Evaluation of an Integrated Clinical-Occupational Management Pathway for the Global Health Protection of Workers With Chronic Noncommunicable Diseases
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Change in Work Ability Index (WAI) Score From Baseline to 12 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Work Ability Index (WAI) Score From Baseline to 12 Months
时间窗: 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.
次要结局
- 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)
- Change in Health-Related Quality of Life From Baseline to 12 Months(Baseline and 12 months)
- Change in Depression, Anxiety, and Stress Symptoms From Baseline to 12 Months(Baseline and 12 months)
- Change in Psychological Well-Being From Baseline to 12 Months(Baseline and 12 months)
- Change in Fatigue From Baseline to 12 Months(Baseline and 12 months)