Breast Cancer Clinical Trial
Official title:
Patient Decision Aids for Women Facing the Decision of Breast Cancer Screening in the Public Health Sector
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.
Status | Recruiting |
Enrollment | 3269 |
Est. completion date | October 31, 2022 |
Est. primary completion date | October 31, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 69 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Chile | Alejandra Martínez | Santiago |
Lead Sponsor | Collaborator |
---|---|
Pontificia Universidad Catolica de Chile | Comisión Nacional de Investigación Científica y Tecnológica |
Chile,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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