Personalized Breast Cancer Screening: Assessment of Its Feasibility and Acceptability in the National Health System
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Institut de Recerca Biomèdica de Lleida
- Enrollment
- 387
- Locations
- 1
- Primary Endpoint
- Satisfaction with personalised screening
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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:
- Prototype information system with basal and longitudinal variables relevant to a personalized screening system;
- Qualitative study with focus groups and survey. The attitude and acceptability on a sample of 210 health professionals will be assessed;
- 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;
- 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.
Investigators
Montserrat Rue
Professor
Institut de Recerca Biomèdica de Lleida
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Satisfaction with personalised screening
Time Frame: At 1 year of the study start
Satisfaction Likert scale with one item that ranges from 1 to 5: not at all satisfied (1), extremely satisfied (5). Following the Sekhon et al. review (2017)
Attitude towards personalised breast cancer screening (by participant women)
Time Frame: 2-4 weeks after being informed of the individual breast cancer risk
Attitude scale with three items, one about the frequency of screening exams (ranges from 1 to 5). The other two items ask if participants are satisfied of being invited more/less frequently, in case that they have a higher/lower risk of breast cancer than the average women. They also range from 1 to 5. Total scores can range from 3 to 15. Higher scores indicate more positive attitudes. A positive attitude is defined as a total score greater or equal to 12. Adapted from Hersch et al. (2015)
Intention to participate in personalised breast cancer screening
Time Frame: 2-4 weeks after being informed of the individual breast cancer risk
Categorical variable with five categories: definitely will, likely to, unsure, not likely to, definitely will not. The absolute and relative frequencies of the five categories will be obtained. In addition, the variable will be dichotomized as intending to participate (definitely or likely) or not. Adapted from Hersch et al. (2015)
Secondary Outcomes
- Screening attitudes scale(2-4 weeks after being informed of the individual breast cancer risk)
- Attitude towards the measure of breast cancer risk(2-4 weeks after being informed of the individual breast cancer risk)
- Emotional impact of the measure of breast cancer risk(2-4 weeks after being informed of the individual breast cancer risk)
- Preference with regard to the current screening, biennial between 50 and 69 years(2-4 weeks after being informed of the individual breast cancer risk)
- Self-efficacy(2-4 weeks after being informed of the individual breast cancer risk)
- Experience assessment(2-4 weeks after being informed of the individual breast cancer risk)
- Time spent on risk communication(At the time of communicating risk, 2-4 weeks after the baseline visit)
- Proportion of women who accept to participate in the study(Through study completion, an average of 1.75 years)
- Knowledge of the benefits and harms of breast cancer screening(2-4 weeks after being informed of the individual breast cancer risk)
- Decisional conflict(2-4 weeks after being informed of the individual breast cancer risk)
- Perceived significance of the benefits and the adverse effects of screening(2-4 weeks after being informed of the individual breast cancer risk)
- Understanding of the individual risk and the screening recommendations(2-4 weeks after being informed of the individual breast cancer risk)
- Confidence in the decision(2-4 weeks after being informed of the individual breast cancer risk)
- Anxiety about screening participation(2-4 weeks after being informed of the individual breast cancer risk)
- Confidence in personalised screening(2-4 weeks after being informed of the individual breast cancer risk)
- Proportion of participating women who complete the different phases of the study(Through study completion, an average of 1.75 years)