Genetic Counseling for Cancer

(GIFT Trial)

Enrolling by invitation at 3 trial locations

Overseen By Steven Katz, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Disqualifiers: Age<18, No genetic testing, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist cancer patients in discussing the risk of inherited cancer genes with their family members and provides support for genetic testing. It evaluates a program called GIFT (Genetic Information Family Testing), which helps families understand their genetic risks and guides them in discussing cancer prevention with doctors. Suitable participants include cancer patients diagnosed between 2018 and 2019 who have tested positive for certain inherited cancer genes, as well as their close relatives who have not undergone genetic testing in the last five years. As an unphased study, this trial offers a unique opportunity for patients to gain valuable insights into their genetic risks and enhance family communication.

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 to focus on genetic counseling and testing, so it's best to discuss your medications with the trial coordinators.

What prior data suggests that this genetic counseling protocol is safe?

Research has shown that the Genetic Information and Family Testing (GIFT) program primarily functions as an online tool. It helps families understand their risk of inherited cancer without introducing new drugs or medical procedures. Instead, the program emphasizes education and communication.

Past studies have shown that similar programs are well-received because they do not involve physical treatments. Since the program focuses on sharing information and offering support, no negative effects have been reported. Prospective participants can feel confident about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for Genetic Counseling for Cancer because it explores the impact of genetic counseling on cancer prevention and management. Unlike traditional cancer treatments that focus on attacking cancer cells, genetic counseling aims to empower individuals with knowledge about their genetic risk factors. This proactive approach can help in early detection and personalized prevention strategies, potentially leading to better outcomes. By understanding an individual’s genetic makeup, healthcare providers can tailor recommendations and interventions, which could revolutionize how we approach cancer care.

What evidence suggests that this trial's treatments could be effective for cancer?

Research has shown that the GIFT study is a promising resource for families facing hereditary cancer risks. Studies have found that the GIFT platform helps families understand their genetic risks and guides them in preventing or detecting cancer early. It provides online education about genetic risks and tools for genetic testing, effectively engaging patients and their families. By increasing awareness and understanding of genetic risks, GIFT aims to empower people to make informed health decisions and prevent cancer. Initial findings suggest that this method can improve how families discuss inherited cancer risks. Overall, GIFT appears to be a valuable resource for families concerned about inherited cancer risks. ^{2 4 6 7 8}

Who Is on the Research Team?

Steven Katz, MD

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

The GIFT Study is for adults diagnosed with any type of cancer in 2018-2019, as recorded by Georgia or California SEER registries. Participants must carry a genetic variation linked to cancer risk and be alive at the time of selection. It's not open to those under 18.

Inclusion Criteria

Patients must be alive at the time of selection as determined through linkage with Georgia and California vital statistics data

I have had genetic testing for cancer risk and the result was positive.

I carry a gene variant linked to cancer risk according to a specific study.

Exclusion Criteria

I am 18 or older, live in the US, Canada, or Mexico, and haven't had doctor-ordered genetic testing in the last 5 years.

I am over 18 and live in the US, Canada, or Mexico.

I have not received genetic testing or do not have a positive genetic test result.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enrollment and Randomization

Eligible patients are enrolled and randomized into one of four study arms

1-2 weeks

Intervention

Participants engage with the GIFT platform, including family communication and genetic testing

6 months

Follow-up

Participants are surveyed to assess communication and genetic testing outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• GIFT

Trial Overview

This study tests the GIFT intervention, which aims to help cancer patients inform their relatives about inherited cancer risks and support them in getting genetic testing and making informed decisions on prevention and early detection.

How Is the Trial Designed?

Group I: Arm 4 Experimental Treatment 1 Intervention

Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.

Group II: Arm 3 Experimental Treatment 1 Intervention

Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.

Group III: Arm 2 Experimental Treatment 1 Intervention

Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.

Group IV: Arm 1 Experimental Treatment 1 Intervention

Arm information details will not be provided at this time in order to preserve scientific integrity and will be updated once the study has resulted.

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

The demand for cancer genetic counseling is increasing, necessitating the exploration of alternative service delivery models like telephone counseling, telegenetics, and group counseling to improve access to care.

While preliminary research suggests these alternative models may be acceptable to patients and improve access, further studies are needed to evaluate their long-term effectiveness and outcomes compared to traditional in-person counseling.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate Service Delivery Models in Cancer Genetic Counseling: A Mini-Review. Buchanan, AH., Rahm, AK., Williams, JL.[2022]

Cancer genetic services are essential for assessing hereditary cancer risks and providing tailored management options, requiring expertise from clinicians trained in both oncology and genetics.

Genetic counselors and nurses play a crucial role in these services, as they are equipped to conduct risk assessments, educate patients, and offer psychosocial support, which can ultimately help reduce cancer-related morbidity and mortality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic counseling and clinical cancer genetics services. Stopfer, JE.[2019]

In a study involving 51 women undergoing breast cancer genetic counseling, it was found that general risks were primarily communicated during initial visits, while specific risks were discussed later, indicating a structured approach to risk communication.

Despite counselors helping counselees understand the information, the way risks were presented (mostly numerically or qualitatively) did not significantly influence counselees' risk perception or satisfaction, suggesting a need for more personalized communication strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk communication in completed series of breast cancer genetic counseling visits. Pieterse, AH., van Dulmen, S., van Dijk, S., et al.[2022]

Genetic counselors in Minnesota reported 37 incidents where patients experienced negative outcomes due to genetics services provided by non-genetics providers, highlighting issues like psychosocial effects and medical mismanagement.

To prevent these negative outcomes, counselors suggested strategies such as educational outreach for healthcare providers, standardized testing processes, and better reporting mechanisms for adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What's the harm? Genetic counselor perceptions of adverse effects of genetics service provision by non-genetics professionals. Bensend, TA., Veach, PM., Niendorf, KB.[2022]

Citations

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The Genetic Information and Family Testing (GIFT) trial.

GIFT demonstrates how an online genetic risk education and genetic testing tool can be delivered to families with hereditary cancer syndromes ...

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The Genetic Information and Family Testing (GIFT) study: trial ...

The goal of the Genetic Information and Family Testing (GIFT) Study is to engage patients about inherited cancer susceptibility and provide support and ...

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Genetic Information and Family Testing Platform to ...

Using the GIFT platform to facilitate genetic testing may help cancer patients' families learn more about their family cancer risk and ways to reduce that risk.

5.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/jgc4.70026

Call to action for genetic counseling research in hereditary ...

Also, very little data were available regarding the effect of genetic counseling on health services-related outcomes such as ordering the ...

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bmccancer.biomedcentral.com/articles/10.1186/s12885-025-13744-6

The Genetic Information and Family Testing (GIFT) study: trial ...

The goal of the Genetic Information and Family Testing (GIFT) Study is to engage patients about inherited cancer susceptibility and provide support and ...

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clinicaltrials.gov

clinicaltrials.gov/study/NCT05552664

The Genetic Information and Family Testing (GIFT) Study

GIFT features a web-based intervention that offers access to an online family communication program containing key facts about genetics, cancer risk, and the ...

8.

cancer.gov

cancer.gov/publications/pdq/information-summaries/genetics/risk-assessment-hp-pdq

Cancer Genetics Risk Assessment and Counseling (PDQ®)

Cancer genetics risk assessment and genetic counseling includes family history, psychosocial assessments, and education on hereditary cancer ...