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

BRCA1 Gene Mutation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05264532
• Other study ID #: OSU-17312
• Secondary ID: NCI-2018-00756
• Status: Recruiting
• Phase: N/A
• Start date: April 5, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Ohio State University Comprehensive Cancer Center
• Contact: The Ohio State University Comprehsensive Cancer Center
• Phone: 1-800-293-5066
• Email: OSUCCCClinicaltrial[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• BRCA1 Gene Mutation
• BRCA2 Gene Mutation

Intervention

Other:
• Informational Intervention
Receive information-graphic video
• Informational Intervention
Receive family letter
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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

External Links

•   The Jamesline