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

1000 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 focused on genetic education and testing, so it's unlikely that your medications will be affected.

What data supports the effectiveness of the treatment Color Genomics genetic education, Doxy.me genetic education +/- Color Genomics genetic education?

Research shows that using educational tools tailored to patients' understanding, like videos and simplified content, can significantly improve their knowledge and attitudes towards genetic testing. This suggests that genetic education treatments, such as those provided by Color Genomics and Doxy.me, may help patients better understand and engage with their cancer care. ^{1 2 3 4 5}

Is genetic education for cancer testing safe for humans?

The research articles provided do not contain specific safety data for genetic education treatments like Color Genomics or Doxy.me. They focus on improving understanding and usability of genetic test results, but do not address safety concerns. ^{6 7 8 9 10}

How does the treatment in the Genetic Education for Cancer Testing trial differ from other treatments for cancer?

This treatment is unique because it focuses on educating patients about the genetic aspects of cancer, helping them understand how genetics can influence their condition and treatment options. Unlike traditional treatments that directly target cancer cells, this approach aims to empower patients with knowledge to make informed decisions about their care. ^{8 11 12 13 14}

What is the purpose of this trial?

The goal of the GENERATE Study is to improve genetic testing and cancer prevention in family members of pancreatic cancer patients who may have genetic mutations (inherited changes). The study will measure how different methods of genetic education increase the rate of genetic testing in these families. This is an investigational study to measure the effects of two methods of genetic education. Participants may elect to undergo genetic testing as part of the study and will be asked to provide a saliva sample via a saliva-testing kit. The genetic testing done in this study is FDA approved and will be processed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory. Up to 1,000 participants will be enrolled in this study.

Research Team

Sapna Syngal, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

References

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

Engaging Patients in Precision Oncology: Development and Usability of a Web-Based Patient-Facing Genomic Sequencing Report. [2021]

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

Guiding Oncology Patients Through the Maze of Precision Medicine. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Web Screening on Training Initiatives in Cancer Genomics for Healthcare Professionals. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Genetic and genomic learning needs of oncologists and oncology nurses in the era of precision medicine: a scoping review. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The Impact of an Educational Video in Arabic Language on Patients' Knowledge and Attitudes Towards Genetic Testing for Cancer Therapy. [2023]

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

Evaluating co-created patient-facing materials to increase understanding of genetic test results. [2022]

7. England pubmed.ncbi.nlm.nih.gov

An assessment of patient perspectives on pharmacogenomics educational materials. [2022]

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

Web applications aid clinical trial recruitment. [2012]

9. Canada pubmed.ncbi.nlm.nih.gov

Exploring Genetic Data Across Individuals: Design and Evaluation of a Novel Comparative Report Tool. [2023]

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

Getting to the point: what women newly diagnosed with breast cancer want to know about treatment-focused genetic testing. [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

Human genetics education as part of the Japanese Cancer Education Comprehensive Support Project. [2023]

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

Genomic oncology education: an urgent need, a new approach. [2021]

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

Getting a head start: the importance of personal genetics education in high schools. [2021]

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

Evidence that personal genome testing enhances student learning in a course on genomics and personalized medicine. [2021]