessed at baseline and after 12 months. The study will collect clinical, functional, psychological, social, and occupational data to identify factors linked to reduced work ability, absenteeism, presenteeism, return-to-work barriers, or early labor-market exit. Findings will support an integrated clinical-occupational care pathway, combining specialist care and occupational medicine. The goal is to promote personalized support, safe return to work, job retention, and sustainable employment.
Read the detailed description
MCNT@WORK is a prospective, multicenter observational study designed to evaluate the impact of chronic noncommunicable diseases on work ability, quality of life, psychological well-being, and occupational participation in working-age adults. The study will enroll at least 200 adult participants, including 100 patients with inflammatory bowel diseases, defined as Crohn's disease or ulcerative colitis, and 100 patients with breast cancer. Participants will be recruited from the participating clinical units and will undergo a baseline assessment at enrollment and a follow-up assessment after 12 months. At baseline, the study will collect integrated socio-demographic, clinical, functional, psychological, and occupational information. The assessment will include disease-related characteristics, treatments, functional limitations, work status, job characteristics, occupational exposures or work-related risks, perceived work limitations, quality of life, fatigue, perceived stress, anxiety, depression, work ability, work participation, absenteeism, presenteeism, and productivity. The same domains will be reassessed at 12 months in order to describe changes over time and to identify clinical, psychological, social, and occupational factors associated with reduced work ability, impaired well-being, work absence, barriers to return to work, or risk of early exit from the labor market. The study addresses two chronic disease populations in which work participation may be affected by disease activity, treatment burden, fatigue, psychological distress, functional limitations, and workplace-related factors. For patients with inflammatory bowel disease, the study will consider the impact of disease symptoms, disease activity, extraintestinal manifestations, treatment pathways, and quality of life on work functioning. For patients with breast cancer, the study will explore the occupational impact of diagnosis, surgery, systemic treatments, fatigue, upper-limb morbidity, psychological burden, and the process of return to work during or after treatment.
Based on the multidimensional assessment, the study aims to develop and implement an integrated clinical-occupational management pathway for workers with chronic diseases. This pathway will combine specialist clinical care and occupational medicine and may include lifestyle counseling, psychological support, evidence-based non-pharmacological strategies, social prescribing, workplace health and safety recommendations, reasonable accommodations, job or task adaptations, and strategies to support job retention or return to work. The study will also support the development of practical tools for multidisciplinary assessment and management, such as integrated clinical-occupational evaluation forms, operational checklists, decision-support pathways, and recommendations for personalized risk management. These tools are intended to help clinicians, occupational physicians, and other stakeholders identify work-related needs, define appropriate support measures, and promote safe and sustainable employment.
The overall goal of the study is to generate evidence and operational recommendations for a personalized, multidisciplinary approach to the management of workers with inflammatory bowel disease or breast cancer. By integrating clinical, psychological, social, and occupational dimensions, MCNT@WORK aims to support global health, quality of life, work ability, work participation, job retention, and safe return to work among people living with chronic diseases.
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Inflammatory Bowel Disease Cohort | Working-age adult patients with a confirmed diagnosis of inflammatory bowel disease, including Crohn's disease or ulcerative colitis, recruited from the participating gastroenterology unit. Patients may be included at any clinical stage and regardless of ongoing treatment. | |
| Breast Cancer Cohort | Working-age adult patients with a confirmed diagnosis of breast cancer, recruited from the participating breast surgery unit. Patients may be included from diagnosis, during preparation for surgery or neoadjuvant chemotherapy, or during post-treatment follow-up. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Work Ability Index (WAI) Score From Baseline to 12 Months
Work ability will be assessed using the Work Ability Index (WAI), a standardized and validated questionnaire evaluating the worker's perceived ability to work in relation to job demands, health status, diagnosed diseases, sickness absence, future work ability expectations, and psychological resources. The total WAI score ranges from 7 to 49, with higher scores indicating better work ability. Change in WAI score will be assessed by comparing baseline values with values collected at the 12-month follow-up.
