Genetic Counseling for Cancer

(GIFT Trial)

Recruiting 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

2464 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. It seems to focus on genetic counseling and testing, so it's best to discuss your medications with the trial coordinators.

What data supports the effectiveness of the treatment GIFT in genetic counseling for cancer?

The research highlights the importance of effective communication and understanding patient needs in genetic counseling, which can improve patient satisfaction and outcomes. While it doesn't directly address the GIFT treatment, focusing on patient preferences and sensitive communication has been shown to enhance the counseling process, which may indirectly support the effectiveness of treatments like GIFT. ^{1 2 3 4 5}

Is genetic counseling for cancer safe for humans?

Genetic counseling for cancer is generally considered safe, but there can be negative outcomes if services are provided by non-genetics professionals, such as emotional distress or errors in testing. It's important to receive counseling from qualified genetics professionals to minimize these risks. ^{6 7 8 9 10}

How is genetic counseling for cancer different from other treatments for cancer?

Genetic counseling for cancer is unique because it focuses on assessing cancer risk based on family history and genetics, rather than directly treating cancer itself. It involves education, risk management, and psychosocial support, helping individuals understand their hereditary cancer risk and make informed decisions about genetic testing and prevention strategies. ^{7 11 12 13 14}

What is the purpose of this trial?

The Genetic Information and Family Testing (GIFT) Study is designed to support the capacity, opportunity, and motivation of cancer patients to engage their relatives about inherited cancer susceptibility and provide support and services to those relatives to initiate GRE (including genetic testing) and prepare them to subsequently engage their clinicians in informed decision-making about cancer prevention and early detection.

Research Team

Steven Katz, MD

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Alternate Service Delivery Models in Cancer Genetic Counseling: A Mini-Review. [2022]

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

Differences in individual approaches: communication in the familial breast cancer consultation and the effect on patient outcomes. [2018]

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

Focusing on patient needs and preferences may improve genetic counseling for colorectal cancer. [2021]

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

Analyzing the process and content of genetic counseling in familial breast cancer consultations. [2018]

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

Most patients with colorectal tumors at young age do not visit a cancer genetics clinic. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Design of the BRISC study: a multicentre controlled clinical trial to optimize the communication of breast cancer risks in genetic counselling. [2019]

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

Essential elements of genetic cancer risk assessment, counseling, and testing: updated recommendations of the National Society of Genetic Counselors. [2022]

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

Genetic cancer risk assessment and counseling: recommendations of the national society of genetic counselors. [2022]

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

Risk communication in completed series of breast cancer genetic counseling visits. [2022]

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

What's the harm? Genetic counselor perceptions of adverse effects of genetics service provision by non-genetics professionals. [2022]

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

Genetic counseling and clinical cancer genetics services. [2019]

12. Denmark pubmed.ncbi.nlm.nih.gov

To tell or not to tell: barriers and facilitators in family communication about genetic risk. [2019]

13. England pubmed.ncbi.nlm.nih.gov

Dealing with the uncertainty of developing a cancer. [2019]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Prevalence and detection of psychosocial problems in cancer genetic counseling. [2018]