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

BRCAShare: Video Intervention for Relatives of BRCA Mutation-Positive Patients

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.

Study Overview

• Status: Completed
• Conditions: BRCA1 Gene Mutation; BRCA2 Gene Mutation
• Intervention / Treatment: Other: Survey Administration; Other: Informational Intervention; Other: Informational Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Survey Administration; Ancillary studies; Other: Informational Intervention; Receive information-graphic video; Other: Informational Intervention; Receive family letter
Active Comparator: 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.	Other: Survey Administration; Ancillary studies; Other: Informational Intervention; Receive information-graphic video; Other: Informational Intervention; Receive family letter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of a web-based video delivered via text message or shared on social media on information sharing among relatives belonging to families with BRCA gene mutations	Measure participant-reported information sharing among family members prior to receipt of the video and after the video. There is no previously validated scale/set of items for this. Items are investigator created and assess likelihood to share information with family members on a Likert scale.	Up to 3 years
Impact of participant-reported family dynamics on information sharing	Brief family relationship scale will be used to determine whether differences in family dynamics could be associated with differences in family sharing. A higher score for the cohesion and expressiveness subscales generally indicates more positive dynamics and a the conflict subscale is inversely scored.	Up to 3 years

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Leigha Senter, LGC, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2018
• Primary Completion (Actual): June 7, 2025
• Study Completion (Actual): June 7, 2025

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: March 2, 2022
• First Posted (Actual): March 3, 2022

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: OSU-17312; NCI-2018-00756 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No