Measured: Baseline and 12 months
Secondary outcomes (9)
Change in Inflammatory Bowel Disease Activity From Baseline to 12 Months
Disease activity in participants with inflammatory bowel disease will be assessed using validated clinical indices. Crohn's disease activity will be evaluated using the Crohn's Disease Activity Index (CDAI), which combines patient-reported symptoms, clinical findings, and laboratory parameters collected over 7 days. The CDAI score generally ranges from 0 to 600, with higher scores indicating greater disease activity. Ulcerative colitis activity will be evaluated using the Mayo Score, which includes stool frequency, rectal bleeding, endoscopic findings, and physician global assessment. The Mayo Score ranges from 0 to 12, with higher scores indicating greater inflammatory activity.
Measured: Baseline and 12 months
Breast Cancer Clinical and Pathological Profile
The clinical and pathological profile of participants with breast cancer will be described using tumor staging, histological grading, and molecular classification. Tumor stage will be assessed according to the TNM classification, which evaluates tumor size and local extension, regional lymph node involvement, and distant metastases. Histological grading will be assessed using the Nottingham system, based on tubular formation, nuclear pleomorphism, and mitotic index. Molecular classification will be based on biological markers including estrogen receptor, progesterone receptor, HER2 status, and Ki-67, allowing classification into clinically relevant breast cancer subtypes.
Measured: Baseline and 12 months
Change in Functioning, Disability, and Work Participation From Baseline to 12 Months
Functioning, disability, and work participation will be assessed using the International Classification of Functioning, Disability and Health (ICF). The ICF provides a multidimensional framework to describe body functions and structures, activities and participation, and contextual factors, including environmental and personal factors. In this study, the ICF will be used to identify functional limitations, restrictions in work-related activities, and environmental barriers or facilitators relevant to job retention and return to work.
Measured: Baseline and 12 months
Change in Work Productivity and Activity Impairment From Baseline to 12 Months
Work productivity and activity impairment will be assessed using the Work Productivity and Activity Impairment Questionnaire (WPAI). The WPAI-General Health version will be used for participants with breast cancer, while the WPAI-Specific Health Problem version will be used for participants with inflammatory bowel disease. The WPAI evaluates employment status, hours missed from work, hours worked, impairment while working, overall work productivity loss, and activity impairment over the previous 7 days. Results are expressed as percentages, with higher values indicating greater impairment.
Measured: Baseline and 12 months
Change in Worker Well-Being From Baseline to 12 Months
Worker well-being will be assessed using the NIOSH Worker Well-Being Questionnaire (NIOSH WellBQ), in the validated Italian version. The questionnaire evaluates worker well-being from a holistic perspective across five domains: work evaluation and experience, workplace policies and culture, workplace physical environment and safety climate, health status, and home, community, and society. The instrument includes 126 items and provides domain-specific indices and scales; it does not provide clinical diagnostic cut-offs.
Measured: Baseline and 12 months
Change in Health-Related Quality of Life From Baseline to 12 Months
Health-related quality of life will be assessed using the Medical Outcomes Study Short Form-36 Health Survey (SF-36). The SF-36 is a 36-item self-administered questionnaire assessing eight domains: physical functioning, role limitations due to physical health, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional problems, and mental health. Scores are transformed on a 0 to 100 scale, with higher scores indicating better perceived quality of life. Physical and mental component summary scores may also be calculated.
Measured: Baseline and 12 months
Change in Depression, Anxiety, and Stress Symptoms From Baseline to 12 Months
Depression, anxiety, and stress symptoms will be assessed using the Depression Anxiety Stress Scales-21 items (DASS-21). The DASS-21 is a self-report psychometric instrument composed of 21 items divided into three 7-item subscales assessing depression, anxiety, and stress. Each item is rated on a 4-point Likert scale according to symptom frequency during the previous week, with higher scores indicating greater symptom severity.
