Provider Communication for Cancer Risk Gene Testing

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Informed consent, Genetic testing, others

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

Compensation: Varies

Number of Visits: Unknown

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if healthcare providers directly communicating genetic test results to family members of cancer patients can enhance genetic counseling and testing among those at risk. Approximately 15% of people with cancer have inherited gene changes that increase their risk, but many remain unaware due to the limited reach of genetic counseling. The study compares usual care, where patients inform their at-risk relatives, with an approach called Provider-Mediated Communication of Genetic Testing Results to At-Risk Relatives of Cancer Patients, where healthcare providers also contact the relatives. This trial suits individuals who have undergone genetic testing at City of Hope, have a known inherited cancer gene change, and have two or more first-degree relatives in the U.S. who have not yet been tested. As an unphased trial, this study offers a unique opportunity to contribute to innovative approaches in genetic counseling and testing.

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 is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that provider-mediated communication is safe for improving genetic counseling and testing rates?

Research shows that when healthcare providers share genetic test results, family members at risk for cancer can better understand their risk and take action. This trial tests a communication method, not a new drug or treatment, so there are no direct safety risks involved.

Previous studies found that direct contact from healthcare providers to at-risk family members can be helpful. These studies examined the effectiveness of this method and reported no safety concerns, as it primarily involves sharing information. Therefore, potential participants can feel reassured that the safety risk is very low, given the nature of the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores new ways to communicate genetic testing results to families at risk for cancer. Unlike the usual approach, where patients receive a letter and test report to share with relatives, this trial includes a method where healthcare providers also directly contact relatives to discuss the results. This provider-mediated contact could improve understanding and encourage proactive health decisions among family members. The hope is that this approach will lead to better communication and ultimately help at-risk relatives make more informed choices about their health.

What evidence suggests that provider-mediated communication is effective for improving genetic counseling and testing rates?

This trial will compare two methods for communicating genetic testing results to at-risk relatives of cancer patients. Research has shown that direct communication from healthcare providers leads more relatives to undergo genetic testing. Specifically, about 64.9% of relatives got tested when contacted by a healthcare provider, compared to 54.4% when family members relayed the information. Studies have found that healthcare providers sharing results boosts relatives' confidence and understanding, resulting in more frequent genetic counseling. This approach helps more people learn about their risk and receive necessary care. ^{1 4 5 6 7}

Who Is on the Research Team?

Stacy W. Gray

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults in the U.S. who have a known harmful gene change linked to cancer, seen by COH Genetics, and are willing to share contact info of their relatives. Relatives must also be adults in the U.S., fluent in English, and not previously tested for this genetic variant.

Inclusion Criteria

Patients are fluent in English

Patients are willing to provide contact information for eligible first-degree relatives

First-degree relatives reside within the United States

Exclusion Criteria

First-degree relatives are unable or unwilling to provide informed consent

I have less than 2 close family members in the US eligible for genetic testing.

First-degree relatives reside outside of the United States

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a family letter and genomic test report to share with at-risk relatives. In Arm II, relatives also receive provider-mediated contact to discuss genetic results.

Up to 9 months

Follow-up

Participants are monitored for the uptake of cascade testing among at-risk relatives and the psychosocial impact of provider-mediated contact.

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Provider-Mediated Communication of Genetic Testing Results to At-Risk Relatives of Cancer Patients

Trial Overview The study examines if healthcare providers can help increase genetic counseling and testing rates among at-risk family members by directly communicating genetic test results instead of relying on patients to pass along this information.

How Is the Trial Designed?

Group I: Arm II (provider-mediated contact) Experimental Treatment 3 Interventions

Patients receive a family letter and their genomic test report to share with at-risk first degree relatives and relatives also receive provider-mediated contact to discuss genetic results on study.

Group II: Arm I (usual care) Active Control 3 Interventions

Patients receive a family letter and their genomic test report to share with at-risk first degree relatives on study.

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

In a study analyzing 656 genetic counseling summary notes for breast cancer genes, 92.2% documented cascade genetic testing, highlighting its importance in family communication about pathogenic variants.

Genetic counselors were more likely to include specific risk messaging in notes for high-risk genes and when mentioning relatives, indicating a focus on effective communication strategies to facilitate genetic testing among family members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Disclosure of familial implications of pathogenic variants in breast-cancer genes to patients: Opportunity for prompting family communication. Makhnoon, S., Smith, HS., Bednar, EM., et al.[2021]

A study involving 25 patients with hereditary cancer revealed that while most patients (80%) shared their genetic testing results with relatives, many relatives did not pursue cascade genetic testing (CGT) due to low perceived susceptibility to hereditary cancer.

Relatives expressed distress upon learning about the patient's genetic test results and were fearful of their own potential results, highlighting the need for tailored resources to support families in understanding hereditary cancer risks and improving communication about CGT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of Family Communication and Cascade Genetic Testing for Hereditary Cancer in Medically Underserved Populations-A Qualitative Study. Bednar, EM., Rauh-Hain, JA., Garcia, JJ., et al.[2023]

A study involving 561 first-degree relatives of individuals who underwent BRCA1/2 genetic testing found that 82.1% correctly understood the test results, indicating a generally high level of comprehension among family members.

