NCT05264532

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

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

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

April 5, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2018

Completed
3.7 years until next milestone

First Posted

Study publicly available on registry

March 3, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2025

Completed
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

7.2 years

First QC Date

June 25, 2018

Last Update Submit

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)

EXPERIMENTAL

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: Informational InterventionOther: Survey Administration

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

ACTIVE COMPARATOR

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: Informational InterventionOther: Survey Administration

Interventions

Ancillary studies

Arm A (video via text message)Arm B (letter via standard U.S. mail)

Receive information-graphic video

Arm A (video via text message)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Location

Related Links

Study Officials

  • Leigha Senter, LGC

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

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

Locations