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

NCT ID: NCT02954900

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-15
• Study Completion Date: 2018-10-31

Brief Summary

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.

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.

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.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Decision aid

50 women at high-risk for developing breast cancer will use a decision support tool, RealRisks, when discussing breast cancer risk with their providers who will have access to the BNAV provider clinical decision support tool.

Group Type: OTHER

RealRisks

Intervention Type: OTHER

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

BNAV

Intervention Type: 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.

Interventions

RealRisks

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

Intervention Type: 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.

Intervention Type: OTHER

Other Intervention Names

RealRisks patient-centered decision aid (DA); Breast Cancer Risk Navigation (BNAV) tool; BNAV provider clinical decision support tool

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Katherine D. Crew

Associate Professor of Medicine and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Katherine D Crew, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26175193 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26958276 (View on PubMed)

Kukafka R, Fang J, Vanegas A, Silverman T, Crew KD. Pilot study of decision support tools on breast cancer chemoprevention for high-risk women and healthcare providers in the primary care setting. BMC Med Inform Decis Mak. 2018 Dec 17;18(1):134. doi: 10.1186/s12911-018-0716-5.

Reference Type: DERIVED

PMID: 30558581 (View on PubMed)

Other Identifiers

R01CA177995

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAP4151 I

Identifier Type: -

Identifier Source: org_study_id