NCT04948983

The Effect of a Patient Decision Aids for Breast Cancer Screening

Patient Decision Aids for Women Facing the Decision of Breast Cancer Screening in the Public Health Sector

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,269 (estimated)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: Female
• Age: 50 Years – 69 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
OTHER	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?
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)

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2021-07-02
• Last updated: 2022-08-05

Locations

1 site across 1 country: Chile