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Completed

NCT Number: NCT03069742

Study of Web-based Decision Aids for Increasing Breast Cancer Chemoprevention in the Primary Care Setting

The purpose of this randomized controlled trial (RCT) is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer prevention options. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. The investigators hypothesize that improving accuracy of breast cancer risk perception and understanding of the risks and benefits of breast cancer risk lowering drugs, also known as chemoprevention, will increase the uptake of chemoprevention 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.

The investigators hypothesize 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. We anticipate that the BNAV tool will facilitate referrals to the breast clinic by primary care providers (PCPs) and that the RealRisks decision aid will prime high-risk women to seek these referrals. The primary endpoint is uptake of a selective estrogen receptor modulator (SERM) or Aromatase inhibitor (AI) for breast cancer chemoprevention at 6 months (after the next primary care appointment) in the active arm compared to usual care.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 5-year breast cancer risk ≥ to 1.67% or lifetime risk ≥ to 20% according to the Gail risk model; or a 5-year breast cancer risk ≥ 1.67% according to the Breast Cancer Surveillance Consortium (BCSC) 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. Chemoprevention uptake rate among high-risk women

    Time frame: 6 months (after the next primary care visit)

    The primary endpoint is to determine the uptake rate of a SERM or AI medication for breast cancer chemoprevention at 6 months (after the next primary care visit) in the active arm compared to usual care (control arm). Electronic health records will be used to track chemoprevention uptake after exposure to the intervention, the RealRisks decision aid, or the control, standard standard breast health education brochures.

Secondary outcomes

  1. Chemoprevention intention rate among high-risk women (Likert Scale Score)

    Time frame: 1 month

    Behavioral intention for chemoprevention will be assessed one month after baseline among those in the active arm compared to patients receiving usual care (control arm).

  2. High-risk referral rates to the breast clinic

    Time frame: 6 months (after the next primary care visit)

    To study appropriate referral rate to the breast clinic by primary care providers of high-risk patients in the active arm compared to patients receiving usual care (control arm).

  3. Completion of high-risk consultations at the breast clinic

    Time frame: 6 months (after the next primary care visit)

    To study appointment completion rate at the breast clinic by high-risk patients in the active arm compared to patients receiving usual care (control arm).

Other outcomes

  1. Change in the accuracy of risk perception (Likert Scale Score)

    Time frame: 6 months

    To measure the patient's accuracy of perceived breast cancer risk before and after exposure to the RealRisks decision aid compared to those patients in the control group receiving usual care. 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.

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

    Time frame: 6 months

    To assess patient's breast cancer knowledge before and after exposure to the RealRisks decision aid compared to those patients in the control arm by comparing the difference between a patient's responses to a 13-item scale assessing knowledge with response options of true, false, or unsure.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2020
Study completion
2022
First posted
Mar 3, 2017
Registry last updated
Mar 7, 2023

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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