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

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ClinicalTrials.gov Identifier: NCT03069742
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : May 11, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Katherine D. Crew, Columbia University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasm Other: RealRisks Other: BNAV Not Applicable

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.

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Randomized Controlled Trial
Study Start Date : November 2016
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Decision Aid
Women at high risk for developing breast cancer will use a decision support tool, RealRisks, that facilitates discussion of breast cancer risk with their providers who will have access to the BNAV provider clinical decision support tool.
Other: RealRisks
RealRisks is a web-based patient decision aid with modules that present information about risk assessment and chemoprevention.
Other Name: RealRisks patient-centered decision aid (DA)

Other: BNAV
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

No Intervention: Control Group
Women at high risk for developing breast cancer will receive standard breast health education brochures.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069742


Contacts
Contact: Alejandro Vanegas, MS 212-305-8452 kyras@cumc.columbia.edu
Contact: Jennifer M Vargas, BS 212-851-4921 kyras@cumc.columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Alejandro Vanegas, M.S.    212-851-4928    kyras@cumc.columbia.edu   
Contact: Jennifer Vargas, B.S.    212-851-4921    kyras@cumc.columbia.edu   
Principal Investigator: Katherine D Crew, MD, MS         
Principal Investigator: Rita Kukafka, DrPH, MA         
Sponsors and Collaborators
Columbia University
National Cancer Institute (NCI)
Investigators
Principal Investigator: Katherine D Crew, MD, MS Columbia University
Principal Investigator: Rita Kukafka, DrPH, MA Columbia University

Additional Information:
Publications:
Responsible Party: Katherine D. Crew, Associate Professor of Medicine and Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT03069742     History of Changes
Other Study ID Numbers: AAAP4151 II
R01CA177995 ( U.S. NIH Grant/Contract )
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Katherine D. Crew, Columbia University:
Breast Cancer Prevention
Risk Assessment
Chemoprevention
Decision Making

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases