Counseling for Hereditary Breast or Ovarian Cancer Risk

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how culturally-informed counseling might help Latina women understand their risk of hereditary breast or ovarian cancer. Participants will be divided into groups: some will receive a special counseling intervention, while others will follow regular care practices. The trial seeks Latina women who have or are at high risk for hereditary breast or ovarian cancer, especially those who are under- or uninsured. Participants should be comfortable communicating in either English or Spanish. This research could provide valuable insights into effective communication strategies for managing cancer risk.

As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance cancer risk communication 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.

What prior data suggests that this counseling intervention is safe?

Research has shown that counseling tailored to cultural needs is generally well-received and safe. A small initial study found that Black women at risk for hereditary breast cancer were very satisfied with a decision-making tool designed for them. This suggests that similar counseling methods, like the one under study, are likely to be well-accepted.

Although this study phase doesn't directly test safety, culturally-informed counseling is non-invasive. It doesn't involve medical procedures or medication, which usually makes it safer. Available studies have reported no negative effects from such counseling. Overall, focusing on cultural understanding in counseling helps people learn about their cancer risk in a supportive environment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores culturally-informed counseling methods for hereditary breast or ovarian cancer risk. Unlike standard options, which often involve routine genetic counseling, this trial tests a personalized approach that considers cultural backgrounds to deliver motivational interviewing via telephone. This can potentially enhance patient engagement and adherence by making the counseling more relatable and effective for diverse populations. By tailoring the counseling experience, this trial aims to uncover how cultural sensitivity can improve outcomes in genetic risk management.

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

This trial will compare different counseling approaches for hereditary breast or ovarian cancer risk. Research has shown that culturally respectful counseling can help individuals understand their hereditary cancer risk. Participants in Arm I will receive a culturally-informed adapted motivational interviewing telephone call. Studies have found that this type of counseling increases satisfaction and motivation among women at risk for hereditary breast and ovarian cancer. For instance, Latina breast cancer survivors have responded well to changes in counseling methods. This approach makes the information more relatable and understandable, leading to better participation in genetic counseling. Overall, culturally-sensitive counseling appears promising in improving awareness and decision-making about cancer risks. ^{1 3 4 6 7}

Who Is on the Research Team?

Bita Nehoray

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9233847/

Pilot study of a culturally sensitive intervention to promote ... This study demonstrated cultural satisfaction with a decision aid intervention designed to motivate Black women with hereditary breast cancer risk to attend a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10182423/

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

3. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.1002/cncr.33525

Development of a culturally sensitive narrative intervention to ... A culturally sensitive multimedia narrative intervention was developed to motivate African American women at risk for hereditary breast cancer ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S109836002102092X

Article Exploring attitudes, beliefs, and communication ... Purpose. To inform development of a culturally sensitive hereditary breast and ovarian cancer communication initiative and related clinical genetic services.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1098360023009966

Systematic evidence review and meta-analysis of ... We conducted a systematic review and meta-analysis of 17 patient-reported and health-services-related outcomes associated with pre- and post-test GC in GCRA.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3022322/

Exploring attitudes, beliefs, and communication preferences of ... This research suggests that cancer genetic communication efforts should consider community and cultural perspectives as well as health care access issues.

7. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1306388/full

The history of families at-risk for hereditary breast and ... The genogram analyses revealed the impact of CGC and GT processes on families at risk for hereditary cancer. Changes in some family ...