Clinical trial NCT03791008: Assessment of Feasibility and Acceptability of Personalized Breast Cancer Screening
Official title: Personalized Breast Cancer Screening: Assessment of Its Feasibility and Acceptability in the National Health System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: Personalized
Early detection
Screening
Feasibility
Acceptability
Lead sponsor: Institut de Recerca Biomèdica de Lleida
Sponsor class: OTHER
Collaborators: name: Institut Català de la Salut
name: Catalan Health Service
First posted: 2019-01-02
Enrollment: 387
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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:

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.


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.

Primary outcomes:
measure: Attitude towards personalised breast cancer screening (by participant women)
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Intention to participate in personalised breast cancer screening
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Satisfaction with personalised screening
timeFrame: At 1 year of the study start
Secondary outcomes:
measure: Screening attitudes scale
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Attitude towards the measure of breast cancer risk
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Emotional impact of the measure of breast cancer risk
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Preference with regard to the current screening, biennial between 50 and 69 years
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Knowledge of the benefits and harms of breast cancer screening
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Decisional conflict
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Confidence in the decision
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Anxiety about screening participation
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Perceived significance of the benefits and the adverse effects of screening
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Self-efficacy
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Experience assessment
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Confidence in personalised screening
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Understanding of the individual risk and the screening recommendations
timeFrame: 2-4 weeks after being informed of the individual breast cancer risk
measure: Time spent on risk communication
timeFrame: At the time of communicating risk, 2-4 weeks after the baseline visit
measure: Proportion of women who accept to participate in the study
timeFrame: Through study completion, an average of 1.75 years
measure: Proportion of participating women who complete the different phases of the study
timeFrame: Through study completion, an average of 1.75 years
Other outcomes:
Locations:
city: Lleida
country: Spain
facility: Institut de Recerca Biomèdica de Lleida
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.