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Study aims to keep workers with chronic illnesses on the job

NCT ID NCT07694609

Knowledge-focused Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This study looks at how chronic noncommunicable diseases like inflammatory bowel disease and breast cancer impact a person's ability to work. Researchers will follow 200 working-age adults for 12 months, collecting data on health, work performance, and well-being. The goal is to design a care pathway that combines medical and occupational support to help people stay employed or return to work safely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to an integrated care pathway that helps workers with chronic diseases stay employed and return to work safely.
What could go wrong
This is an observational study, so it does not test a treatment. The findings may not apply to all workers or diseases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria * 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.

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Conditions

The condition(s) this trial relates to.

breast cancer Crohn disease inflammatory bowel disease ulcerative colitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease Inflammatory bowel diseases (IBD) Ulcerative colitis (UC)

Contacts and locations

Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Rome, RM, 00168, Italy

  • Università degli Studi di Napoli Federico II

    Naples, 80131, Italy

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