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A population-based virtual solution to reduce gaps in genetic risk evaluation and management in families at high risk for hereditary cancer syndromes: The Georgia-California GeneLINK Trial

Award Number: U01CA254822
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Project Abstract: There is growing evidence that targeting genetic risk evaluation (GRE) in families where a cancer susceptibility gene pathogenic variant (PV) has been identified may be the most cost-effective approach to reduce the population burden of cancer through prevention. However, there are enormous challenges to implementing successful cascade genetic risk evaluation in families with hereditary cancer syndromes. The clinical context of GRE after cancer diagnosis is increasingly complex: As MGP testing has become the norm, guideline organizations have converged on a list of >40 cancer susceptibility genes in which PVs are clinically actionable, with wide variability in cancer threat and a myriad of strategies for prevention and early detection. A daunting challenge is that the cancer patient is responsible for communication and engagement of relatives for GRE. Despite the shared health threat among at risk relatives (ARRs), the social and contextual factors that affect family communication are complex. Furthermore, ARRs are dispersed world- wide and receive care in disparate health care practices. Importantly, there is little incentive and limited resources for clinicians to engage cancer patients’ relatives and genetic counseling services are increasingly strained. Given the lack of guidance for families, it is not surprising that most ARRs of cancer patients with PVs do not undergo GRE. We are uniquely positioned to develop and optimize a direct-to-family virtual genetic risk evaluation and testing solution offered to all at risk relatives of a population-based sample of adults recently diagnosed with cancer in Georgia and California who tested positive for a clinically relevant PV. We will use a unique data infrastructure we pioneered to identify and invite a diverse cohort of cancer patients with clinically relevant PVs and their families to participate in our study. We propose a 2 x 3 factorial randomized trial of 900 patients diagnosed in 2018-2019 in the two states who had a clinically significant PV detected by genetic testing that will offer genetic risk evaluation and testing to all 1st and 2nd degree relatives. We will evaluate the effects of two intervention design features on patient- and relative-centered outcomes: 1) the level of personalized family genetic risk support (a technology assisted personally tailored patient and family member education and communication tool called the Family Genetic Health Program, FGHP) vs. the FGHP plus direct assistance from a human FGHP Navigator); and 2) the price offered to the relatives for the genetic test (standard $200 vs. $100 vs. $50 per test). We will determine the independent effects of the two design features on 1) the cancer patient’s appraisal of communication and their engagement with relatives about hereditary cancer and GRE; 2) the invited relative’s appraisal of decision-making and receipt of genetic testing; and 3) on the enrolled relative’s completion of formal GRE. We will also explore the effect of the features on the outcomes across patient SES subgroups. The findings of this study have enormous potential to improve cancer prevention and early detection in families at high risk of hereditary cancer syndromes in the US.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $631,997 )
2024	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	002	5	9/9/2024	NON-COMPETING CONTINUATION	$194,431
2024	2024	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	5	8/7/2024	NON-COMPETING CONTINUATION	$437,566
2024	2023	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	4	11/14/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $631,997

Issue Date FY: 2023 ( Subtotal = $742,946 )
2023	2023	REGENTS OF THE UNIVERSITY OF MICHIGAN	1109 GEDDES AVE, SUITE 3300	ANN ARBOR	MI	48109	WASHTENAW	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	4	9/8/2023	NON-COMPETING CONTINUATION	$742,946
2023	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON STREET	ANN ARBOR	MI	48109	WASHTENAW	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	3	1/30/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $742,946

Issue Date FY: 2022 ( Subtotal = $750,931 )
2022	2022	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	3	9/9/2022	NON-COMPETING CONTINUATION	$750,931
														Subtotal = $750,931

Issue Date FY: 2021 ( Subtotal = $752,888 )
2021	2021	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	2	8/13/2021	NON-COMPETING CONTINUATION	$752,888
2021	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	2/11/2021	NEW	$0
														Subtotal = $752,888

Issue Date FY: 2020 ( Subtotal = $796,445 )
2020	2020	REGENTS OF THE UNIVERSITY OF MICHIGAN	503 THOMPSON ST	ANN ARBOR	MI	48109	WASHTENAW	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	9/15/2020	NEW	$796,445
														Subtotal = $796,445

Grand Total All Awards = $3,675,207

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A population-based virtual solution to reduce gaps in genetic risk evaluation and management in families at high risk for hereditary cancer syndromes: The Georgia-California GeneLINK Trial

Award Number: U01CA254822

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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