Genetic Education for Cancer Testing

(GENERATE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Cancer susceptibility gene, Genetic counseling, Hematologic malignancy, 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 evaluate how different educational methods about genetics can increase genetic testing among families of pancreatic cancer patients. Researchers are testing two methods: one involves an online platform with videos and a live session with a counselor (Color Genomics genetic education), and the other uses a website with educational content (Doxy.me genetic education +/- Color Genomics genetic education). Participants may choose to undergo genetic testing by providing a saliva sample. Eligible participants have a close family member with pancreatic cancer and a known genetic mutation in the family. As an unphased trial, this study offers participants the chance to contribute to innovative educational approaches that could improve access to and understanding of genetic 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 seems focused on genetic education and testing, so it's unlikely that your medications will be affected.

What prior data suggests that these methods of genetic education are safe?

Previous research has shown that both methods of genetic education used in this study—Color Genomics and Doxy.me—are safe for people.

Color Genomics provides genetic testing and education approved by the FDA, meeting strict safety standards. The genetic tests occur in labs that adhere to all necessary regulations to ensure accuracy and safety.

Doxy.me serves as the platform for genetic education sessions. It complies with important privacy laws to protect personal information and is widely used by healthcare providers for secure online visits, ensuring careful handling of data and privacy.

Overall, both genetic education methods in this study are designed to be safe and comfortable for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to educate people about genetic testing for cancer. Unlike traditional methods that might involve in-person consultations, this trial leverages online platforms like Color Genomics and Doxy.me to provide genetic education. The unique aspect is the combination of interactive video conferencing with a genetic counselor and self-paced learning through online content. This approach could make genetic education more accessible and engaging, potentially empowering more individuals to make informed decisions about genetic testing.

What evidence suggests that this trial's genetic education methods could be effective for increasing genetic testing in families of pancreatic cancer patients?

Studies have shown that learning about genetics can significantly increase the number of people who undergo testing for hereditary cancers. In this trial, participants in the Color Genomics Only Arm will access genetic education on the Color Genomics website, which uses detailed gene analysis and has identified genetic changes linked to cancer for over 23,000 people. Research indicates that this type of genetic testing can reveal important risk factors, enabling early cancer prevention. Participants in the Doxy.me plus Color Genomics Arm will receive genetic education through the Doxy.me platform, which offers educational videos and live counseling to enhance understanding and engagement with genetic information. Both methods in this trial aim to equip people with the knowledge needed to make informed health decisions. ^{4 6 7 8 9}

Who Is on the Research Team?

Sapna Syngal, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

The GENERATE Study is for adults with a close relative who had pancreatic cancer and may carry certain genetic mutations. Participants must be willing to provide saliva samples, complete questionnaires, share results with their healthcare provider, and have not received recent genetic counseling or blood transfusions.

Inclusion Criteria

Individual who has signed the informed consent

Individual with a valid United States mailing address

I can see a doctor and am willing to share my genetic test results.

Exclusion Criteria

I am unable to sign the consent form due to a mental health condition.

I have a gene that increases my risk for cancer.

I have had genetic counseling for cancer risk in the past 3 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Genetic Education and Testing

Participants receive genetic education through either Doxy.me or Color Genomics and may elect to undergo genetic testing

4-6 weeks

Online sessions and interactions

Follow-up

Participants are monitored for family communication about genetic test results and uptake of surveillance for pancreatic and other associated cancers

15 months

Long-term Follow-up

Participants may be contacted regarding participation in future studies

18 months total participation

What Are the Treatments Tested in This Trial?

Interventions

• Color Genomics genetic education
• Doxy.me genetic education +/- Color Genomics genetic education

Trial Overview This study tests two methods of genetic education to see if they increase the rate of genetic testing in families at risk for inherited pancreatic cancer. It involves FDA-approved testing processed in a certified lab and aims to enroll up to 1,000 participants.

How Is the Trial Designed?

Group I: Doxy.me plus Color Genomics Arm (Arm 1) Experimental Treatment 1 Intervention

* Participants in this arm will receive genetic education through an online platform called Doxy.me * The Doxy.me session will consist of two parts: 1) a pre-recorded genetic education video 2) a live interactive video conferencing session with a GENERATE genetic counselor * After completing the Doxy.me session and post intervention questionnaires, participants will be directed to the Color Genomics study portal where they may elect to review Color Genomics' genetic education content or proceed directly to order genetic testing * Intervention is Doxy.me genetic education +/- genetic education via Color Genomics website

Group II: Color Genomics Only Arm (Arm 2) Experimental Treatment 1 Intervention

* Participants in this arm will access genetic education on the Color Genomics website which includes both written information and an educational video * After accessing the Color Genomics website, participants may elect to review educational content or proceed directly to order genetic testing * Intervention is genetic education via Color Genomics website

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Stand Up To Cancer

Collaborator

Trials

53

Recruited

40,100+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Lustgarten Foundation

Collaborator

Trials

27

Recruited

5,500+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

A study involving 26 young women with breast cancer revealed that most preferred to receive information about treatment-focused genetic testing (TFGT) at the time of their diagnosis through face-to-face consultations.