Measured: Baseline and 12 months
Change in Psychological Well-Being From Baseline to 12 Months
Psychological well-being will be assessed using the Psychological General Well-Being Index (PGWBI). The PGWBI is a 22-item questionnaire evaluating perceived emotional and psychological well-being over the previous 4 weeks. It includes six dimensions: anxiety, depression, positive well-being, self-control, general health, and vitality. The total score ranges from 0 to 110, with higher scores indicating better psychological well-being
Measured: Baseline and 12 months
Change in Fatigue From Baseline to 12 Months
Fatigue will be assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue). The FACIT-Fatigue is a standardized and validated 13-item patient-reported outcome measure evaluating fatigue intensity, energy level, ability to perform daily, work, and social activities, and the impact of fatigue on physical and psychological well-being during the previous 7 days. The total score ranges from 0 to 52, with higher scores indicating lower fatigue severity and better global functioning.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start23 Apr 2026
- Primary completion23 Oct 2027 (estimated)
- Study completion23 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel Diseases (IBD)Studies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ivo Iavicoli, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694609
- Sponsor's protocol ID
- 27483
- Acronym
- MCNT@WORK
- Status last verified
- Jul 2026
- First submitted
- 3 Jul 2026
- Last updated
- 10 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Integrated Clinical-Occupational Management Pathway for the Global Health Protection of Workers With Chronic Noncommunicable Diseases
- ClinicalTrials.gov ID
- NCT07694609
- Acronym / sponsor ID
- MCNT@WORK / 27483
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 23 Apr 2026 (actual)
- Primary completion
- 23 Oct 2027 (estimated)
- Study completion
- 23 Apr 2028 (estimated)
- First posted
- 10 Jul 2026 (actual)
- 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.
MCNT@WORK is a prospective multicenter observational study assessing how chronic noncommunicable diseases affect work ability, quality of life, psychological well-being, and occupational participation. It will enroll at least 200 working-age adults with inflammatory bowel disease or breast cancer, assessed at baseline and after 12 months. The study will collect clinical, functional, psychological, social, and occupational data to identify factors linked to reduced work ability, absenteeism, presenteeism, return-to-work barriers, or early labor-market exit. Findings will support an integrated clinical-occupational care pathway, combining specialist care and occupational medicine. The goal is to promote personalized support, safe return to work, job retention, and sustainable employment.
Detailed description
MCNT@WORK is a prospective, multicenter observational study designed to evaluate the impact of chronic noncommunicable diseases on work ability, quality of life, psychological well-being, and occupational participation in working-age adults. The study will enroll at least 200 adult participants, including 100 patients with inflammatory bowel diseases, defined as Crohn's disease or ulcerative colitis, and 100 patients with breast cancer. Participants will be recruited from the participating clinical units and will undergo a baseline assessment at enrollment and a follow-up assessment after 12 months. At baseline, the study will collect integrated socio-demographic, clinical, functional, psychological, and occupational information. The assessment will include disease-related characteristics, treatments, functional limitations, work status, job characteristics, occupational exposures or work-related risks, perceived work limitations, quality of life, fatigue, perceived stress, anxiety, depression, work ability, work participation, absenteeism, presenteeism, and productivity. The same domains will be reassessed at 12 months in order to describe changes over time and to identify clinical, psychological, social, and occupational factors associated with reduced work ability, impaired well-being, work absence, barriers to return to work, or risk of early exit from the labor market. The study addresses two chronic disease populations in which work participation may be affected by disease activity, treatment burden, fatigue, psychological distress, functional limitations, and workplace-related factors. For patients with inflammatory bowel disease, the study will consider the impact of disease symptoms, disease activity, extraintestinal manifestations, treatment pathways, and quality of life on work functioning. For patients with breast cancer, the study will explore the occupational impact of diagnosis, surgery, systemic treatments, fatigue, upper-limb morbidity, psychological burden, and the process of return to work during or after treatment.
Based on the multidimensional assessment, the study aims to develop and implement an integrated clinical-occupational management pathway for workers with chronic diseases. This pathway will combine specialist clinical care and occupational medicine and may include lifestyle counseling, psychological support, evidence-based non-pharmacological strategies, social prescribing, workplace health and safety recommendations, reasonable accommodations, job or task adaptations, and strategies to support job retention or return to work. The study will also support the development of practical tools for multidisciplinary assessment and management, such as integrated clinical-occupational evaluation forms, operational checklists, decision-support pathways, and recommendations for personalized risk management. These tools are intended to help clinicians, occupational physicians, and other stakeholders identify work-related needs, define appropriate support measures, and promote safe and sustainable employment.
