What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy, radiation therapy, hormone therapy, and targeted therapy, can cause side effects including fatigue, nausea, hair loss, hot flashes, and increased risk of infections. For ovarian cancer, treatments like surgery and chemotherapy can lead to side effects such as pain, fatigue, nausea, and increased risk of infections. Both cancers may also involve targeted therapies, which can cause side effects like skin rashes, diarrhea, and liver problems. These side effects can vary in intensity and duration depending on the individual and specific treatment regimen.

What prior FDA approvals exist?

The FDA has approved several treatments for breast and ovarian cancer that are relevant to genetic counseling and testing. For breast cancer, PARP inhibitors like olaparib and talazoparib have been approved for patients with BRCA mutations. Similarly, for ovarian cancer, PARP inhibitors such as rucaparib, niraparib, and olaparib are approved for patients with BRCA mutations or homologous recombination deficiencies. These approvals highlight the importance of genetic testing in identifying patients who may benefit from targeted therapies.

What other types of research exist?

Promising alternatives to culturally-targeted videos for enhancing genetic counseling and testing uptake and improving psychosocial outcomes in breast and ovarian cancer patients include: 1) Interactive computer programs, which have been shown to increase knowledge about breast cancer and genetic testing. 2) Online genetic counseling, which has demonstrated comparable patient satisfaction, anxiety reduction, and perceived control to in-person counseling. 3) Group-based psychosocial care via videoconference, which has been found feasible and acceptable, particularly for mindfulness training and psychoeducation.

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

N/A

Waitlist Available

Led By Alejandra Hurtado de Mendoza, Ph.D

Research Sponsored by Georgetown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-identify as a Latina woman

Be fluent in English or Spanish

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the post implementation focus groups with community clinics adoption over the previous 48 months will be assessed

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves educational materials rather than medical treatments, there are no direct physical side effects expected from participating. However, learning about one's potential cancer risks could cause emotional or psychological distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I identify as a Latina woman.

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I am fluent in either English or Spanish.

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I have never had genetic counseling or testing for breast and ovarian cancer risk.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from the baseline survey to four months after baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from the baseline survey to four months after baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from the baseline survey to four months after baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Uptake of Genetic Counseling

Uptake of Genetic Testing

Secondary study objectives

Acceptability of the intervention

Anticipatory emotions about genetic cancer risk assessment

Beliefs and Attitudes about genetic cancer risk assessment

+4 more

Other study objectives

Acceptability of the Referral Screening Tool

Adoption of the Referral Screening Tool

Feasibility of the Referral Screening Tool

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Video ArmExperimental Treatment1 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 ArmActive Control1 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.

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast and ovarian cancer include surgery, chemotherapy, radiation therapy, hormone therapy, and targeted therapy. Surgery involves the physical removal of tumors, while chemotherapy uses drugs to kill rapidly dividing cancer cells. Radiation therapy employs high-energy rays to destroy cancer cells. Hormone therapy blocks hormones like estrogen that can promote cancer growth, and targeted therapy uses drugs to target specific molecules involved in cancer cell growth and survival. Understanding these mechanisms is crucial for patients as it helps them make informed decisions about their treatment options. Additionally, genetic counseling and testing can identify individuals at higher risk for hereditary cancers, allowing for personalized treatment plans and preventive measures.

Use of Video Education Interventions to Increase Racial and Ethnic Diversity in Cancer Clinical Trials: A Systematic Review.A Pilot Study to Determine the Effect of an Educational DVD in Philippine Languages on Cancer Clinical Trial Participation among Filipinos in Hawai'i.YouTube Videos as a Source of Information About Clinical Trials: Observational Study.