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

Recruiting at 2 trial locations

Overseen By Alejandra Hurtado de Mendoza, Ph.D

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Georgetown University

Disqualifiers: Previous genetic counseling, others

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

Compensation: Varies

Number of Visits: 1

332 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of a culturally targeted video with a Spanish-language fact sheet in encouraging Latina women to seek genetic counseling and testing for hereditary breast and ovarian cancer. The study will test two approaches: watching an 18-minute video titled "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor" or reading a FORCE Fact Sheet, both designed to increase awareness and understanding of genetic risks. Latina women who speak Spanish and have a personal or family history of cancer but have not yet participated in genetic counseling or testing are ideal candidates for this trial. As an unphased study, this trial offers participants the opportunity to contribute to important research that could enhance genetic counseling outreach and education for Latina women.

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 prior data suggests that this video and fact sheet are safe for use in this trial?

Research shows that the culturally focused video is safe for viewers. In past studies, this video helped people understand breast and ovarian cancer risks without causing harm. It shares the story of Rosa, a Latina breast cancer survivor, to educate viewers about genetic counseling and testing. Previous tests revealed no negative effects. Designed to be informative and supportive, the video aims to increase awareness and education among Latina women. It is safe to watch and helps viewers make informed health decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these educational tools for breast and ovarian cancer risk awareness because they could make understanding genetic risks much more accessible. Unlike traditional methods that might involve dense medical literature or in-person consultations, the narrative video is designed to engage viewers through a relatable story, available in Spanish with English subtitles, making it more inclusive. The fact sheet, available in both English and Spanish, provides straightforward information that participants can digest at their own pace. This approach could empower more people to understand their hereditary cancer risks and seek appropriate genetic counseling and testing.

What evidence suggests that this trial's treatments could be effective for hereditary breast and ovarian cancer risk awareness?

Studies have shown that culturally tailored videos can enhance understanding and engagement with healthcare. In this trial, participants in the Video Arm will watch "Is My Cancer Hereditary? Rosa Visits a Genetic Counselor," a video created specifically for Latina women. Research indicates that this video helps viewers understand their risk for hereditary breast and ovarian cancer (HBOC) and encourages them to seek genetic counseling. The video follows Rosa, a Latina breast cancer survivor, as she learns about her risk and takes action. This approach has effectively raised awareness and improved access to genetic services. ^{1 2 3 4 5}

Who Is on the Research Team?

Alejandra Hurtado de Mendoza, Ph.D

Principal Investigator

Georgetown Lombardi Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. researchgate.net researchgate.net/publication/333197248_Developing_a_culturally_targeted_video_to_enhance_the_use_of_genetic_counseling_in_Latina_women_at_increased_risk_for_hereditary_breast_and_ovarian_cancer

(PDF) Developing a culturally targeted video to enhance ... The result was an 18-min video that illustrates “Rosa's” story. Rosa learns about HBOC risk factors and overcomes barriers to attend genetic ...

2. withpower.com withpower.com/trial/phase-ovarian-neoplasms-5-2021-70892

Educational Video + Fact Sheet for Breast and Ovarian ... This treatment is unique because it uses a culturally targeted narrative video specifically designed to improve genetic counseling uptake among Latina women at ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6926842/

Culturally Targeted Video Improves Psychosocial Outcomes in ... The 18 min video illustrates the GCT process with the story of Rosa, a Latina breast cancer survivor who learns about her risk for HBOC, overcomes barriers to ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10226534/

Process evaluation of a culturally targeted video for Latinas at ... The video tells the story of Rosa, a Latina breast cancer survivor who learns about her risk of carrying a variant associated with HBOC and wants to make a ...

5. link.springer.com link.springer.com/article/10.1007/s12687-024-00728-5

Raising awareness and education of genetic testing ... This 18-minute video shows a story about Rosa, a Latina and breast cancer survivor diagnosed under 50 years of age. Rosa learns about her risk ...