Enhanced Education for Genetic Testing in Cancer

(GENESIS Trial)

Recruiting at 1 trial location

Overseen By Rachel A Kitchen, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Enloe Health

Disqualifiers: Cognitive impairments, Psychological disorders, Hematologic malignancy, others

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

Compensation: Varies

Number of Visits: 2

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help cancer patients understand the importance of genetic testing. The researchers aim to determine if special education sessions led by oncology nurses can encourage more patients to undergo genetic tests, which can guide their treatment. Participants will receive either these enhanced education sessions or the usual care education typically provided. The trial seeks adults with certain types of solid tumor cancers, such as breast, ovarian, or prostate cancer, who have not undergone genetic testing since 2014. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance cancer care education.

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 focuses on genetic testing and education, so it's best to discuss your specific medications with the trial team.

What prior data suggests that this enhanced education intervention is safe?

In a previous study, researchers found that education and guidance increased the number of people seeking cancer genetic counseling and testing. Another study showed that learning about genetics helped patients understand their cancer better and decide on genetic testing. These educational programs reported no serious safety issues. The focus on teaching and guiding patients is generally safe and well-received.

The improved education method for genetic testing appears safe. It helps patients learn more about their genetics and cancer risk. Similar educational programs have not reported harmful effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Enhanced Education for Genetic Testing in Cancer trial because it aims to improve how patients understand their genetic testing options. Unlike standard education, which typically covers treatment options, side effects, and support services, this enhanced education intervention offers a redesigned session with a trained oncology nurse focusing specifically on genetic testing. This approach could lead to better-informed patients who can make more personalized treatment decisions, potentially improving outcomes and satisfaction with care. By tailoring the education to include genetic insights, researchers hope to empower patients with more control over their cancer treatment journey.

What evidence suggests that this enhanced education intervention is effective for increasing genetic testing uptake in cancer patients?

Research has shown that when oncology nurses lead education sessions, more cancer patients opt for genetic testing. In this trial, participants in the Enhanced Education Intervention arm will attend redesigned therapy education sessions led by a trained oncology nurse. One study found that these targeted educational sessions help patients better understand and accept genetic testing. When nurses provide this education, patients are more likely to complete the testing. This method helps overcome a major hurdle—referring patients for genetic counseling and testing—by utilizing the skills of oncology nurses. By making this information more accessible, patients learn why genetic testing is important for their treatment and family planning. ^{2 3 4 6 7}

Who Is on the Research Team?

Ranjan Pathak, MD MHS

Principal Investigator

Enloe Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 with certain solid tumor cancers (like breast, ovarian, prostate) who could benefit from genetic testing according to guidelines. They should be starting or changing systemic therapy and have not had recent genetic testing.

Inclusion Criteria

I am eligible for gene therapy according to NCCN guidelines.

I meet the criteria for gene therapy as per NCCN guidelines.

I am about to start or change my cancer treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enhanced Education Intervention

Participants receive a redesigned therapy education session with a trained oncology nurse, including detailed education on genetic counseling and testing (GCT) and referral process if eligible.

1 session

1 visit (in-person)

Usual Care Education

Participants receive usual care education provided to cancer patients undergoing systemic therapy, including information on treatment options, side effects, and support services.

1 session

1 visit (in-person)

Follow-up

Participants are monitored for recruitment rates, completion rate of follow-up assessments, and retention rates.

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced education

Trial Overview The study tests if enhanced education by oncology nurses increases the uptake of genetic counseling and testing in cancer patients compared to usual care. It's a pilot randomized study assessing effectiveness and feasibility.

How Is the Trial Designed?

Group I: Enhanced Education Intervention Experimental Treatment 1 Intervention

Patients in the enhanced education intervention arm will be scheduled for a redesigned therapy education session with a trained oncology nurse.

Group II: Usual Care Education Arm Active Control 1 Intervention

Patients in this arm will receive the usual care education provided to cancer patients undergoing systemic therapy, which includes information on treatment options, side effects, and support services without targeted genetic testing education.

Who Is Running the Clinical Trial?

Enloe Health

Lead Sponsor

Trials

1

Recruited

60+

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Robert A. Winn Diversity in Clinical Trials Award Program

Collaborator

Trials

1

Recruited

60+

Enloe Regional Cancer Center

Collaborator

Trials

1

Recruited

60+

Published Research Related to This Trial

A survey of 534 general practitioners (GPs) in Northern Ireland revealed that nearly 75% are interested in attending training courses on genetic testing for cancer, indicating a strong demand for educational programs.

Younger and female GPs showed the highest interest in these courses, suggesting that targeted outreach may be needed for male GPs and those with more experience to enhance their knowledge in genetic testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Genetics and genetic testing: are GPs likely to attend training courses? McCann, S., Macauley, D., Barnett, Y.[2015]

A study of 599 Saudi women revealed that while 54.7% expressed interest in breast cancer genetic testing, there was a significant knowledge deficit about the risks and availability of such testing, with a median knowledge score of only 1.0 out of 7.

