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
2 other identifiers
interventional
58
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 5, 2018
CompletedFirst Submitted
Initial submission to the registry
June 25, 2018
CompletedFirst Posted
Study publicly available on registry
March 3, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2025
CompletedFebruary 10, 2026
February 1, 2026
7.2 years
June 25, 2018
February 6, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Arm A (video via text message)
EXPERIMENTALParticipants 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 (letter via standard U.S. mail)
ACTIVE COMPARATORParticipants receive family letter via U.S. postal service mail consisting of misconceptions and issues that may be paramount when discussing mutation status with relatives.
Interventions
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Leigha Senter, LGC
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 25, 2018
First Posted
March 3, 2022
Study Start
April 5, 2018
Primary Completion
June 7, 2025
Study Completion
June 7, 2025
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share