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Assessment of Feasibility and Acceptability of Personalized Breast Cancer Screening

NCT03791008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 387

Last updated 2022-03-31

No results posted yet for this study

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

Interventions

OTHER

Risk based screening

Breast cancer risk measurement, screening recommendations and shared decision making

Sponsors & Collaborators

  • Institut Català de la Salut

    collaborator OTHER

  • Catalan Health Service

    collaborator UNKNOWN

  • Institut de Recerca Biomèdica de Lleida

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-30
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03791008 on ClinicalTrials.gov