Breast CancerNCT04948983
The Effect of a Patient Decision Aids for Breast Cancer Screening
A study testing Decision aid (DA) for breast cancer screening and Standarised information for breast cancer screening in people with Breast Cancer and Mammary Cancer, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 69 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Mammary Cancer, Breast Tumor
- What is being tested?
- Decision aid (DA) for breast cancer screening and Standarised information for breast cancer screening
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,269 participants
- Where
- 1 siteChile
- Study dates
- 1 Jul 2021to 31 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 69 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women from 50 to 69 years old
- Attend the primary care centres
- Fluent in Spanish
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Alejandra Martínez
Santiago, sANTIAGO
Alejandra Martínez
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Mammary Cancer, Breast Tumor, Mammary Tumor
- Being tested
- Decision aid (DA) for breast cancer screening, Standarised information for breast cancer screening
- Keywords
- Breast Cancer, Decision aid, Decision making process, Mammography, Breast Cancer Screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision aid (DA) for breast cancer screeningOther
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?
Standarised information for breast cancer screeningOther
Information provided by the Chilean Ministry of Health in regards to access to breast cancer screening (Age, frequency and costs)
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | 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? Receives: Other: Decision aid (DA) for breast cancer screening |
| Control group | Placebo comparator | 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. Receives: Other: Standarised information for breast cancer screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from baseline informed choice at two weeks
Secondary outcomes (4)
Decisional conflict
Decisional conflict scale with 16 items that measure uncertainty in the decision making process.
Minimum value= 16 Maximum value= 80
Measured: 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
Measured: 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
Measured: 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
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start1 Jul 2021
- Primary completion31 Oct 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Pontificia Universidad Catolica de ChileThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 3,269 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pontificia Universidad Catolica de Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Responsible party
- Sponsor
- Investigators
- Paulina Bravo, PhD, Principal investigator, Pontificia Universidad Catolica de Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948983
- Sponsor's protocol ID
- SA18i0002
- Status last verified
- Oct 2021
- First submitted
- 7 Jun 2021
- Last updated
- 5 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33592532Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, Alarcon-Ruiz CA, Kopitowski KS, Franco JV. Shared decision-making for supporting women's decisions about breast cancer screening. Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2.
PubMed 38726892
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Decision Aids for Women Facing the Decision of Breast Cancer Screening in the Public Health Sector
- ClinicalTrials.gov ID
- NCT04948983
- Acronym / sponsor ID
- SA18i0002
- Conditions
- Breast Cancer, Mammary Cancer, Breast Tumor, Mammary Tumor
- Keywords
- Breast Cancer, Decision aid, Decision making process, Mammography, Breast Cancer Screening
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,269 participants (estimated)
- Lead sponsor
- Pontificia Universidad Catolica de ChileUniversity, hospital or other
- Collaborators
- Comisión Nacional de Investigación Científica y Tecnológica
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 31 Oct 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Decision aid (DA) for breast cancer screeningThe 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? |
| Control group | Placebo comparator | Other: Standarised information for breast cancer screeningThe 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. |
Who may qualify
- Ages
- 50 to 69 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women from 50 to 69 years old
- Attend the primary care centres
- Fluent in Spanish
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision aid (DA) for breast cancer screeningThe 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 | Intervention group |
| Standarised information for breast cancer screeningInformation provided by the Chilean Ministry of Health in regards to access to breast cancer screening (Age, frequency and costs) | Other | Control group |
Primary outcome
Informed choice for breast cancer screening
Time frame: Change from baseline informed choice at two weeks
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
4 secondary outcomes
Decisional conflict
Time frame: Change from baseline decisional conflict at two weeks
Depression, anxiety and stress
Time frame: Change from baseline drepression, anxiety and stress at two weeks
Satisfaction with the decision
Time frame: Change from baseline satisfaction with the decision at two weeks
Number of participants who undertake a mammography
Time frame: At 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Results publication: PubMed 33592532Bravo 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.
- Derived from this study: PubMed 38726892Riganti P, Ruiz Yanzi MV, Escobar Liquitay CM, Sgarbossa NJ, Alarcon-Ruiz CA, Kopitowski KS, Franco JV. Shared decision-making for supporting women's decisions about breast cancer screening. Cochrane Database Syst Rev. 2024 May 10;5(5):CD013822. doi: 10.1002/14651858.CD013822.pub2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulina Bravo, PhD principal investigator
Pontificia Universidad Catolica de Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision aid (DA) for breast cancer screening and Standarised information for breast cancer screening in people with Breast Cancer and Mammary Cancer, run by Pontificia Universidad Catolica de Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paulina Bravo, PhD ((56-2) 2354 5838, pbbravo@uc.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Informed choice for breast cancer screening (time frame: Change from baseline informed choice at two weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04948983, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.