The Effect of a Patient Decision Aids for Breast Cancer Screening

NCT ID: NCT04948983

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3269 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2022-10-31

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.

Detailed Description

There is an alarming rise of breast cancer in developing countries, where early detection is rare and the late findings build up an important mortality rate. In Chile, the mortality rate is 15,5 per 100.000 women, where breast cancer is the first death caused by tumors. Governmental efforts had focused on increase an opportune detection and had offered universal and guaranteed access to breast cancer screening to women in at-risk age (50 to 59 years old). Still, about 30% of the women of at-risk age choose to not do the mammogram. Anxiety and lack of awareness are the principal reasons associated with the decision of rejecting or postponing the exam. Women would have trouble in making an informed decision about the breast cancer exam, resulting in possible negatives consequences for their wellbeing. Considering that the health-related decision-making process depends importantly on the personal balance of risk and benefits related to the decision, it is imperative to explore strategies that support women in the decision-making progress for breast cancer screening.

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; 4) A two-arm randomized control trial will be conducted with a total of 3,269 women aged 50 to 69 years old in ten primary care centres in Chile.

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 receives standardised information given by the healthcare system. Both groups will 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 will be measure. Multiple lineal regression analysis will be conducted.

Conditions

Breast Cancer; Mammary Cancer; Breast Tumor; Mammary Tumor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Intervention group

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?

Group Type: ACTIVE_COMPARATOR

Decision aid (DA) for breast cancer screening

Intervention Type: 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?

Control group

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.

Group Type: PLACEBO_COMPARATOR

Standarised information for breast cancer screening

Intervention Type: OTHER

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

Interventions

Decision aid (DA) for breast cancer screening

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 Type: OTHER

Standarised information for breast cancer screening

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Comisión Nacional de Investigación Científica y Tecnológica

OTHER_GOV

Sponsor Role: collaborator

Pontificia Universidad Catolica de Chile

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paulina Bravo, PhD

Role: PRINCIPAL_INVESTIGATOR

Pontificia Universidad Catolica de Chile

Locations

Alejandra Martínez

Santiago, , Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Paulina Bravo, PhD

Role: CONTACT

pbbravo@uc.cl

(56-2) 2354 5838

Alejandra Martinez, MSc

Role: CONTACT

alejandra.martinez@uc.cl

+56940742491

Facility Contacts

Alejandra Martínez

Role: primary

References

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.

Reference Type: RESULT

PMID: 33592532 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 38726892 (View on PubMed)

Other Identifiers

SA18i0002

Identifier Type: -

Identifier Source: org_study_id