The Effect of a Patient Decision Aids for Breast Cancer Screening

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer, Mammary Cancer, Breast Tumor, Mammary Tumor

Intervention / Treatment
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* Other: Decision aid (DA) for breast cancer screening
* Other: Standarised information for breast cancer screening


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>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<br>* 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?<br>|
| Placebo Comparator: Control group<br>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<br>* Information provided by the Chilean Ministry of Health in regards to access to breast cancer screening (Age, frequency and costs)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decisional conflict | Decisional conflict scale with 16 items that measure uncertainty in the decision making process. Minimum value= 16 Maximum value= 80 | Change from baseline decisional conflict at two weeks | 
| Depression, anxiety and stress | This will be measured with the DASS-21 Scale, a self-reported 21-item that captures depression, anxiety and stress during the last week. Minimum value= 21 Maximum value= 84 | Change from baseline drepression, anxiety and stress at two weeks | 
| Satisfaction with the decision | This is a two-item self-reported satisfaction questionnaire related to breast cancer screening. Minimum value= 0 Maximum value= 1 | Change from baseline satisfaction with the decision at two weeks | 
| Number of participants who undertake a mammography | This will be the number of women who decided to undertake the mammography. This outcome will be obtained from the clinical record of each participant six months after baseline questionnaires. Minimum value= 0 Maximum value= 1 | At 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Decision aid, Decision making process, Mammography, Breast Cancer Screening