Despite understanding the results, many relatives experienced distress, especially when the results were informative, and showed low intention to pursue further genetic counseling or testing, highlighting the need for improved communication strategies within families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating genetic test results within the family: Is it lost in translation? A survey of relatives in the randomized six-step study. Daly, MB., Montgomery, S., Bingler, R., et al.[2018]

Effective communication of cancer risk information is crucial not only for those undergoing genetic testing but also for individuals who may not be eligible or interested in testing, highlighting the broader relevance of risk information.

A synthesis of 75 research reports and expert opinions has led to recommendations aimed at improving the knowledge and practices of various health professionals involved in communicating cancer risk, ensuring that accurate information is shared effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communicating cancer risk information: the challenges of uncertainty. Bottorff, JL., Ratner, PA., Johnson, JL., et al.[2019]

In a study of 100 recently diagnosed breast cancer patients, 77 pursued BRCA genetic testing, with most sharing results with female first-degree relatives and their oncologists, but less so with male relatives or other healthcare providers.

The findings indicate a need for better education and support for patients to improve communication of BRCA test results to all first-degree relatives and various healthcare professionals, ensuring comprehensive risk management for families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do Breast Cancer Patients Tested in the Oncology Care Setting Share BRCA Mutation Results with Family Members and Health Care Providers? Vadaparampil, ST., Malo, T., de la Cruz, C., et al.[2021]

In a study involving 279 participants from the eMERGE-3 study, only 34% shared their genomic screening results with all first-degree relatives within 6 months, highlighting a significant gap in communication of important health information.

Participants who received results from genetics providers were more likely to share them (53%) compared to those who received results from non-genetics providers (11%), indicating that the source of information plays a crucial role in family communication practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Do research participants share genomic screening results with family members? Wynn, J., Milo Rasouly, H., Vasquez-Loarte, T., et al.[2022]

The FamilyCONNECT tool was developed to help patients with Lynch Syndrome (LS) communicate genetic risk information to at-risk relatives, and it received positive feedback from 79% of survey respondents, indicating its potential effectiveness.

Key barriers to using FamilyCONNECT identified by genetics professionals included concerns about privacy and confidentiality (83%) and a lack of institutional resources (76%), suggesting that addressing these issues is crucial for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of an online, patient-driven, family outreach intervention to facilitate sharing of genetic risk information in families with Lynch syndrome. Pande, M., Peterson, S., Lynch, PM.[2022]

A qualitative study involving focus groups and interviews with patients at risk for hereditary cancer syndromes revealed that direct contact by health systems to recommend genetic testing for relatives is acceptable and beneficial.

The study suggests that such programs should prioritize consent from relatives, complement existing disclosure methods, and allow relatives to control their information, potentially increasing the number of individuals who benefit from genetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Family Preferences on Health System-Led Direct Contact for Cascade Screening. Henrikson, NB., Blasi, P., Figueroa Gray, M., et al.[2021]

A study involving 1,721 cancer patients revealed that most intended to share their positive genetic test results with close family members, indicating a strong desire for familial support in the context of cancer risk.

Factors such as familial support and communication skills significantly influenced patients' intentions to share their genetic test results, suggesting that healthcare providers should consider these dynamics when encouraging patients to discuss their results with relatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors that Influence Intent to Share Genetic Information Related to Cancer Risk with Family Members. Stuttgen Finn, K., Pacyna, JE., Tsou, C., et al.[2022]

Health-care professionals actively support consultands in communicating genetic risk information to their relatives, which is essential for maximizing the benefits of genetic health care.

Three main strategies were identified: direct outreach from genetic services to relatives, encouragement for consultands to share information, and providing tools like psychoeducational guidance and written aids to facilitate communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How communication of genetic information within the family is addressed in genetic counselling: a systematic review of research evidence. Mendes, Á., Paneque, M., Sousa, L., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05772130

Provider-Mediated Communication of Genetic Testing ... Provider-mediated contact to discuss genetic test results may help improve rates of genetic testing among at-risk relatives of patients with a family cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4009372/

Communication of Genetic Test Results to Family and ... Among carriers, >74% reported communicating results to family; communication was predicted by baseline confidence in coping with the genetic test result (Z=1.97 ...

3. nature.com nature.com/articles/s41431-025-01922-w

Direct letters to relatives at risk of hereditary cancer—a ... Observational studies suggest that direct contact from healthcare to at-risk relatives may increase genetic counselling (GC) uptake as ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1098360021017202

Communication of genetic test results to family and health ... After disclosure, 54% reported screening for any type of cancer. Among carriers, >74% reported communicating results to family; communication was predicted by ...

5. mdpi.com mdpi.com/2072-6694/16/8/1577

National Experiences from 30 Years of Provider-Mediated ... Overall uptake of genetic testing was 54.4% after family-mediated and 64.9% after provider-mediated contact by letter. The uptake of genetic ...

6. withpower.com withpower.com/trial/provider-communication-for-cancer-risk-gene-testing-b78b8

Provider Communication for Cancer Risk Gene Testing This clinical trial tests whether provider-mediated communication of genetic testing results to at-risk relatives of cancer patients can help improve ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9409642/

The Communication Chain of Genetic Risk This study focused on proband-mediated communication of genetic risk by exploring the “communication chain” from probands' perspective, namely how genetic ...