NCT03624088

Brief Summary

This study evaluates a web-based decision aid, named RealRisks, in promoting genetic testing intention among Orthodox Jewish women. 50 Orthodox Jewish women will take a baseline survey, self-administer the decision aid, and then complete two more surveys: one within one month of completing the decision aid and one at 6 months after completing the decision aid.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable breast-cancer

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

March 13, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

11 months

First QC Date

August 7, 2018

Last Update Submit

January 30, 2019

Conditions

Breast Cancer

Keywords

Breast Cancer PreventionGenetic TestingOrthodox JewishCommunity-Based Participatory ResearchBRCADecision Support

Outcome Measures

Primary Outcomes (1)

  • Change in proportion of participants who intend to undergo or have completed genetic testing compared to baseline

    Question assessing subject's intention of undergoing genetic testing or completion of genetic testing

    1 month

Secondary Outcomes (1)

  • Change in proportion of participants who make an informed choice about getting BRCA genetic testing.

    1 month, 6 months

Other Outcomes (10)

  • Change in proportion of participants who have accurate breast cancer risk perception

    1 month, 6 months

  • Change in proportion of participants who describe experiencing significant breast cancer worry

    1 month, 6 months

  • Change in BRCA testing knowledge

    1 month, 6 months

  • +7 more other outcomes

Study Arms (1)

Single-Arm Intervention

EXPERIMENTAL

Participants will complete a baseline questionnaire. They will then self-administer the web-based decision aid, RealRisks. Upon completion, they will complete two more surveys: one within 1 month of completing RealRisks and one six months after completing RealRisks.

Behavioral: RealRisks

Interventions

RealRisksBEHAVIORAL

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
Single-Arm Intervention

Eligibility Criteria

Age25 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>= 25 years of age
  • Completed a previous cross-sectional survey and agreed to future contact
  • Eligible for BRCA testing based on Six Point Scale

You may not qualify if:

  • Personal history of breast or ovarian cancer
  • Prior genetic counseling or genetic testing for BRCA mutations
  • Participated in previous RealRisks workshop

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 (1)

  • Trivedi MS, Manley H, Yi H, Silverman T, Chung WK, Appelbaum PS, Starck R, Schecter I, Kukafka R, Crew KD. Pilot study of a decision aid on BRCA1/2 genetic testing among Orthodox Jewish women. Fam Cancer. 2024 Nov;23(4):491-498. doi: 10.1007/s10689-024-00371-6. Epub 2024 Apr 12.

    PMID: 38609522DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Katherine D Crew, MD, MS

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Epidemiology at the Columbia University Medical Center

Study Record Dates

First Submitted

August 7, 2018

First Posted

August 9, 2018

Study Start

March 13, 2018

Primary Completion

January 29, 2019

Study Completion

January 29, 2019

Last Updated

January 31, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)