The pilot-tested educational pamphlet on TFGT was well-received, indicating its potential effectiveness in helping women make informed decisions about genetic testing during a challenging time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Getting to the point: what women newly diagnosed with breast cancer want to know about treatment-focused genetic testing. Meiser, B., Gleeson, M., Watts, K., et al.[2019]

Co-creating patient-facing materials for genetic test results, specifically for congenital hypogonadotropic hypogonadism, resulted in high-quality resources that were rated as understandable and actionable by patients and parents, with an average reading level suitable for 8th-9th graders.

The study found that while most aspects of the materials scored highly in understandability (90%-97%), visual aids received the lowest rating (89%), indicating a need for improvement in this area to enhance overall comprehension, especially for patients with varying levels of health literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating co-created patient-facing materials to increase understanding of genetic test results. Dwyer, AA., Au, MG., Smith, N., et al.[2022]

A study involving 90 patients and caregivers showed that translating complex genetic information about melanoma to a 6th-grade reading level significantly improved understanding, especially when using multiple learning modalities.

Patients who received information with embedded videos explaining key genetic concepts (Group C) demonstrated the greatest increase in knowledge, highlighting the importance of tailored educational approaches in enhancing patient engagement in precision medicine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guiding Oncology Patients Through the Maze of Precision Medicine. Giuse, NB., Kusnoor, SV., Koonce, TY., et al.[2023]

Oncologists and oncology nurses require specific training and education to effectively interpret genomic data and integrate it into clinical decision-making for cancer care, as identified in a scoping review.

There is a notable gap in empirical research focusing on the learning needs of oncology nurses regarding tumor sequencing, highlighting the need for tailored support in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetic and genomic learning needs of oncologists and oncology nurses in the era of precision medicine: a scoping review. Rahman, B., McEwen, A., Phillips, JL., et al.[2022]

The HOPE-Genomics tool, designed to enhance patient understanding of genomic sequencing results, received positive feedback from patients, family members, and healthcare providers, indicating a strong interest in its use for improving communication about genomic information.

Participants expressed a desire for a user-friendly report that includes various types of genomic data and access to genetic counseling, highlighting the potential of the tool to empower patients in their cancer care journey.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engaging Patients in Precision Oncology: Development and Usability of a Web-Based Patient-Facing Genomic Sequencing Report. Solomon, IB., McGraw, S., Shen, J., et al.[2021]

Citations

1. color.com color.com/individuals-genomics

Genetic Testing Accessible, clinical-grade genetic testing. Unlike recreational genetic tests, we focus on thorough sequencing of genes to give you meaningful insights.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03762590?tab=history&a=6

Record History | ver. 6: 2019-05-01 | NCT03762590 Individuals in Arm 1 (video conference platform plus Color Genomics) will receive genetic education via a pre-recorded educational video and interactive session ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11034726/

The Genetic Education, Risk Assessment, and Testing ... A randomized trial of two remote healthcare delivery models on the uptake of genetic testing and impact on patient-reported psychological outcomes in families ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1525157818303349

Multi-Gene Panel Testing of 23179 Individuals for ... The Color Hereditary Cancer Test was used to analyze 30 genes in which pathogenic variants have been associated with an elevated risk of hereditary cancer ...

5. frontiersin.org frontiersin.org/journals/genetics/articles/10.3389/fgene.2024.1374602/full

Test-takers' perspectives on consumer genetic testing for ... This study offers new insights into how individuals use and perceive modern consumer genetic tests for hereditary cancer risk.

6. theregreview.org theregreview.org/2021/01/23/saturday-seminar-privacy-problems-genetic-testing/

Privacy Problems in the Genetic Testing Industry Companies such as 23andMe, Color Genomics, and AncestryDNA sell genetic tests that determine the test taker's ancestry, screen for certain ...

7. karger.com karger.com/article/doi/10.1159/000546189

Workplace Genomic Testing: What Do Company Websites ... Employees considering participation in wGT as part of workplace wellness programs should be aware of legal protection of their personal genetic ...

8. via.library.depaul.edu via.library.depaul.edu/cgi/viewcontent.cgi?article=4086&context=law-review

Direct-to-Consumer Genetic Testing: The FDA's Dual Role ... Color Genomics, ostensibly a competitor of 23andMe, offers several genetic tests for which 23andMe lacks FDA approval. For example, Color ...

9. color.com color.com/informed-consent

Informed Consent Clinical results and genetic testing information are HIPAA protected and confidential, and will only be shared further with your permission and in accordance ...