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 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasm||Other: RealRisks Other: BNAV||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 :||October 2019|
|Estimated Study Completion Date :||October 2020|
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.
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)
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.
No Intervention: Control Group
Women at high risk for developing breast cancer will receive standard breast health education brochures.
- 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.
- 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).
- 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).
- 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).
- 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.
- 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.
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
|Contact: Alejandro Vanegas, MSfirstname.lastname@example.org|
|Contact: Jennifer M Vargas, BSemail@example.com|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Contact: Alejandro Vanegas, M.S. 212-851-4928 firstname.lastname@example.org|
|Contact: Jennifer Vargas, B.S. 212-851-4921 email@example.com|
|Principal Investigator: Katherine D Crew, MD, MS|
|Principal Investigator: Rita Kukafka, DrPH, MA|
|Principal Investigator:||Katherine D Crew, MD, MS||Columbia University|
|Principal Investigator:||Rita Kukafka, DrPH, MA||Columbia University|