Usefulness of Video-Based Intervention in Helping Participants Encourage Their Families to Get Tested for BRCA Gene Mutations

NCT ID: NCT05264532

Last Updated: 2025-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-05

Study Completion Date

2025-12-31

Brief Summary

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This trial studies how well a video-based intervention works in helping participants encourage their families to get tested for BRCA gene mutations. Testing in families with BRCA gene mutations can allow for risk management and reduction with the overall goal of reducing cancer burden. Video-based intervention sent via text messages may help participants easily share information about BRCA gene mutations with family members.

Detailed Description

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PRIMARY OBJECTIVES:

I. To understand whether the use of a video-based message to encourage cascade testing, delivered via short message service (SMS) (text message) or shared on social media, is superior to a written message as a method of information-sharing among families that have BRCA gene mutations.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM A: Participants receive a 2-minute information-graphic video via text message consisting of misconceptions and issues that may be paramount when discussing mutation status with relatives that they can share with family via text message, email, or social media.

ARM B: Participants receive family letter via U.S. postal service mail consisting of misconceptions and issues that may be paramount when discussing mutation status with relatives.

Conditions

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BRCA1 Gene Mutation BRCA2 Gene Mutation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Arm A (video via text message)

Participants receive a 2-minute information-graphic video via text message consisting of misconceptions and issues that may be paramount when discussing mutation status with relatives that they can share with family via text message, email, or social media.

Group Type EXPERIMENTAL

Informational Intervention

Intervention Type OTHER

Receive information-graphic video

Survey Administration

Intervention Type OTHER

Ancillary studies

Arm B (letter via standard U.S. mail)

Participants receive family letter via U.S. postal service mail consisting of misconceptions and issues that may be paramount when discussing mutation status with relatives.

Group Type ACTIVE_COMPARATOR

Informational Intervention

Intervention Type OTHER

Receive family letter

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Informational Intervention

Receive information-graphic video

Intervention Type OTHER

Informational Intervention

Receive family letter

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals who test positive for mutations in BRCA1 or BRCA2 are eligible for this study
* Family members who receive the video message/family letter will be invited to participate
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Leigha Senter-Jamieson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Leigha Senter, LGC

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2018-00756

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-17312

Identifier Type: -

Identifier Source: org_study_id

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