Assessment of Feasibility and Acceptability of Personalized Breast Cancer Screening

NCT03791008 | Completed

• 1 other identifier: PI17/00834
• Study Type: interventional
• Target: 387
• Locations: 1 country
• Sites: 1

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. 1.Prototype information system with basal and longitudinal variables relevant to a personalized screening system;
2. 2.Qualitative study with focus groups and survey. The attitude and acceptability on a sample of 210 health professionals will be assessed;
3. 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. 4.Probabilistic analytical models will be used to evaluate cost-effectiveness.

Conditions

Breast Cancer

Keywords

Personalized; Early detection; Screening; Feasibility; Acceptability

Outcome Measures

Primary Outcomes (3)

• Attitude towards personalised breast cancer screening (by participant women)

  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)

  2-4 weeks after being informed of the individual breast cancer risk

• Intention to participate in personalised breast cancer screening

  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)

  2-4 weeks after being informed of the individual breast cancer risk

• Satisfaction with personalised screening

  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)

  At 1 year of the study start

Secondary Outcomes (16)

• 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

• Knowledge of the benefits and harms of breast cancer screening

  2-4 weeks after being informed of the individual breast cancer risk

Interventions

Risk based screening OTHER

Breast cancer risk measurement, screening recommendations and shared decision making

Eligibility Criteria

• Age: 40 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Recerca Biomèdica de Lleida: lead
• Institut Català de la Salut: collaborator
• Catalan Health Service: collaborator

Study Sites (1)

Institut de Recerca Biomèdica de Lleida

Lleida, 25198, Spain

Location

Related Publications (3)

• 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.

  PMID: 25701273 BACKGROUND

• 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.

  PMID: 28126032 BACKGROUND

• 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.

  PMID: 33361170 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: January 2, 2019
• Study Start: January 30, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

ES (1)