The overall goal of the study is to generate evidence and operational recommendations for a personalized, multidisciplinary approach to the management of workers with inflammatory bowel disease or breast cancer. By integrating clinical, psychological, social, and occupational dimensions, MCNT@WORK aims to support global health, quality of life, work ability, work participation, job retention, and safe return to work among people living with chronic diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease Cohort | – | –Working-age adult patients with a confirmed diagnosis of inflammatory bowel disease, including Crohn's disease or ulcerative colitis, recruited from the participating gastroenterology unit. Patients may be included at any clinical stage and regardless of ongoing treatment. |
| Breast Cancer Cohort | – | –Working-age adult patients with a confirmed diagnosis of breast cancer, recruited from the participating breast surgery unit. Patients may be included from diagnosis, during preparation for surgery or neoadjuvant chemotherapy, or during post-treatment follow-up. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be selected from working-age adult patients receiving care at the participating clinical units of Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Patients with breast cancer will be recruited from the Breast Surgery Unit, while patients with inflammatory bowel disease, including Crohn's disease and ulcerative colitis, will be recruited from the Digestive Disease Center Unit. The study is expected to include at least 200 participants: approximately 100 patients with breast cancer and approximately 100 patients with inflammatory bowel disease. The Occupational Medicine Unit will be involved in the integrated clinical-occupational assessment and management pathway, in collaboration with the clinical specialist units.
Key inclusion criteria (7 listed)
- Age ≥18 years and <70 years.
- Confirmed diagnosis of inflammatory bowel disease, including Crohn's disease or ulcerative colitis, or confirmed diagnosis of breast cancer.
- Patient under care at one of the participating clinical units.
- For patients with breast cancer: inclusion from diagnosis, during preparation for surgery or neoadjuvant chemotherapy, or during post-treatment follow-up.
- For patients with inflammatory bowel disease: confirmed diagnosis at any clinical stage and regardless of ongoing treatment.
Key exclusion criteria (5 listed)
- Age <18 years or >70 years.
- Absence of a confirmed diagnosis of inflammatory bowel disease, including Crohn's disease or ulcerative colitis, or breast cancer.
- Acute clinical conditions or severe comorbidities that, in the opinion of the responsible physician, prevent participation in the study or correct completion of the assessment tools.
- Cognitive, linguistic, or psychiatric impairment affecting the ability to understand the information provided or to complete the questionnaires required by the protocol.
- Failure to provide written informed consent or refusal of personal data processing according to Regulation (EU) 2016/679 - GDPR.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Work Ability Index (WAI) Score From Baseline to 12 Months
Time frame: Baseline and 12 months
Work ability will be assessed using the Work Ability Index (WAI), a standardized and validated questionnaire evaluating the worker's perceived ability to work in relation to job demands, health status, diagnosed diseases, sickness absence, future work ability expectations, and psychological resources. The total WAI score ranges from 7 to 49, with higher scores indicating better work ability. Change in WAI score will be assessed by comparing baseline values with values collected at the 12-month follow-up.
9 secondary outcomes
Change in Inflammatory Bowel Disease Activity From Baseline to 12 Months
Time frame: Baseline and 12 months
Breast Cancer Clinical and Pathological Profile
Time frame: Baseline and 12 months
Change in Functioning, Disability, and Work Participation From Baseline to 12 Months
Time frame: Baseline and 12 months
Change in Work Productivity and Activity Impairment From Baseline to 12 Months
Time frame: Baseline and 12 months
Change in Worker Well-Being From Baseline to 12 Months
Time frame: Baseline and 12 months
Change in Health-Related Quality of Life From Baseline to 12 Months
Time frame: Baseline and 12 months
Change in Depression, Anxiety, and Stress Symptoms From Baseline to 12 Months
Time frame: Baseline and 12 months
Change in Psychological Well-Being From Baseline to 12 Months
Time frame: Baseline and 12 months
Change in Fatigue From Baseline to 12 Months
Time frame: Baseline and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
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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.
Ivo Iavicoli principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases (IBD) and Crohn Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 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 7 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
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?
Change in Work Ability Index (WAI) Score From Baseline to 12 Months (time frame: Baseline and 12 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 10 Jul 2026.