Breast NeoplasmsKYRASNCT02954900
Know Your Risk: Assessment at Screening for Breast Cancer - Pilot Study
A study testing RealRisks and BNAV in people with Breast Neoplasms, run by Columbia University at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer chemoprevention. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. Read more about this study
- Who is it for?
- Ages 35 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- RealRisks and BNAV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2016to Oct 2018
- 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 35 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 5-year breast risk of 1.67% or lifetime risk of 20% according to the Gail model
- The participant understands and is willing to provide informed consent in English or Spanish
- Has a primary care provider at Columbia University Medical Center (CUMC) / New York-Presbyterian Hospital
Who cannot join
- Prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) for chemoprevention
- Prior history of breast cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Study of Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Pilot
The purpose of this pilot study is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer chemoprevention. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. The investigator hypothesizes that improving accuracy of breast cancer risk perception and understanding of the risks/benefits of chemoprevention will enhance informed decision-making and uptake of breast cancer prevention strategies in the primary care setting.
Read the detailed description
Breast cancer is the most common malignancy among women in the U.S. and the primary prevention of this disease is a major public health issue. The U.S. Preventive Services Task Force and other professional organizations recommend that clinicians discuss chemoprevention with high-risk women. Breast cancer chemoprevention with anti-estrogens, such as tamoxifen, raloxifene, exemestane, and anastrozole, is under-utilized, despite several randomized controlled trials demonstrating a 40-65% decrease in breast cancer incidence among high-risk women. Compounding this underutilization is the fact that a large proportion of women may be unaware of their high-risk status due to the investigators inability to adequately screen them in the primary care setting. Further research is needed to determine how knowledge about breast cancer, actual/perceived risk, and risks/benefits of chemoprevention are best communicated to women in order to promote breast cancer prevention strategies.
This study assesses risk communication and shared decision-making in patient-clinician dyads by administering validated measures at baseline, after interacting with the tools prior to the clinic visit, and after the clinical visit (quantitative analysis); and by using observer-based methods of audio-tape recordings of their clinical encounters (qualitative analysis).
The investigator hypothesizes that combining a patient-centered decision aid with a physician-centered decision support tool integrated into clinic workflow will improve accuracy of breast cancer risk perception, facilitate referrals for specialized risk counseling, and increase chemoprevention uptake.
- Conditions
- Breast Neoplasms
- Being tested
- RealRisks, BNAV
- Keywords
- Breast Cancer Prevention, Risk Assessment, Chemoprevention, Decision Making
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RealRisksOther
Also called RealRisks patient-centered decision aid (DA)
RealRisks is a web-based patient decision aid with modules that present information about risk assessment and chemoprevention.
BNAVOther
Also called Breast Cancer Risk Navigation (BNAV) tool, BNAV provider clinical decision support tool
Breast Cancer Risk Navigation (BNAV) tool is a web-based decision support tool with modules that present pertinent information for primary care providers regarding breast cancer risk assessment and preventative measures for their patients.
| Study group | Role | What they receive |
|---|---|---|
| Decision aid | Other | 50 women at high-risk for developing breast cancer will use a decision support tool, RealRisks, when discussing breast cancer risk with their providers who will have access to the BNAV provider clinical decision support tool. Receives: Other: RealRisks; Other: BNAV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the accuracy of risk perception (Likert Scale Score)
To measure the patient's accuracy of perceived breast cancer risk before and after exposure to the RealRisks decision aid. Perception will be assessed by comparing the difference between a patient's perceived risk and their actual risk based on the Gail breast cancer model. Patients are asked to make a comparative risk assessment about themselves on a 3-point Likert scale.
Measured: Baseline, 2 weeks
Secondary outcomes (3)
Change in a patient's breast cancer knowledge (Survey Score)
To assess patient's breast cancer knowledge before and after exposure to the RealRisks decision aid by comparing the difference between a patient's responses to a 13-item scale assessing knowledge with response options of true, false, or unsure.
Measured: Baseline, 2 weeks
Chemoprevention uptake rate among high-risk women
To determine the uptake rate in the breast clinic after offering specialized risk counseling to a broader population of racially/ethnically diverse women screened in the primary care setting. Electronic health records will be used to track chemoprevention uptake after exposure to the RealRisks decision aid.
Measured: 6 months
Referral rates to the breast clinic
To study appropriate referral rate by primary care providers of high-risk patients to the breast clinic.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start15 Mar 2016
- Primary completionOct 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Katherine D. Crew, Columbia University
- Investigators
- Katherine D Crew, M.D., M.S., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954900
- Sponsor's protocol ID
- AAAP4151 I
- Other IDs
- R01CA177995
- Acronym
- KYRAS
- Status last verified
- Jan 2021
- First submitted
- 12 Jul 2016
- Last updated
- 8 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kukafka R, Yi H, Xiao T, Thomas P, Aguirre A, Smalletz C, David R, Crew K. Why Breast Cancer Risk by the Numbers Is Not Enough: Evaluation of a Decision Aid in Multi-Ethnic, Low-Numerate Women. J Med Internet Res. 2015 Jul 14;17(7):e165. doi: 10.2196/jmir.4028.
PubMed 26175193Yi H, Xiao T, Thomas PS, Aguirre AN, Smalletz C, Dimond J, Finkelstein J, Infante K, Trivedi M, David R, Vargas J, Crew KD, Kukafka R. Barriers and Facilitators to Patient-Provider Communication When Discussing Breast Cancer Risk to Aid in the Development of Decision Support Tools. AMIA Annu Symp Proc. 2015 Nov 5;2015:1352-60. eCollection 2015.
