Counseling for Hereditary Breast or Ovarian Cancer Risk

Recruiting at 2 trial locations

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Previous GCRA participation

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

Compensation: Varies

Number of Visits: 1

493 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Culturally-Informed Counseling for hereditary breast or ovarian cancer risk?

Research shows that culturally adapting genetic counseling protocols, like telephone genetic counseling, can improve care quality for underserved populations, such as Latina breast cancer survivors. These adaptations help address language and cultural needs, making the counseling more effective and accessible. ^{1 2 3 4 5}

Is counseling for hereditary breast or ovarian cancer risk safe for humans?

The research does not report any safety concerns related to counseling for hereditary breast or ovarian cancer risk. It focuses on improving access and understanding for diverse communities, suggesting it is generally safe for humans. ^{1 2 5 6 7}

What makes Culturally-Informed Counseling unique for hereditary breast or ovarian cancer risk?

Culturally-Informed Counseling is unique because it tailors the counseling process to the cultural background and communication preferences of individuals, particularly focusing on underrepresented groups like Latinas, to improve understanding and access to genetic testing and preventive strategies for hereditary breast and ovarian cancer. ^{2 8 9 10 11}

What is the purpose of this trial?

This pilot clinical trial studies a culturally-informed counseling intervention in Latinas at high risk for hereditary breast or ovarian cancer. A culturally-informed counseling intervention may be an effective method to help people learn more about their cancer risk.

Research Team

Bita Nehoray

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for Latinas at high risk for hereditary breast or ovarian cancer who meet criteria for genetic testing. Participants must understand English or Spanish, be willing to consent, and can include pregnant women. It's aimed at those from low-income communities who are under- or uninsured.

Inclusion Criteria

You have a history of inherited breast or ovarian cancer.

Women who identify as being of Latino or Hispanic background.

Women who do not have health insurance and are from low-income areas

Exclusion Criteria

You have participated in genetic counseling and testing for cancer risk before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-GCRA Intervention

Participants receive a culturally-informed pre-genetic cancer risk assessment (GCRA) telephone intervention

1 week

1 telephone call

Genetic Cancer Risk Assessment (GCRA)

Participants undergo genetic cancer risk assessment

1 week

Follow-up

Participants are monitored for anxiety, perceived personal control, and cancer genetics knowledge

1 week

Treatment Details

Interventions

• Culturally-Informed Counseling
• Educational Intervention
• Questionnaire Administration
• Survey Administration

Trial Overview The study tests a culturally-informed counseling intervention designed to educate high-risk Latina women about their cancer risks. It involves completing questionnaires and surveys, receiving educational materials, and participating in counseling sessions.

Participant Groups

Group I: Arm II Experimental Treatment 3 Interventions

Patients participate in a controlled condition comprising a health habits intervention group.

Group II: Arm I Experimental Treatment 4 Interventions

Patients receive a culturally-informed adapted motivational interviewing telephone call.

Group III: Arm III Active Control 2 Interventions

Patients receive usual care comprising a standard scheduling phone call and proceed with normal GCRA process.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

The workshop emphasized the importance of providing comprehensive testing and counseling services for adults at increased risk of hereditary cancers, specifically breast, ovarian, and colon cancers.

Key recommendations included structured counseling at three critical time points: pretest education, risk notification, and follow-up, to ensure effective communication and support for individuals undergoing genetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Testing and counseling adults for heritable cancer risk. Biesecker, BB., Garber, JE.[2018]

References

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

Effective Referral of Low-Income Women at Risk for Hereditary Breast and Ovarian Cancer to Genetic Counseling: A Randomized Delayed Intervention Control Trial. [2022]

2. 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]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Simultaneous interdisciplinary counseling in German breast/ovarian cancer families: first experiences with patient perceptions, surveillance behavior and acceptance of genetic testing. [2006]

4. Germany pubmed.ncbi.nlm.nih.gov

To worry or not to worry: breast cancer genetic counseling communication with low-income Latina immigrants. [2021]

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. Switzerland pubmed.ncbi.nlm.nih.gov

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

7. Switzerland pubmed.ncbi.nlm.nih.gov

Cancer screening and breast cancer family history in Spanish-speaking Hispanic/Latina women in California. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Barriers and facilitators to BRCA genetic counseling among at-risk Latinas in New York City. [2021]

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

Testing and counseling adults for heritable cancer risk. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Guidelines for evaluation of patients at risk for inherited breast and ovarian cancer: recommendations of the Department of Defense Familial Breast/Ovarian Cancer Research Project. [2017]

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

Management of genetic syndromes predisposing to gynecologic cancers. [2022]