The Effect of a Patient Decision Aids for Breast Cancer Screening

NCT04948983 | Unknown

• 1 other identifier: SA18i0002
• Study Type: interventional
• Target: 3,269
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is one of the most common cancers in Chile. National efforts focus on early detection, offering universal access to breast cancer screening through mammography to women at risk age. However, 30% of women do not undertake the exam due to a lack of knowledge and anxiety when facing the decision. The aim of this study is to develop and evaluate the effectiveness of a decision aid (DA) for women facing breast cancer screening decision in the country. Methods: following the Medical Research Council guidelines for the development and implementation of a complex intervention in public health, the investigators have: 1) culturally adapted the German DA for mammography; 2) conducted focus groups with experts to further develop the DA; 3) pilot-tested the online DA with 20 women in primary care centres. A total of 3,269 women aged 50 to 69 years old are invited to join the study. The intervention group accesses a webpage, answers a set of questionnaires at baseline, and then the DA (developed according to the IPDAS recommendations). The Control group accesses a webpage, answers a set of questionnaires at baseline, and then receives standardised information given by the healthcare system. Both groups complete the questionnaires two weeks later. The primary outcome measure is an adapted and validated version of Informed Choice. Additionally, decisional conflict, anxiety, and screening undertake rate are measured. Multiple lineal regression analysis will be conducted.

Conditions

Breast Cancer; Mammary Cancer; Breast Tumor; Mammary Tumor

Keywords

Breast Cancer; Decision aid; Decision making process; Mammography; Breast Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Informed choice for breast cancer screening

  An adapted and validated version of the informed choice questionnaire will be used: this is a five-item questionnaire to measure informed choice (Bravo P, Dois A, Fernández-González L, Hernández-Leal MJ, Villarroel L. \[Validation of the Informed Choice instrument for Chilean women facing a mammography decision in primary care\]. Aten Primaria. 2021 Mar;53(3):101943. doi: 10.1016/j.aprim.2020.08.005. Epub 2021 Feb 13. Spanish. PubMed ID: 33592532). Minimum value= 5 Maximum value= 25

  Change from baseline informed choice at two weeks

Secondary Outcomes (4)

• Decisional conflict

  Change from baseline decisional conflict at two weeks

• Depression, anxiety and stress

  Change from baseline drepression, anxiety and stress at two weeks

• Satisfaction with the decision

  Change from baseline satisfaction with the decision at two weeks

• Number of participants who undertake a mammography

  At 6 months

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

The intervention group will access a web page, answer a set of questionnaires at baseline, and then the DA (developed according to the IPDAS recommendations). The intervention group will complete the same questionnaires two weeks later. Six months later we will confirm if the screening was undertaken by checking medical records. The online DA for breast cancer screening is a web-based education material to inform women about the benefits and risks associated with the screening. The contents of the DA are: 1) Assessing breast cancer; 2) What is breast cancer screening?; 3) What will happen if I diagnosed with breast cancer?; 4) What is overdiagnosis?; 5) What is false positive?; 6) the statistics of breast cancer screening; 7) Now is my turn, do I want to take it?

Other: Decision aid (DA) for breast cancer screening

Control group

PLACEBO COMPARATOR

The Control group will access a webpage, answer a set of questionnaires at baseline, and then receive standardised information given by the healthcare system. The control group will complete the same questionnaires two weeks later, afterwards they will access the DA. Six months later we will confirm if the screening was undertaken by checking medical records.

Other: Standarised information for breast cancer screening

Interventions

Decision aid (DA) for breast cancer screening OTHER

The online DA for breast cancer screening is a web-based education material to inform women about the benefits and risks associated with the screening. The contents of the DA are: 1) Assessing breast cancer; 2) What is breast cancer screening?; 3) What will happen if I diagnosed with breast cancer?; 4) What is overdiagnosis?; 5) What is false positive?; 6) the statistics of breast cancer screening; 7) Now is my turn, do I want to take it?

Intervention group

Standarised information for breast cancer screening OTHER

Information provided by the Chilean Ministry of Health in regards to access to breast cancer screening (Age, frequency and costs)

Control group

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women from 50 to 69 years old
• Attend the primary care centres
• Fluent in Spanish

You may not qualify if:

• Women with a personal history of breast cancer
• Have a current mammogram (as recommended by the Chilean Ministry of Health)
• Not having the capacity to consent.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead
• Comisión Nacional de Investigación Científica y Tecnológica: collaborator

Study Sites (1)

Alejandra Martínez

Santiago, sANTIAGO, Chile

RECRUITING

Related Publications (2)

• Bravo P, Dois A, Fernandez-Gonzalez L, Hernandez-Leal MJ, Villarroel L. [Validation of the Informed Choice instrument for Chilean women facing a mammography decision in primary care]. Aten Primaria. 2021 Mar;53(3):101943. doi: 10.1016/j.aprim.2020.08.005. Epub 2021 Feb 13. Spanish.

  PMID: 33592532 RESULT

• Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, Alarcon-Ruiz CA, Kopitowski KS, Franco JV. Shared decision-making for supporting women's decisions about breast cancer screening. Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2.

  PMID: 38726892 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Paulina Bravo, PhD

  Pontificia Universidad Catolica de Chile

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulina Bravo, PhD

CONTACT

(56-2) 2354 5838; pbbravo@uc.cl

Alejandra Martinez, MSc

CONTACT

+56940742491; alejandra.martinez@uc.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The intervention group will access a webpage, answers a set of questionnaires at baseline, and then the DA (developed according to the IPDAS recommendations). The Control group will access a webpage, answers a set of questionnaires at baseline, and then receive standardised information given by the healthcare system. Both groups will complete the questionnaires two weeks later.

Study Record Dates

• First Submitted: June 7, 2021
• First Posted: July 2, 2021
• Study Start: July 1, 2021
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: August 5, 2022

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)