An observational study in Inflammatory Bowel Diseases (IBD), Crohn Disease and Ulcerative Colitis (UC), sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Active, not recruiting at 2 sites in Italy. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Observational
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.
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.
1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 438 are open to participants now.
This study's planned enrollment of 200 is above the median of 139 across 645 observational studies indexed under Inflammatory Bowel Diseases.
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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.
Exclusion Criteria
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.
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.
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.
Time frame: Baseline and 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: Baseline and 12 months
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS