## Protocol Section
### Identification Module
**NCT ID:** NCT06436157

**Acronym:** GENESIS

**Brief Title:** A Pilot Study of Genetic Testing Uptake Through Enhanced Oncology Nurse-Led Intervention

**Official Title:** Genetic Testing Uptake Through an Enhanced Oncology Nurse-Led Intervention in Patients With Solid Tumors (GENESIS): A Pilot Study

#### Organization Study ID Info
**ID:** Study #116
#### Organization
**Class:** OTHER
**Full Name:** Enloe Health
### Status Module
#### Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-28

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-28
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Robert A. Winn Diversity in Clinical Trials Award Program

#### Lead Sponsor

**Class:** OTHER

**Name:** Enloe Health

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

**Detailed Description:** Identification of germline risk can have important implications for both patients and their families: it can help patients develop tailored cancer surveillance, risk-reducing measures, reproductive planning, identify novel genotype-directed drug targets, and also optimally address the risk of malignancy in at-risk relatives. Although estimates vary, pathogenic germline variants (PGV) can be seen in \~3-17.5% of unselected patients with cancer with important clinical significance. Although national and international guidelines such as the National Comprehensive Cancer Network (NCCN) outline the criteria for who should be offered genetic counseling and testing (GCT) based on a patient's personal and/or family history, recent studies have found that broader testing of at-risk patients might help identify PGV in patients who otherwise would not have met guidelines for genetic testing.

Unfortunately, despite progress in multigene testing and the identification of heritable conditions, GCT remains underutilized among cancer patients. A recent study revealed that the uptake of germline testing among cancer patients remains strikingly low; in California and Georgia, between 2013 and 2019, less than 7% of patients diagnosed with cancer underwent such testing. While a study indicates a promising recent increase in the use of germline testing among women diagnosed with breast and ovarian cancer from 2012 to 2019, there is still a significant gap in ensuring that all eligible patients are provided with GCT. 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.

Community cancer centers are crucial in providing accessible care to a large segment of the cancer patient population. However, community cancer centers often face various challenges with limited resources for specialized genetic services variability in community oncologists' practice patterns and perceptions in GCT, and potentially urban-rural variability in patient awareness and understanding of the potential impact of genetic testing on their care.

Nurse navigation has been shown to improve the timeliness of cancer care and patient outcomes across various cancer types, in addition to improving 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. This approach leverages the trust and communication between nurses and patients and the principle that informed patients are more likely to engage in their healthcare decisions to potentially overcome barriers to genetic testing uptake.

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. Patients in the enhanced education arm will be scheduled for an enhanced therapy education session with a trained oncology nurse for patients starting or switching their systemic therapies. In addition to the education conducted as part of the usual care, the nurse will: 1) provide detailed education on GCT; and 2) if the patient is eligible and agreeable to GCT, order a referral to GCT (if not already ordered). Nurses will provide a "nudge" to the referral coordinators within a week of the education session to ensure the referral process is completed.

### Conditions Module

**Conditions:**

- Solid Tumor, Adult

**Keywords:**

- Genetic Counseling and Testing

- NCCN guidelines

- Utilization

- Feasibility

- Nurse-led care coordination

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** This pilot study will randomize patients who are starting or switching their systemic therapies for solid cancers, eligible for GCT, and have not undergone prior genetic testing into two groups: "enhanced education intervention" and "usual care education".

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Other: Enhanced education

**Label:** Enhanced Education Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Other: Usual care education

**Label:** Usual Care Education Arm

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Enhanced Education Intervention

**Description:** In addition to the education conducted as part of usual care, the nurse will: 1) provide basic education on GCT; and 2) if the patient is eligible and agreeable to GCT, place a referral to GCT (if not already ordered).

Patients will also be provided with written materials reinforcing the key messages of GCT education, designed to be understandable to individuals without a medical background. Nurses will also conduct a follow-up "nudge" by sending an in basket message via electronic medical record to ensure that the referrals are processed by the referral coordinators.

**Name:** Enhanced education

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Usual Care Education Arm

**Description:** A brief introduction to GCT will be provided in accordance with the information covered in the "chemo education binder," which is the current standard of care at Enloe Regional Cancer Center. As per the usual care, referrals for genetic testing will be clinician-initiated without the proactive involvement of the RN.

**Name:** Usual care education

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** Recruitment rates (percentage of participants who agree to participate out of those approached), completion rate of follow-up assessments (percentage of patients that complete follow-up assessment), and retention rates (percentage of patients retained in the study throughout the study period).

**Measure:** Recruitment rates, completion rate of follow-up assessments, and retention rates.

**Time Frame:** Through study completion, an average of 9 months

**Measure:** Average scores on the AIM post intervention

**Time Frame:** Within 3 weeks of nursing education intervention

**Measure:** Average scores and qualitative feedback from post-intervention survey questionnaire to measure satisfaction with the study and recommendations for improvement from participants, nurses and genetic counselors

**Time Frame:** Within 3 weeks of nursing education intervention and through study completion, an average of 9 months

**Measure:** RN workload as measured by average time spent per patient and perception (Likert-scale-based and qualitative feedback)

**Time Frame:** Through study completion, an average of 9 months

#### Primary Outcomes

**Measure:** Percentage of patients in each arm who proceed to GCT consultation following the intervention.

**Time Frame:** Through study completion, an average of 9 months

#### Secondary Outcomes

**Measure:** Percentage of patients in each arm referred to GCT

**Time Frame:** Through study completion, an average of 9 months

**Measure:** Average time from GCT referral order to GCT consultation

**Time Frame:** Through study completion, an average of 9 months

**Measure:** Average time from GCT consultation to completion of genetic testing

**Time Frame:** Through study completion, an average of 9 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Adults (≥ 18 years)
* Diagnosed with a solid tumor cancer type that has established guidelines suggesting the utility of genetic testing in treatment (breast, ovarian, prostate, pancreatic, colon, Lynch syndrome-related cancers (colorectal, endometrial, gastric, ovarian, pancreatic, urothelial, brain (usually glioblastoma), biliary tract, small intestine), Li-Fraumeni syndrome tumor spectrum (e.g., soft tissue sarcoma, osteosarcoma, central nervous system tumors, breast cancer, adrenocortical carcinoma), etc.)
* Eligible for GCT based on the current NCCN guidelines
* Starting new systemic therapy or switching systemic therapy
* Eligible for GCT as per the current NCCN guidelines
* No prior genetic testing (or tested before 2014)

Exclusion Criteria:

* Prior GCT with test results available (if tested 2014 onwards)
* Patients scheduled for treatment education with Advanced Practice Provider (typically reserved for more complex regimens)
* Patients with cognitive impairments or severe psychological disorders that would limit their ability to understand the genetic counseling/testing information or give informed consent.
* Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures (e.g., patients requiring urgent therapy and/or inpatient chemotherapy initiation).
* Patients who are currently participating in other clinical trials that could confound the outcomes of genetic testing uptake.
* Prospective participants who, in the investigator's opinion, may not be able to comply with all study procedures (including compliance issues related to logistics).
* Hematologic malignancy

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** tiffany.capuano@enloe.org

**Name:** Tiffany Capuano, RN, BSN, OCN

**Phone:** 530-332-3858

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Enloe Health

**Name:** Ranjan Pathak, MD MHS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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**PMID:** 37856201

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## Derived Section

### Misc Info Module

- Version Holder: 2024-05-31
