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

58 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Video-Based Intervention for BRCA Gene Mutations?

Research shows that video-based interventions can reinforce information and improve efficiency in genetic counseling, making them a useful tool for educating patients about BRCA gene mutations. ^{1 2 3 4 5}

Is the Video-Based Intervention for BRCA Gene Mutations safe for humans?

The research articles do not provide specific safety data for the Video-Based Intervention for BRCA Gene Mutations. However, they suggest that video-based educational tools are generally well-received and can effectively increase knowledge about genetic testing without mentioning any safety concerns. ^{6 7 8 9 10}

How does the Video-Based Intervention treatment for BRCA gene mutations differ from other treatments?

The Video-Based Intervention for BRCA gene mutations is unique because it uses video content to educate patients about genetic testing and its implications, which can enhance understanding and recall of information. Unlike traditional methods, this approach leverages the accessibility and widespread use of platforms like YouTube to reach a broader audience, making it a novel tool for patient education and engagement. ^{1 7 10 11 12}

Research Team

Leigha Senter, LGC

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Assessment of the use and feasibility of video to supplement the genetic counseling process: a cancer genetic counseling perspective. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Are videoconferenced consultations as effective as face-to-face consultations for hereditary breast and ovarian cancer genetic counseling? [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Video-assisted genetic counseling in patients with ovarian, fallopian and peritoneal carcinoma. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Psychosocial Interventions for Women with a BRCA1 or BRCA2 Mutation: A Scoping Review. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Inadequate Rates of BRCA Testing with its Negative Consequences for Women with Epithelial Ovarian Cancer and their Families: an Overview of the Literature. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Inherited Cancer Knowledge Among Black Females with Breast Cancer Before and After Viewing a Web-Based Educational Video. [2023]

7. Germany pubmed.ncbi.nlm.nih.gov

YouTube as an information source on BRCA mutations: implications for patients and professionals. [2022]

8. Switzerland 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. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Controversies in communication of genetic risk for hereditary breast cancer. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Developing video education materials for the return of genomic test results to parents and adolescents. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

The impact of a cascade testing video on recipients' knowledge, cognitive message processing, and affective reactions: A formative evaluation. [2021]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Developing and assessing the utility of a You-Tube based clinical genetics video channel for families affected by inherited tumours. [2018]