NCT03791008

Assessment of Feasibility and Acceptability of Personalized Breast Cancer Screening

Personalized Breast Cancer Screening: Assessment of Its Feasibility and Acceptability in the National Health System

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: Institut de Recerca Biomèdica de Lleida · Academic / Other
• Sex: Female
• Age: 40 Years – 50 Years
• Healthy volunteers: Accepted

Summary

The overall objective is to assess the acceptability and feasibility of offering personalized breast cancer (BC) screening. The specific objectives are: 1) To design an information system; 2) To evaluate the barriers and facilitators of the coordination of health care services and the screening program; 3) To develop a proof of concept of personalized screening; and 4) To evaluate cost-effectiveness. Methodology: 1. Prototype information system with basal and longitudinal variables relevant to a personalized screening system; 2. Qualitative study with focus groups and survey. The attitude and acceptability on a sample of 210 health professionals will be assessed; 3. Prospective observational study, for proof of concept. Participants will be professionals working in Primary Care, Population Breast Screening Program, or Hospital Breast Unit. It will include 385 women, aged 40-50 from the city of Lleida. Various indicators of acceptability and feasibility will be assessed in women and health professionals; 4. Probabilistic analytical models will be used to evaluate cost-effectiveness. The present protocol addresses the specific objective number 3, the proof of concept of personalised screening. Expected results: The investigators expect to provide valuable and necessary information for the design of personalized screening.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
OTHER	Risk based screening	Breast cancer risk measurement, screening recommendations and shared decision making

Timeline

• Start date: 2019-01-30
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-01-02
• Last updated: 2022-03-31

Locations

1 site across 1 country: Spain