Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436157
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-15
Brief Title:
A Pilot Study of Genetic Testing Uptake Through Enhanced Oncology Nurse-Led Intervention
Sponsor:
Enloe Health
Organization:
Enloe Health
Study Overview
Official Title:
Genetic Testing Uptake Through an Enhanced Oncology Nurse-Led Intervention in Patients With Solid Tumors GENESIS A Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GENESIS
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 3-175 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
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 3-175 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 patients personal andor 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None