Integrated Clinical-Occupational Management for Workers With Chronic Noncommunicable Diseases

NCT07694609 | Active Not Recruiting

• 1 other identifier: 27483
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Inflammatory Bowel Diseases (IBD); Crohn Disease; Ulcerative Colitis (UC)

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12 months

Secondary Outcomes (9)

• Change in Inflammatory Bowel Disease Activity From Baseline to 12 Months

  Baseline and 12 months

• Breast Cancer Clinical and Pathological Profile

  Baseline and 12 months

• Change in Functioning, Disability, and Work Participation From Baseline to 12 Months

  Baseline and 12 months

• Change in Work Productivity and Activity Impairment From Baseline to 12 Months

  Baseline and 12 months

• Change in Worker Well-Being From Baseline to 12 Months

  Baseline and 12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, RM, 00168, Italy

Location

Università degli Studi di Napoli Federico II

Naples, 80131, Italy

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Study Officials

• Ivo Iavicoli

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 10, 2026
• Study Start: April 23, 2026
• Primary Completion (Estimated): October 23, 2027
• Study Completion (Estimated): April 23, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

IT (2)