NCT03470402

Brief Summary

The objective of this study is to expand genetic testing for hereditary breast and ovarian cancer syndrome to a broader population of high-risk women by prompting appropriate referrals from the primary care setting with the use of an electronic health record-embedded breast cancer risk navigation (BNAV) tool. To address patient-related barriers to genetic testing, the investigators developed a web-based decision aid, RealRisks, which is designed to improve genetic testing knowledge, accuracy of breast cancer risk perceptions, and self-efficacy to engage in a collaborative dialogue about genetic testing. The study design is a randomized controlled trial of patient educational materials and provider electronic health record (EHR) notice alone (control arm) or in combination with RealRisks and BNAV (intervention arm). The investigators hypothesize that combining the patient-centered RealRisks with the provider-centered BNAV will increase appropriate uptake of genetic counseling. The investigators also hypothesize that genetic counseling decisions will be more informed, and result in less decision conflict and improved shared decision making.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
276

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 20, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2020

Completed
Last Updated

April 19, 2021

Status Verified

April 1, 2021

Enrollment Period

2.7 years

First QC Date

March 13, 2018

Last Update Submit

April 15, 2021

Conditions

Breast CancerBRCA1 MutationBRCA2 MutationOvarian Cancer

Keywords

Breast Cancer PreventionGenetic TestingGenetic CounselingPersonalized PreventionPrecision PreventionPrecision MedicineRisk AssessmentDecision MakingDecision Aid

Outcome Measures

Primary Outcomes (1)

  • Uptake rate of genetic counseling by 6 months

    The primary endpoint is to determine the uptake of genetic counseling for HBOC syndrome by 6 months in the intervention arm (RealRisks Decision Aid and BNAV toolbox) compared to the control arm (Standard educational materials)

    Up to 6 months

Secondary Outcomes (3)

  • Change in patient decision conflict scale score

    Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months

  • Shared Decision Making (Likert Scale Score)

    Post Clinic Encounter (Approximately 6 Weeks)

  • Patient Informed Choice Score

    6 Months

Other Outcomes (13)

  • Change in Risk Perceptions (Likert Scale Score)

    Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months

  • Change in Breast Cancer Worry (Likert Scale Score)

    Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months

  • Change in Breast Cancer Knowledge scale score

    Baseline, Post Intervention/Control (1 Month), Post Clinic Encounter (Approximately 6 Weeks), 6 Months

  • +10 more other outcomes

Study Arms (2)

Intervention group

EXPERIMENTAL

Women who screen as eligible for BRCA genetic counseling will receive the education and decision support tool, RealRisks, along with standard educational material and a high-risk message. The high-risk status of the women will also be flagged in the online tool used by the hospital to visualize electronic health record data (iNYP). The enrolled health care providers of these women will be given access to BNAV, which summarizes their enrolled patients' breast cancer risk profiles and provides educational resources on genetic testing and prevention options. Before their clinical encounter with an enrolled patient, these providers will also be sent the personalized breast cancer risk summary that is created by data the patient entered into RealRisks.

Other: RealRisksOther: BNAVOther: iNYPOther: Standard Educational MaterialOther: High-Risk Message

Control group

ACTIVE COMPARATOR

Women who screen as eligible for BRCA genetic counseling will receive standard educational material and a high-risk message. The high-risk status of the women will also be flagged in the online tool used by the hospital to visualize electronic health record data (iNYP).

Other: iNYPOther: Standard Educational MaterialOther: High-Risk Message

Interventions

RealRisksOTHER

RealRisks is a web-based patient decision aid with modules on risk assessment, family history and breast cancer, genetic testing, and prevention options. Participants enter family history data into RealRisks, and RealRisks calculates 5-year breast cancer risk, lifetime breast cancer risk, and the probability of carrying a BRCA mutation. This information is then interactively presented to the participant. RealRisks facilitates the participant in identifying their intention to undergo BRCA genetic testing and the factors that are important to the participant in making this decision. RealRisks produces a summary of all of this information that the participant can print and take with her to a health care appointment.

Also known as: RealRisks Decision Aid
Intervention group
BNAVOTHER

BNAV is a web-based decision support tool for healthcare providers with educational modules on genetic testing, chemoprevention, patient-centered care, and screening. BNAV also provides providers with a table outlining their enrolled patients' breast cancer risk, eligibility for genetic testing, and stated preferences.

Also known as: Breast Cancer Risk Navigation Tool, BNAV Toolbox
Intervention group
iNYPOTHER

Enrolled patients will have their eligibility for BRCA genetic testing flagged in iNYP, the hospital's portal for visualizing EHR data (standard practice).

Control groupIntervention group
Standard Educational MaterialOTHER

Enrolled patient participants will be sent standard educational brochures on genes and breast cancer and the CUMC breast cancer prevention clinic

Also known as: Standard Educational Brochures
Control groupIntervention group
High-Risk MessageOTHER

Enrolled patient participants will receive a letter that informs them that they meet eligibility criteria for BRCA genetic testing, outlines prevention options, and recommends discussing genetic counseling referral with their health care provider (standard practice).

Also known as: High Risk Letter
Control groupIntervention group

Eligibility Criteria

Age21 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women, age 21-75 years
  • Meets criteria for genetic testing based on family history
  • Sees a primary care provider in the Columbia University (CUMC) /New York Presbyterian (NYP) Ambulatory Care Network
  • Understands as is willing to provide informed consent in English or in Spanish

You may not qualify if:

  • Prior genetic counseling or testing for hereditary breast and ovarian cancer (HBOC)
  • A personal history of breast or ovarian cancer
  • Primary care providers, such as attending physicians, residents, nurse practitioners, physician assistants, and midwives, who see patients at CUMC/NYP Ambulatory Care Network clinics
  • Able to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

  • Kukafka R, Pan S, Silverman T, Zhang T, Chung WK, Terry MB, Fleck E, Younge RG, Trivedi MS, McGuinness JE, He T, Dimond J, Crew KD. Patient and Clinician Decision Support to Increase Genetic Counseling for Hereditary Breast and Ovarian Cancer Syndrome in Primary Care: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2222092. doi: 10.1001/jamanetworkopen.2022.22092.

    PMID: 35849397DERIVED

  • Silverman TB, Vanegas A, Marte A, Mata J, Sin M, Ramirez JCR, Tsai WY, Crew KD, Kukafka R. Study protocol: a cluster randomized controlled trial of web-based decision support tools for increasing BRCA1/2 genetic counseling referral in primary care. BMC Health Serv Res. 2018 Aug 13;18(1):633. doi: 10.1186/s12913-018-3442-x.

    PMID: 30103738DERIVED

MeSH Terms

Conditions

Breast NeoplasmsOvarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • 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
Model Details: A cluster randomization in which both a provider and his/her enrolled patients will be enrolled in either the intervention or control arm.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 20, 2018

Study Start

December 13, 2017

Primary Completion

August 17, 2020

Study Completion

August 17, 2020

Last Updated

April 19, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)