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

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

What data supports the effectiveness of the treatment 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. This suggests that enhanced education can help patients better understand their genetic testing results, potentially leading to improved patient outcomes. ^{1 2 3 4 5}

Is the Enhanced Education for Genetic Testing in Cancer safe for humans?

The studies reviewed focus on educational programs to improve understanding and communication about genetic testing, primarily for healthcare professionals and patients. These programs are generally considered safe as they involve training and information sharing, not medical treatments or interventions. ^{1 2 6 7 8}

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

The 'Enhanced Education for Genetic Testing in Cancer' treatment is unique because it focuses on improving patients' understanding of genetic testing, which can help them make informed decisions about their cancer treatment. Unlike traditional treatments that directly target cancer cells, this approach aims to fill knowledge gaps and enhance decision-making by providing comprehensive educational strategies tailored to individual needs. ^{1 9 10 11 12}

What is the purpose of this trial?

Genetic factors are a significant determinant of the likelihood of developing various types of cancers. Identification of germline risk can have important implications for both patients and their families. Although estimates vary, pathogenic germline variants can be seen in \~3-17.5% of unselected patients with cancer with important clinical significance. Unfortunately, despite progress in multigene testing and the identification of heritable conditions, genetic counseling and testing (GCT) remains underutilized among cancer patients. Although there are multiple barriers to low testing, initial referral to GCT from the treating oncologist has been noted to be the most significant barrier. Nurse navigation has been shown to improve the timeliness of cancer care and patient outcomes across various cancer types and improve the uptake of genomic testing in cancer patients. Despite proven benefits, community cancer centers often face resource limitations that prevent them from consistently assigning a dedicated nurse navigator to cancer patients. However, community centers universally have oncology nurses who routinely educate patients about their systemic therapies. By enhancing the "therapy education" sessions, the investigators hypothesize that oncology nurses can bridge this gap and potentially identify eligible patients, provide essential education on the importance of genetic testing, and facilitate the referral process. The investigators propose a pilot randomized study to evaluate the potential effectiveness, acceptability, and feasibility of a novel, nurse-led "enhanced education" intervention specifically designed to increase the uptake of GCT in adult cancer patients.

Research Team

Ranjan Pathak, MD MHS

Principal Investigator

Enloe Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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 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]

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 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]

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]

References

1. Netherlands 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. [2022]

2. 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]

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

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

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

Health system interventions to integrate genetic testing in routine oncology services: A systematic review. [2021]

6. 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]

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

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

8. Netherlands 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. [2020]

9. Thailand pubmed.ncbi.nlm.nih.gov

Saudi women's interest in breast cancer gene testing: possible influence of awareness, perceived risk and socio-demographic factors. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Systematic review of educational tools used during the BRCA1/2 genetic testing process. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Genetics and genetic testing: are GPs likely to attend training courses? [2015]

12. England 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. [2021]