Video-Based Intervention for BRCA Gene Mutations

Overseen By The Ohio State University Comprehsensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: No BRCA mutation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a video sent by text can help individuals with BRCA gene mutations encourage their families to undergo testing. The goal is to simplify understanding of the risks and facilitate discussions about testing, which can aid in managing and reducing cancer risk. Participants will receive either a short video (video-based intervention) or a letter containing important information to share with their relatives. This trial suits individuals who have tested positive for the BRCA1 or BRCA2 gene mutations and wish to inform their family. As an unphased study, this trial offers a unique opportunity to contribute to research that could simplify family communication about genetic risks.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this video-based intervention is safe?

Research shows that video-based programs are generally well-received and have been used safely in many situations. Although specific safety details for the video program in this BRCA gene mutation study are unavailable, similar programs have proven successful and satisfying in other areas. These programs typically share information through videos, which is non-invasive and poses no physical risks to participants. Therefore, participating in this trial and receiving information through video messages is likely safe and comfortable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the video-based intervention for BRCA gene mutations because it uses modern communication methods to facilitate family discussions about genetic risks. Unlike traditional approaches that often involve genetic counseling sessions or mailed letters, this intervention delivers a concise, 2-minute video via text message. This allows participants to easily share crucial information with relatives through text, email, or social media, making it more accessible and engaging. By using familiar digital platforms, the intervention could improve the dissemination of important health information and potentially increase the understanding and communication of BRCA mutation status within families.

What evidence suggests that this trial's interventions could be effective for encouraging family testing for BRCA gene mutations?

Research shows that videos can help people discuss BRCA gene mutations with their families. Since BRCA mutations can increase the risk of certain cancers, family members should consider testing. In this trial, participants in one arm will receive a 2-minute infographic video via text message to share with family. Studies have found that videos simplify complex information, making it easier to understand and share. This might encourage more people to get tested, which is crucial for managing cancer risk. Although researchers are still exploring the use of videos in this context, they have succeeded in other health education areas, making them a promising tool here. ^{1 2 5 6 7}

Who Is on the Research Team?

Leigha Senter, LGC

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals who have tested positive for BRCA1 or BRCA2 gene mutations. It's designed to see if they can encourage their family members to get tested too, using a video-based intervention sent via text.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either a video-based message via text or a family letter via mail to encourage information sharing about BRCA gene mutations

Immediate

Follow-up

Participants are monitored for the impact of the intervention on information sharing and family dynamics

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Video-Based Intervention

Trial Overview The study is testing the effectiveness of a video message intervention in motivating family members of participants with BRCA gene mutations to undergo genetic testing, potentially aiding in cancer prevention and risk management.

How Is the Trial Designed?

Group I: Arm A (video via text message) Experimental Treatment 2 Interventions

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.

Group II: Arm B (letter via standard U.S. mail) Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

Only 30% of cancer genetic counselors currently use educational videos for patient education, citing benefits like reinforcing information and improving efficiency, while 70% do not use them due to barriers such as lack of appropriate content and concerns about the impersonal nature of videos.

Counselors expressed a strong interest in videos that accurately represent genetic counseling sessions and include critical content such as the pros and cons of genetic testing, psychosocial implications, and issues of genetic discrimination.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the use and feasibility of video to supplement the genetic counseling process: a cancer genetic counseling perspective. Axilbund, JE., Hamby, LA., Thompson, DB., et al.[2018]

The Family Gene Toolkit, a customized web application for families with BRCA1/BRCA2 pathogenic variants, was developed based on feedback from 68 women and is designed to improve family communication about genetic testing results.

In a usability test with 18 women, participants reported high satisfaction with the toolkit, finding it useful for coping strategies and family communication, indicating its potential to promote cascade genetic testing among at-risk relatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability and Usability of the Family Gene Toolkit for Swiss and Korean Families Harboring BRCA1/BRAC2 Pathogenic Variants: A Web-Based Platform for Cascade Genetic Testing. Baroutsou, V., Duong, V., Signorini, A., et al.[2023]

There is a growing demand for breast cancer risk assessment due to increased awareness of genetic factors, highlighting the need for effective communication methods for conveying complex genetic information to consumers and their families.

Research is needed to evaluate the psychosocial and behavioral outcomes of web- and telephone-based genetic services, especially regarding how to communicate risks to at-risk relatives, including minors, to ensure effective risk management and support for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Controversies in communication of genetic risk for hereditary breast cancer. Mackenzie, A., Patrick-Miller, L., Bradbury, AR.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05264532?term=AREA%5BConditionSearch%5D((FANCONI%20ANEMIA,%20COMPLEMENTATION%20GROUP%20S)%20OR%20(BRCA1))&rank=9

Study Details | Usefulness of Video-Based Intervention in ... This trial studies how well a video-based intervention works in helping participants encourage their families to get tested for BRCA gene mutations. Testing ...

2. withpower.com withpower.com/trial/phase-brca2-gene-mutation-3-2018-84923

Video-Based Intervention for BRCA Gene Mutations This trial studies how well a video-based intervention works in helping participants encourage their families to get tested for BRCA gene mutations.

3. karger.com karger.com/phg/article/25/5-6/141/821162/Evaluating-the-Effectiveness-of-a-Telehealth

Evaluating the Effectiveness of a Telehealth Cancer ... About 1 in 40 (2.5%) AJ individuals carry a BRCA mutation, which is tenfold the carrier rate of the general population [5, 6]. Two founder ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7278068/

Implementation and evaluation of a nurse-led decision ... The EDCP-BRCA study is the first study to implement and evaluate decision coaching combined with a decision aid for healthy BRCA mutation carriers worldwide.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1098360025002205

Implementing interventions to increase genetic testing for ... Based on reported study aims and research questions, studies were categorized according to 3 types of hybrid effectiveness-implementation designs: type 1 ( ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12060740/

Understanding Breast Cancer (BRCA) Mutations Through ... This study aims to explore content on TikTok related to BRCA mutations and assess its impact on public awareness and physician involvement.

7. ctv.veeva.com ctv.veeva.com/study/usefulness-of-video-based-intervention-in-helping-participants-encourage-their-families-to-get-teste

Usefulness of Video-Based Intervention in Helping ... This trial studies how well a video-based intervention works in helping participants encourage their families to get tested for BRCA gene ...