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A Randomized Hybrid Type I effectiveness-implementation study of an Ehealth delivery Alternative for Cancer genetic testing for Hereditary cancer predisposition (eREACH)

Award Number: U01CA243702
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/17/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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A Randomized Hybrid Type I effectiveness-implementation study of an Ehealth delivery Alternative for Cancer genetic testing for Hereditary cancer predisposition (eREACH) - Germline cancer genetic testing has become a standard evidence-based practice, with established risk reduction and cancer screening guidelines for genetic carriers. Yet, access to genetic specialists is limited in many areas in the US, and <20% of eligible patients with a personal or family history of breast or ovarian cancer complete genetic testing. Thus, there is an urgent need to consider alternative delivery models to increase access and uptake of genetic testing, while maintaining adequate patient cognitive, affective and behavioral outcomes. Our research has shown that providing remote services increases uptake of genetic testing in community practices increases uptake of genetic testing. Preliminary data from our ongoing NIH-funded RESPECT study has revealed high interest in a web-based eHealth alternative to traditional pre-test counseling and no significant no differences in pre- and post-disclosure outcomes when the web-based eHealth intervention is utilized as compared to participants who received traditional pre-test genetic counselor. To address the clinically significant need for alternative delivery models to increase access and uptake of cancer genetic testing, while maintaining adequate patient cognitive, affective and behavioral outcomes, we propose to recruit a nationally diverse “real- world” sample of 1000 patients who have access barriers to genetic testing and to conduct a Hybrid Type 1 effectiveness-implementation study to evaluate web-based eHealth delivery alternatives for genetic education and testing. We hypothesize that our theoretically and stakeholder informed eHealth delivery alternatives can provide equal or better uptake of testing and outcomes of genetic testing as compared to the traditional model of pre- and post-test counseling with a genetic counselor. We will partner with several cancer advocacy groups (ASCO, breastcancer.org, Cancer Support Community, Pennsylvania Prostate Cancer Coalition) to recruit patients to this randomized non-inferiority study using a modified 2x2 design (Aims 1-2). In Arm 1, traditional pre-test (visit 1) and post-test (visit 2: disclosure) counseling will be provided remotely through the national Penn Telegenetics Program and compared to delivery arms where patients can complete pre-test and/or disclosure of results through a self-directed web-based eHealth intervention, either in place of, or as an adjunct to traditional genetic counseling. Concurrently, we will conduct a CFIR (Consolidated Framework for Implementation Research)-informed process evaluation to understand moderators of intervention usage and patient outcomes and facilitators and barriers to future implementation and sustainability of this novel eHealth alternative delivery model for genetic services both within and beyond cancer care (Aim 3). We hypothesize that a rigorously developed theoretically and stake-holder informed eHealth delivery alternative provided through a centralized Telegenetics Program has the potential to provide equal or improved patient outcomes, while reducing genetic provider time and providing access to services in community practices where access to genetic services has been limited, providing opportunities to realize the promise of precision medicine in oncology.


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: 2026 ( Subtotal = -$871 )
2026	2024	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	5	1/6/2026	NON-COMPETING CONTINUATION	-$871
														Subtotal = -$871

Issue Date FY: 2024 ( Subtotal = $731,103 )
2024	2024	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	5	8/14/2024	NON-COMPETING CONTINUATION	$731,103
2024	2023	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	4	8/14/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $731,103

Issue Date FY: 2023 ( Subtotal = $785,824 )
2023	2023	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	4	9/20/2023	NON-COMPETING CONTINUATION	$785,824
2023	2022	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	3	8/16/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $785,824

Issue Date FY: 2022 ( Subtotal = $785,755 )
2022	2022	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	3	8/15/2022	NON-COMPETING CONTINUATION	$785,755
2022	2021	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	2	2/10/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $785,755

Issue Date FY: 2021 ( Subtotal = $800,208 )
2021	2021	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	2	9/1/2021	NON-COMPETING CONTINUATION	$800,208
														Subtotal = $800,208

Issue Date FY: 2020 ( Subtotal = $814,286 )
2020	2020	TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA, THE	3451 WALNUT ST STE 440A	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	9/17/2020	NEW	$814,286
														Subtotal = $814,286

Grand Total All Awards = $3,916,305

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A Randomized Hybrid Type I effectiveness-implementation study of an Ehealth delivery Alternative for Cancer genetic testing for Hereditary cancer predisposition (eREACH)

Award Number: U01CA243702

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/17/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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