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
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
- Breast Cancer
- Mammary Cancer
- Breast Tumor
- Mammary Tumor
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
More Related Trials
-
Communicating Objective Risk for Personalized Decision Making About Mammography
NCT01686360 ·Status: COMPLETED ·Phase: NA
-
Feasibility of Breast Cancer Risk Evaluation in Women From the General Population
NCT02997384 ·Status: UNKNOWN
-
Psychosocial Study on Breast Cancer Risk Assessment
NCT00234715 ·Status: COMPLETED
-
Breast Cancer and Quality of Life
NCT01661816 ·Status: COMPLETED
-
Trial of a Mammography Decision Aid for Women Aged 75 and Older
NCT02198690 ·Status: COMPLETED ·Phase: NA
-
Sexual Health in Breast Cancer Patients
NCT05138510 ·Status: COMPLETED
-
Avoiding Low-value Treatments in Older Women With Early-stage Breast Cancer: Piloting a Patient Decision Aid
NCT05140252 ·Status: COMPLETED ·Phase: NA
-
Assessment of Feasibility and Acceptability of Personalized Breast Cancer Screening
NCT03791008 ·Status: COMPLETED ·Phase: NA
-
Study for the Knowledge of Risk Factors Associated With Breast Cancer in Women
NCT03918668 ·Status: COMPLETED
-
Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study
NCT05838417 ·Status: COMPLETED ·Phase: NA
-
Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool
NCT04741503 ·Status: COMPLETED ·Phase: NA
-
Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information in Women
NCT06441474 ·Status: ACTIVE_NOT_RECRUITING ·Phase: NA
-
Analysis of Patient Understanding of Radiation Therapy Among Patients With Breast Cancer
NCT05114525 ·Status: COMPLETED ·Phase: NA
-
Monitoring of Neoadjuvant Therapy in Locally-Advanced Breast Cancer
NCT01837563 ·Status: TERMINATED
-
Optimizing the Care Pathways of Patients Treated for Operable Breast.
NCT02813317 ·Status: COMPLETED
-
Study of Sentinel Lymph Node Assessment Following Previous Surgical Biopsy for Early Breast Cancer
NCT00293865 ·Status: COMPLETED ·Phase: NA
-
Australian Screening Mammography Decision Aid Trial: A Decision Aid for Women Aged 40 Thinking About Starting Mammography Screening
NCT00139048 ·Status: COMPLETED ·Phase: NA
-
Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients
NCT05981326 ·Status: RECRUITING ·Phase: NA
-
Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information: Administrative Supplement Study
NCT06975085 ·Status: COMPLETED ·Phase: PHASE2
-
Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy
NCT00535184 ·Status: COMPLETED
-
Effectiveness of a Decision Support System in Improving the Diagnosis and Screening Rate of Breast Cancer
NCT01336257 ·Status: UNKNOWN ·Phase: NA
-
Elevate! : An Elderly Breast Cancer Cohort Study
NCT03818087 ·Status: ACTIVE_NOT_RECRUITING
-
A Decision Aid for Women With Early Stage Breast Cancer
NCT00201929 ·Status: COMPLETED ·Phase: PHASE3
-
Multicenter Study to Evaluate a Systematized Communication Model for Breast Cancer Patients
NCT05837533 ·Status: COMPLETED ·Phase: NA
-
The Effect of Health Education Conducted Using Two Different Methods on Women's Knowledge of Breast Cancer, Health Beliefs, Mammography Self-Efficacy, and Participation in Screening Programs
NCT07083310 ·Status: NOT_YET_RECRUITING ·Phase: NA