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Completed

NCT Number: NCT02954900

Know Your Risk: Assessment at Screening for Breast Cancer - Pilot Study

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.

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Key information

Age range

35 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) for chemoprevention
  • Prior history of breast cancer

Treatment and study plan

RealRisks

Other

RealRisks is a web-based patient decision aid with modules that present information about risk assessment and chemoprevention.

Other names: RealRisks patient-centered decision aid (DA)

BNAV

Other

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.

Other names: Breast Cancer Risk Navigation (BNAV) tool, BNAV provider clinical decision support tool

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in a patient's breast cancer knowledge (Survey Score)

    Time frame: Baseline, 2 weeks

    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.

  2. Chemoprevention uptake rate among high-risk women

    Time frame: 6 months

    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.

  3. Referral rates to the breast clinic

    Time frame: 12 months

    To study appropriate referral rate by primary care providers of high-risk patients to the breast clinic.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Study of Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Pilot

Acronym: KYRAS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 4, 2016
Registry last updated
Jan 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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