A Pilot Study of Genetic Testing Uptake Through Enhanced Oncology Nurse-Led Intervention

NCT06436157 | Recruiting

• 1 other identifier: GENESIS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Solid Tumor, Adult

Keywords

Genetic Counseling and Testing; NCCN guidelines; Utilization; Feasibility; Nurse-led care coordination

Outcome Measures

Primary Outcomes (1)

• Percentage of patients in each arm who proceed to GCT consultation following the intervention.

  Through study completion, an average of 9 months

Secondary Outcomes (3)

• Percentage of patients in each arm referred to GCT

  Through study completion, an average of 9 months

• Average time from GCT referral order to GCT consultation

  Through study completion, an average of 9 months

• Average time from GCT consultation to completion of genetic testing

  Through study completion, an average of 9 months

Other Outcomes (4)

• Recruitment rates, completion rate of follow-up assessments, and retention rates.

  Through study completion, an average of 9 months

• Average scores on the AIM post intervention

  Within 3 weeks of nursing education intervention

• 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

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

Study Arms (2)

Enhanced Education Intervention

EXPERIMENTAL

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

Other: Enhanced education

Usual Care Education Arm

ACTIVE COMPARATOR

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.

Other: Usual care education

Interventions

Enhanced education OTHER

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.

Enhanced Education Intervention

Usual care education OTHER

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.

Usual Care Education Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Davis: lead
• Enloe Regional Cancer Center: collaborator

Study Sites (2)

Enloe Regional Cancer Center

Chico, California, 95926, United States

RECRUITING

University of California, Davis

Sacramento, California, 95616, United States

ACTIVE NOT RECRUITING

Related Publications (11)

• Kurian AW, Abrahamse P, Furgal A, Ward KC, Hamilton AS, Hodan R, Tocco R, Liu L, Berek JS, Hoang L, Yussuf A, Susswein L, Esplin ED, Slavin TP, Gomez SL, Hofer TP, Katz SJ. Germline Genetic Testing After Cancer Diagnosis. JAMA. 2023 Jul 3;330(1):43-51. doi: 10.1001/jama.2023.9526.

  PMID: 37276540 BACKGROUND

• Daly MB, Pal T, Maxwell KN, Churpek J, Kohlmann W, AlHilli Z, Arun B, Buys SS, Cheng H, Domchek SM, Friedman S, Giri V, Goggins M, Hagemann A, Hendrix A, Hutton ML, Karlan BY, Kassem N, Khan S, Khoury K, Kurian AW, Laronga C, Mak JS, Mansour J, McDonnell K, Menendez CS, Merajver SD, Norquist BS, Offit K, Rash D, Reiser G, Senter-Jamieson L, Shannon KM, Visvanathan K, Welborn J, Wick MJ, Wood M, Yurgelun MB, Dwyer MA, Darlow SD. NCCN Guidelines(R) Insights: Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic, Version 2.2024. J Natl Compr Canc Netw. 2023 Oct;21(10):1000-1010. doi: 10.6004/jnccn.2023.0051.

  PMID: 37856201 BACKGROUND

• Kurian AW, Ward KC, Abrahamse P, Bondarenko I, Hamilton AS, Deapen D, Morrow M, Berek JS, Hofer TP, Katz SJ. Time Trends in Receipt of Germline Genetic Testing and Results for Women Diagnosed With Breast Cancer or Ovarian Cancer, 2012-2019. J Clin Oncol. 2021 May 20;39(15):1631-1640. doi: 10.1200/JCO.20.02785. Epub 2021 Feb 9.

  PMID: 33560870 BACKGROUND

• Swink A, Nair A, Hoof P, Matthews A, Burden C, Johnson K, Blum JL. Barriers to the utilization of genetic testing and genetic counseling in patients with suspected hereditary breast and ovarian cancers. Proc (Bayl Univ Med Cent). 2019 Jun 11;32(3):340-344. doi: 10.1080/08998280.2019.1612702. eCollection 2019 Jul.

  PMID: 31384183 BACKGROUND

• McAllister KA, Schmitt ML. Impact of a nurse navigator on genomic testing and timely treatment decision making in patients with breast cancer. Clin J Oncol Nurs. 2015 Oct;19(5):510-2. doi: 10.1188/15.CJON.510-512.

  PMID: 26414569 BACKGROUND

• Rives TA, Pavlik H, Li N, Qasrawi L, Yan D, Pickarski J, Dietrich CS, Miller RW, Ueland FR, Kolesar JM. Implementation of Nurse Navigation Improves Rate of Molecular Tumor Testing for Ovarian Cancer in a Gynecologic Oncology Practice. Cancers (Basel). 2023 Jun 15;15(12):3192. doi: 10.3390/cancers15123192.

  PMID: 37370804 BACKGROUND

• DiBiase JF, Scharnetzki E, Edelman E, Lucas FL, Helbig P, Rueter J, Han PKJ, Ziller E, Jacobs EA, Anderson EC; MCGI Working Group. Urban-Rural and Socioeconomic Differences in Patient Knowledge and Perceptions of Genomic Tumor Testing. JCO Precis Oncol. 2023 Mar;7:e2200631. doi: 10.1200/PO.22.00631.

  PMID: 36893376 BACKGROUND

• Anderson EC, Hinton AC, Lary CW, Fenton ATHR, Antov A, Edelman E, Helbig P, Reed K, Miesfeldt S, Thomas CA, Hall MJ, Roberts JS, Rueter J, Han PKJ; MCGI Working Group. Community oncologists' perceptions and utilization of large-panel genomic tumor testing. BMC Cancer. 2021 Nov 25;21(1):1273. doi: 10.1186/s12885-021-08985-0.

  PMID: 34823486 BACKGROUND

• Idos GE, Kurian AW, Ricker C, Sturgeon D, Culver JO, Kingham KE, Koff R, Chun NM, Rowe-Teeter C, Lebensohn AP, Levonian P, Lowstuter K, Partynski K, Hong C, Mills MA, Petrovchich I, Ma CS, Hartman AR, Allen B, Wenstrup RJ, Lancaster JM, Brown K, Kidd J, Evans B, Mukherjee B, McDonnell KJ, Ladabaum U, Ford JM, Gruber SB. Multicenter Prospective Cohort Study of the Diagnostic Yield and Patient Experience of Multiplex Gene Panel Testing For Hereditary Cancer Risk. JCO Precis Oncol. 2019 Mar 28;3:PO.18.00217. doi: 10.1200/PO.18.00217. eCollection 2019 Mar.

  PMID: 34322651 BACKGROUND

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MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ranjan Pathak, MD MHS

  Enloe Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel A Kitchen, CCRP

CONTACT

406-417-1576; rkitchen@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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".

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 30, 2024
• Study Start: December 26, 2024
• Primary Completion: March 26, 2025
• Study Completion: September 26, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)