Educational Video + Fact Sheet for Breast and Ovarian Cancer Risk Awareness

Recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Georgetown University

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

Compensation: Varies

Number of Visits: 1

332 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a special video in Spanish against a simple information sheet to help Latina women at risk for breast and ovarian cancer understand genetic counseling and testing. The video is designed to connect emotionally and culturally with the women, making them more likely to take action. The study will see which method works better and how it can be used in community clinics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on educational materials and genetic counseling, so it's unlikely that medication changes are required.

What data supports the effectiveness of the treatment Culturally Targeted Narrative Video: 'Is My Cancer Hereditary? Rosa Visits a Genetic Counselor.' for increasing awareness of breast and ovarian cancer risk?

Research shows that a culturally targeted video significantly improved knowledge, positive attitudes, and intentions to participate in genetic counseling among Latina women at risk for hereditary breast and ovarian cancer. This suggests that the video can effectively raise awareness and encourage participation in genetic counseling services. ^{1 2 3 4 5}

Is the educational video and fact sheet for breast and ovarian cancer risk awareness safe for humans?

The educational video and fact sheet have been used in studies with Latina women at risk for hereditary breast and ovarian cancer, and no safety concerns have been reported. The video was well-received and improved knowledge and attitudes without any noted adverse effects. ^{1 2 3 4 6}

How does the treatment 'Culturally Targeted Narrative Video: 'Is My Cancer Hereditary? Rosa Visits a Genetic Counselor.' differ from other treatments for breast and ovarian cancer risk awareness?

This treatment is unique because it uses a culturally targeted narrative video specifically designed to improve genetic counseling uptake among Latina women at risk for hereditary breast and ovarian cancer. It addresses disparities in awareness and access by using simple language and visual aids, making it accessible to underserved populations with low literacy and English proficiency. ^{1 2 3 6 7}

Research Team

Alejandra Hurtado de Mendoza, Ph.D

Principal Investigator

Georgetown Lombardi Comprehensive Cancer Center

Eligibility Criteria

This trial is for Latina women who are at least 18 years old, fluent in Spanish, and have not been involved in previous HBOC or GCT studies. They should meet the NCCN criteria for genetic cancer risk assessment due to personal or family history but haven't undergone genetic counseling or testing for hereditary breast and ovarian cancer.

Inclusion Criteria

No other family members are participating in this study

I identify as a Latina woman.

I work or volunteer at the partner community clinic.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants are randomized to either watch a culturally targeted narrative video or read a fact sheet about HBOC and genetic services

2 weeks

1 visit (in-person or virtual)

Follow-up

Participants are monitored for changes in subjective norms, beliefs, attitudes, and uptake of genetic counseling and testing

4 months

Implementation Evaluation

Community clinic staff participate in focus groups to assess the implementation outcomes of integrating HBOC screening practices

48 months

Treatment Details

Interventions

• Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor."
• FORCE Fact Sheet

Trial Overview The study compares a culturally targeted video about hereditary breast and ovarian cancer (HBOC) with a Spanish-language fact sheet to see which is more effective at encouraging Latinas to get genetic counseling and testing. It also evaluates how well these tools can be implemented in community clinics.

Participant Groups

Group I: Video Arm Experimental Treatment 1 Intervention

Culturally Targeted Narrative Video: "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor." Participants in the video arm will be asked to watch an 18-minute video that the research team developed and tested previously about HBOC and genetic services. The video is recorded with Spanish audio and is available with English subtitles.

Group II: Fact Sheet Arm Active Control 1 Intervention

Participants in the Fact Sheet arm will receive a Fact sheet about HBOC and genetic services and will be asked to read it in their own time. The Fact Sheet is available in English and Spanish.

Who Is Running the Clinical Trial?

Georgetown University

Lead Sponsor

Trials

355

Recruited

142,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Virginia Commonwealth University

Collaborator

Trials

732

Recruited

22,900,000+

References

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

Exploring attitudes, beliefs, and communication preferences of Latino community members regarding BRCA1/2 mutation testing and preventive strategies. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Culturally Targeted Video Improves Psychosocial Outcomes in Latina Women at Risk of Hereditary Breast and Ovarian Cancer. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Developing a culturally targeted video to enhance the use of genetic counseling in Latina women at increased risk for hereditary breast and ovarian cancer. [2021]

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

Development of a culturally sensitive narrative intervention to promote genetic counseling among African American women at risk for hereditary breast cancer. [2023]

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

Cultural adaptations to a telephone genetic counseling protocol and booklet for Latina breast cancer survivors at risk for hereditary breast and ovarian cancer. [2023]

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

Women's perceptions of the personal and family impact of genetic cancer risk assessment: focus group findings. [2021]

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

Awareness and concern about ovarian cancer among women at risk because of a family history of breast or ovarian cancer. [2019]