Assessment of Feasibility and Acceptability of Personalized Breast Cancer Screening (DECIDO)

Institut de Recerca Biomèdica de Lleida

Status: Completed

Conditions: Breast Cancer

Treatments: Other: Risk based screening

Study type: Interventional

Funder types: Other

Identifiers

NCT03791008

PI17/00834

Details and patient eligibility

About

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.

Enrollment: 387 patients

Sex: Female

Ages: 40 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Not having had a mammogram in the last 12 months or with a mammogram in this period available to evaluate breast density.
• Sign the informed consent.

Exclusion criteria

• Previous diagnosis of breast cancer.
• Breast study in process.
• Fulfill clinical criteria defined by the Medical Oncology Spanish Society (SEOM to refer to the genetic counseling unit in cancer.
• Do not understand or speak Catalan or Spanish.
• Cognitive disability for mental or mental illness.
• Physical disability that prevents a mammogram.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)