The Effect of a Patient Decision Aids for Breast Cancer Screening

NCT04948983 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3269

Last updated 2022-08-05

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Comisión Nacional de Investigación Científica y Tecnológica

    collaborator OTHER_GOV
  • Pontificia Universidad Catolica de Chile

    lead OTHER

Principal Investigators

  • Paulina Bravo, PhD · Pontificia Universidad Catolica de Chile

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • Chile

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04948983 on ClinicalTrials.gov