Clinical trial NCT04948983: The Effect of a Patient Decision Aids for Breast Cancer Screening
Official title: Patient Decision Aids for Women Facing the Decision of Breast Cancer Screening in the Public Health Sector
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Mammary Cancer
Breast Tumor
Mammary Tumor
Keywords: Breast Cancer
Decision aid
Decision making process
Mammography
Breast Cancer Screening
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
Collaborators: name: Comisión Nacional de Investigación Científica y Tecnológica
First posted: 2021-07-02
Enrollment: 3269
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Informed choice for breast cancer screening
timeFrame: Change from baseline informed choice at two weeks
Secondary outcomes:
measure: Decisional conflict
timeFrame: Change from baseline decisional conflict at two weeks
measure: Depression, anxiety and stress
timeFrame: Change from baseline drepression, anxiety and stress at two weeks
measure: Satisfaction with the decision
timeFrame: Change from baseline satisfaction with the decision at two weeks
measure: Number of participants who undertake a mammography
timeFrame: At 6 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Alejandra Martínez
Study officials:
affiliation: Pontificia Universidad Catolica de Chile
name: Paulina Bravo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.