Factors positively correlating with interest in genetic testing included being middle-aged, having a higher level of knowledge about breast cancer genetics, and perceiving a higher personal risk for breast cancer, indicating that education could enhance informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Saudi women's interest in breast cancer gene testing: possible influence of awareness, perceived risk and socio-demographic factors. Amin, TT., Al-Wadaani, HA., Al-Quaimi, MM., 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]

A pilot study involving genetic counselors (n=9) and patients (n=24) showed that a workshop on effective communication strategies significantly improved interactions with patients who have limited health literacy, leading to better understanding and satisfaction regarding genetic testing.

Despite some challenges in adopting plain language due to concerns about informed consent, genetic counselors reported positive outcomes in patient comprehension and communication effectiveness after implementing the workshop strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective communication in the era of precision medicine: A pilot intervention with low health literacy patients to improve genetic counseling communication. Joseph, G., Lee, R., Pasick, RJ., et al.[2020]

A systematic review identified 68 educational tools for BRCA1/2 genetic testing from various countries, highlighting a wide diversity in formats and purposes tailored to different phases of genetic testing.

Despite the variety of available tools, many do not adequately cover critical aspects of genetic testing, indicating a need for improvement in educational resources for both patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of educational tools used during the BRCA1/2 genetic testing process. Dorval, M., Bouchard, K., Chiquette, J.[2019]

A pilot study involving 32 oncology healthcare professionals showed that an online training program significantly improved their genetic literacy and communication skills regarding BRCA1/2 testing for breast and ovarian cancer, with 91% reporting new skills and 94% feeling more confident.

The training program was highly accepted, with over 93% of participants finding it clear, informative, and relevant, indicating its potential as a valuable resource for enhancing genetic discussions in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot study of an online training program to increase genetic literacy and communication skills in oncology healthcare professionals discussing BRCA1/2 genetic testing with breast and ovarian cancer patients. Meiser, B., Woodward, P., Gleeson, M., 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]

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]

This trial involves 140 women under 50 years old, newly diagnosed with breast cancer, to compare the effectiveness of an educational pamphlet versus a genetic counseling appointment in informing them about germline BRCA mutation testing.

The study aims to assess various outcomes, including decision-related conflicts and psychosocial impacts over 12 months, to determine the best way to educate patients about genetic testing and its cost-effectiveness in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How should we discuss genetic testing with women newly diagnosed with breast cancer? Design and implementation of a randomized controlled trial of two models of delivering education about treatment-focused genetic testing to younger women newly diagnosed with breast cancer. Watts, KJ., Meiser, B., Mitchell, G., 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]

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]

Complex interventions, including education for patients and healthcare professionals, have been shown to increase access to genetic counseling by an average of 35% and testing completion by 15% in oncology settings, based on a review of 27 studies.

The review highlights the need for more methodologically sound studies to explore the effectiveness of genetic testing integration in oncology, which could lead to improved service delivery models for identifying hereditary cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health system interventions to integrate genetic testing in routine oncology services: A systematic review. O'Shea, R., Taylor, N., Crook, A., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06436157

A Pilot Study of Genetic Testing Uptake Through Enhanced ... The investigators propose a pilot randomized study to evaluate the potential effectiveness, acceptability, and feasibility of a novel, nurse-led "enhanced ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8917095/

A randomized study of genetic education versus usual care ... To address this need, we developed a web‐based genetic education intervention for patients with advanced cancer undergoing tumor genetic ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1098360025002205

Implementing interventions to increase genetic testing for ... To systematically review the implementation strategies, outcomes, and quality of interventions aimed at increasing the uptake of breast cancer-related genetic ...

4. researchprotocols.org researchprotocols.org/2025/1/e72515/PDF

An eHealth Delivery Alternative for Cancer Genetic Testing ... The goal of the eREACH study is to evaluate the effectiveness of replacing traditional pretest (visit 1—education and consent) and posttest ( ...

5. withpower.com withpower.com/trial/phase-solid-tumors-adult-5-2024-caae0

Enhanced Education for Genetic Testing in Cancer Research shows that online training programs can improve healthcare professionals' skills and confidence in discussing genetic testing with cancer patients.

6. cinj.org cinj.org/study-finds-education-and-navigation-increased-cancer-genetic-counseling-andor-testing

Study Finds Education and Navigation Increased Cancer ... Researchers at Rutgers Cancer Institute of New Jersey explored informing patients of their potentially increased risk for generically-inherited cancers.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11981685/

Systematic evidence review and meta-analysis of ... For patient-reported outcomes, pre-test GC significantly decreased worry, increased knowledge, and decreased perceived risk but did not significantly affect ...