Clinical trial · Observational
Breast Cancer Risk Assessment in Night Shift Workers - Implementation of a Personalized Consultation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates adherence to a personalized prevention plan in female night shift workers at increased risk of breast cancer. Night shift work is associated with circadian disruption and increased cancer risk, as well as cardiovascular and reproductive health risks. Participants attend an initial consultation including clinical assessment and development of a personalized prevention plan targeting modifiable risk factors such as alcohol consumption, physical activity, smoking, diet, and weight. Follow-up is conducted remotely over 5 years to assess adherence to recommendations and screening. Participant satisfaction and adherence to additional consultations are also evaluated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms Diagnosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Personalized Prevention Plan | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Participants with Personalized Prevention Plan
- description
- Participants receive a tailored prevention plan following risk assessment
- interventionNames
- Behavioral: Personalized Prevention Plan
Primary outcomes (1)
- measure
- Adherence to Personalized Prevention Plan established during the initial risk assessment consultation
- timeFrame
- At 1, 2, 3 and 5 years.
- description
- Proportion of participants adhering to at least one recommendation of the Personalized Prevention Plan or completing prescribed screening. Percentage of participants who lost weight when overweight had been identified during the initial consultation. Percentage of participants with modified sporting activity according to the recommendations at the initial consultation. Percentage of participants who had quit smoking. Percentage of participants who modified their alcohol consumption when it was excessive at the initial consultation. Percentage of participants who changed their diets when a dietary imbalance was observed during the initial consultation. Percentage of women who underwent screening as recommended following the initial consultation.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female participants aged 18 years or older * Night shift workers at Pitié-Salpêtrière Hospital * Attending consultation for breast cancer risk assessment PGRC * Affiliated with a social security system * No personal history of breast cancer * Provided informed consent (non-opposition procedure according to French regulations) Exclusion Criteria: * Pregnant or breastfeeding women * Individuals under legal protection or deprived of liberty * Individuals without standard health insurance coverage
References
Publications (0)
Data not yet available