Assessment of Feasibility and Acceptability of Personalized Breast Cancer Screening
NCT ID: NCT03791008
Last Updated: 2022-03-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
387 participants
INTERVENTIONAL
2019-01-30
2021-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Interventions
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Risk based screening
Breast cancer risk measurement, screening recommendations and shared decision making
Eligibility Criteria
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Inclusion Criteria
* Sign the informed consent.
Exclusion Criteria
* 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.
40 Years
50 Years
FEMALE
Yes
Sponsors
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Institut Català de la Salut
OTHER
Catalan Health Service
UNKNOWN
Institut de Recerca Biomèdica de Lleida
OTHER
Responsible Party
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Montserrat Rue
Professor
Locations
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Institut de Recerca Biomèdica de Lleida
Lleida, , Spain
Countries
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References
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Hersch 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.
Sekhon 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.
Pons-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.
Other Identifiers
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PI17/00834
Identifier Type: -
Identifier Source: org_study_id
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