PubMed 26958276Kukafka R, Fang J, Vanegas A, Silverman T, Crew KD. Pilot study of decision support tools on breast cancer chemoprevention for high-risk women and healthcare providers in the primary care setting. BMC Med Inform Decis Mak. 2018 Dec 17;18(1):134. doi: 10.1186/s12911-018-0716-5.
PubMed 30558581
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Pilot
- ClinicalTrials.gov ID
- NCT02954900
- Acronym / sponsor ID
- KYRAS / AAAP4151 I
- Conditions
- Breast Neoplasms
- Keywords
- Breast Cancer Prevention, Risk Assessment, Chemoprevention, Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Mar 2016
- Primary completion
- Oct 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 4 Nov 2016 (estimated)
- 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.
The purpose of this pilot study is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer chemoprevention. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. The investigator hypothesizes that improving accuracy of breast cancer risk perception and understanding of the risks/benefits of chemoprevention will enhance informed decision-making and uptake of breast cancer prevention strategies in the primary care setting.
Detailed description
Breast cancer is the most common malignancy among women in the U.S. and the primary prevention of this disease is a major public health issue. The U.S. Preventive Services Task Force and other professional organizations recommend that clinicians discuss chemoprevention with high-risk women. Breast cancer chemoprevention with anti-estrogens, such as tamoxifen, raloxifene, exemestane, and anastrozole, is under-utilized, despite several randomized controlled trials demonstrating a 40-65% decrease in breast cancer incidence among high-risk women. Compounding this underutilization is the fact that a large proportion of women may be unaware of their high-risk status due to the investigators inability to adequately screen them in the primary care setting. Further research is needed to determine how knowledge about breast cancer, actual/perceived risk, and risks/benefits of chemoprevention are best communicated to women in order to promote breast cancer prevention strategies.
This study assesses risk communication and shared decision-making in patient-clinician dyads by administering validated measures at baseline, after interacting with the tools prior to the clinic visit, and after the clinical visit (quantitative analysis); and by using observer-based methods of audio-tape recordings of their clinical encounters (qualitative analysis).
The investigator hypothesizes that combining a patient-centered decision aid with a physician-centered decision support tool integrated into clinic workflow will improve accuracy of breast cancer risk perception, facilitate referrals for specialized risk counseling, and increase chemoprevention uptake.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision aid | Other | Other: RealRisks, Other: BNAV50 women at high-risk for developing breast cancer will use a decision support tool, RealRisks, when discussing breast cancer risk with their providers who will have access to the BNAV provider clinical decision support tool. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 5-year breast risk of 1.67% or lifetime risk of 20% according to the Gail model
- The participant understands and is willing to provide informed consent in English or Spanish
- Has a primary care provider at Columbia University Medical Center (CUMC) / New York-Presbyterian Hospital
Key exclusion criteria (2 listed)
- Prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) for chemoprevention
- Prior history of breast cancer
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 |
|---|---|---|
| RealRisksAlso: RealRisks patient-centered decision aid (DA)RealRisks is a web-based patient decision aid with modules that present information about risk assessment and chemoprevention. | Other | Decision aid |
| BNAVAlso: Breast Cancer Risk Navigation (BNAV) tool, BNAV provider clinical decision support toolBreast Cancer Risk Navigation (BNAV) tool is a web-based decision support tool with modules that present pertinent information for primary care providers regarding breast cancer risk assessment and preventative measures for their patients. | Other | Decision aid |
Primary outcome
Change in the accuracy of risk perception (Likert Scale Score)
Time frame: Baseline, 2 weeks
To measure the patient's accuracy of perceived breast cancer risk before and after exposure to the RealRisks decision aid. Perception will be assessed by comparing the difference between a patient's perceived risk and their actual risk based on the Gail breast cancer model. Patients are asked to make a comparative risk assessment about themselves on a 3-point Likert scale.
3 secondary outcomes
Change in a patient's breast cancer knowledge (Survey Score)
Time frame: Baseline, 2 weeks
Chemoprevention uptake rate among high-risk women
Time frame: 6 months
Referral rates to the breast clinic
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2021.
- Background: PubMed 26175193Kukafka R, Yi H, Xiao T, Thomas P, Aguirre A, Smalletz C, David R, Crew K. Why Breast Cancer Risk by the Numbers Is Not Enough: Evaluation of a Decision Aid in Multi-Ethnic, Low-Numerate Women. J Med Internet Res. 2015 Jul 14;17(7):e165. doi: 10.2196/jmir.4028.
- Background: PubMed 26958276Yi H, Xiao T, Thomas PS, Aguirre AN, Smalletz C, Dimond J, Finkelstein J, Infante K, Trivedi M, David R, Vargas J, Crew KD, Kukafka R. Barriers and Facilitators to Patient-Provider Communication When Discussing Breast Cancer Risk to Aid in the Development of Decision Support Tools. AMIA Annu Symp Proc. 2015 Nov 5;2015:1352-60. eCollection 2015.
- Derived from this study: PubMed 30558581Kukafka R, Fang J, Vanegas A, Silverman T, Crew KD. Pilot study of decision support tools on breast cancer chemoprevention for high-risk women and healthcare providers in the primary care setting. BMC Med Inform Decis Mak. 2018 Dec 17;18(1):134. doi: 10.1186/s12911-018-0716-5.
- Individual participant dataSharing planned: Undecided
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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.
Katherine D Crew, M.D., M.S. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RealRisks and BNAV in people with Breast Neoplasms, run by Columbia University at 1 site in United States.
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 2 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: finished, as of the sponsor's last update on 8 Jan 2021. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the accuracy of risk perception (Likert Scale Score) (time frame: Baseline, 2 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 NCT02954900, which also lists 3 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 8 Jan 2021.