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

Sponsor
Ohio State University Comprehensive Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05264532
Collaborator
(none)
200
1
2
68.9
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Informational Intervention
  • Other: Informational Intervention
  • Other: Survey Administration
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
BRCAShare: Video Intervention for Relatives of BRCA Mutation-Positive Patients
Actual Study Start Date :
Apr 5, 2018
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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: Informational Intervention
Receive information-graphic video

Other: Survey Administration
Ancillary studies

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: Informational Intervention
Receive family letter

Other: Survey Administration
Ancillary studies

Outcome Measures

Primary Outcome Measures

  1. 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 [Up to 3 years]

    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.

  2. Impact of participant-reported family dynamics on information sharing [Up to 3 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210

Sponsors and Collaborators

  • Ohio State University Comprehensive Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Leigha Senter-Jamieson, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT05264532
Other Study ID Numbers:
  • OSU-17312
  • NCI-2018-00756
First Posted:
Mar 3, 2022
Last Update Posted:
Mar 3, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Mar 3, 2022