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

NCT03069742 | Completed

• 2 other identifiers: AAAP4151 IIR01CA177995
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm

Keywords

Breast Cancer Prevention; Risk Assessment; Chemoprevention; Decision Making

Outcome Measures

Primary Outcomes (1)

• Chemoprevention uptake rate among high-risk women

  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.

  6 months (after the next primary care visit)

Secondary Outcomes (3)

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

  1 month

• High-risk referral rates to the breast clinic

  6 months (after the next primary care visit)

• Completion of high-risk consultations at the breast clinic

  6 months (after the next primary care visit)

Other Outcomes (2)

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

  6 months

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

  6 months

Study Arms (2)

Decision Aid

EXPERIMENTAL

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; Other: BNAV

Control Group

NO INTERVENTION

Women at high risk for developing breast cancer will receive standard breast health education brochures.

Interventions

RealRisks OTHER

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

Also known as: RealRisks patient-centered decision aid (DA)

Decision Aid

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.

Also known as: Breast Cancer Risk Navigation (BNAV) tool, BNAV provider clinical decision support tool

Decision Aid

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Columbia University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (3)

• 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.

  PMID: 26175193 BACKGROUND

• Yi 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.

  PMID: 26958276 BACKGROUND

• Crew KD, Silverman TB, Vanegas A, Trivedi MS, Dimond J, Mata J, Sin M, Jones T, Terry MB, Tsai WY, Kukafka R. Study protocol: Randomized controlled trial of web-based decision support tools for high-risk women and healthcare providers to increase breast cancer chemoprevention. Contemp Clin Trials Commun. 2019 Aug 22;16:100433. doi: 10.1016/j.conctc.2019.100433. eCollection 2019 Dec.

  PMID: 31497674 DERIVED

Related Links

• Pre-screening questionnaire

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Katherine D Crew, MD, MS

  Columbia University

  PRINCIPAL INVESTIGATOR

• Rita Kukafka, DrPH, MA

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: November 1, 2016
• Primary Completion: October 1, 2020
• Study Completion: August 1, 2022
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

US (1)