Clinical trial · Interventional
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
- 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)
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
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Risk based screening | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Attitude towards personalised breast cancer screening (by participant women)
- timeFrame
- 2-4 weeks after being informed of the individual breast cancer risk
- description
- 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)
- measure
- Intention to participate in personalised breast cancer screening
- timeFrame
- 2-4 weeks after being informed of the individual breast cancer risk
- description
- 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)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (3)
- BACKGROUNDHersch J, Barratt A, Jansen J, Irwig L, McGeechan K, Jacklyn G, Thornton H, Dhillon H, Houssami N, McCaffery K. Use of a decision aid including information on overdetection to support informed choice about breast cancer screening: a randomised controlled trial. Lancet. 2015 Apr 25;385(9978):1642-52. doi: 10.1016/S0140-6736(15)60123-4. Epub 2015 Feb 18. PMID 25701273
- BACKGROUNDSekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8. PMID 28126032
- DERIVEDPons-Rodriguez A, Forne Izquierdo C, Vilaplana-Mayoral J, Cruz-Esteve I, Sanchez-Lopez I, Rene-Rene M, Cazorla C, Hernandez-Andreu M, Galindo-Ortego G, Llorens Gabande M, Laza-Vasquez C, Balaguer-Llaquet P, Martinez-Alonso M, Rue M; DECIDO Group. Feasibility and acceptability of personalised breast cancer screening (DECIDO study): protocol of a single-arm proof-of-concept trial. BMJ Open. 2020 Dec 23;10(12):e044597. doi: 10.1136/bmjopen-2020-044597. PMID 33361170