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Development and Implementation of ElectronicDecision Aids for Genetic Testing in Inherited Cancer Syndromes

Award Number: U01CA243695
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/14/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2025

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Development and Implementation of ElectronicDecision Aids for Genetic Testing in Inherited Cancer Syndromes - PROJECT SUMMARY The indications and demand for genetic testing in cancer care are rapidly growing. Hereditary cancer syndromes are more common than previously appreciated, and genetic testing is standard of care to establish these diagnoses. Genetic test results are also critical to guiding targeted therapies in patients with established tumors such as ovarian and pancreatic cancer. Genetic counselors have traditionally managed the testing process, but there is a critical shortage of counselors and they are not able to meet the demand for testing. Without a genetic counselor, effective communication of testing options, outcomes, and risks could be compromised. One of the most challenging decisions is the choice of gene panel. Multi- gene panels are now the norm, but panels can include as few as 5 or as many as 125 genes. Panels can include genes associated with a single tumor type or multiple tumor types, and genes with weaker evidence for pathogenicity may also be included. There is no consensus on what constitutes an ideal panel, and the choice of panel is therefore highly individualized. Innovative strategies to support patients facing these time-sensitive and complex pre-test decisions are needed. Decision aids are well-suited to address this challenge by providing education, facilitating the process of informed choice, clarifying personal preferences, and promoting shared decision making. We propose to develop an electronic decision aid to assist individuals in choosing a multi-gene panel with their medical oncologist instead of a genetic counselor. We will test the hypothesis that a decision aid without a genetic counselor can facilitate quality decisions around the selection of a specific multi-gene panel. In addition to positive changes in knowledge, shared decision making, and decisional conflict, we anticipate that the decision aid will increase access to genetic testing in a timely manner. Utilizing an effectiveness- implementation hybrid study design, we propose these specific aims: (1) To develop and pilot electronic decision aids for selection of a multi-gene panel in ovarian and pancreatic cancer patients. (2) To evaluate the efficacy of the decision aid with an oncologist versus a traditional genetic counselor session for multi- gene panel testing in a randomized clinical trial at multiple institutions. (3) To evaluate the effectiveness of implementation of the decision aid in multiple, diverse populations. These decision aids will establish a much needed and new paradigm for quality decision making and communication around multi-gene panel testing for inherited cancer syndromes. This format will uniquely address the current barriers that include the complex decision of which multi-gene panel to select, limited genetic counselor resources, and lack of time and expertise on the part of practicing oncologists.


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: 2025 ( Subtotal = $0 )
2025	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	4	3/21/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $493,563 )
2024	2024	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	5	8/29/2024	NON-COMPETING CONTINUATION	$493,563
2024	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	4	11/3/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $493,563

Issue Date FY: 2023 ( Subtotal = $737,088 )
2023	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	4	8/24/2023	NON-COMPETING CONTINUATION	$737,088
														Subtotal = $737,088

Issue Date FY: 2022 ( Subtotal = $597,088 )
2022	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	3	9/13/2022	NON-COMPETING CONTINUATION	$597,088
														Subtotal = $597,088

Issue Date FY: 2021 ( Subtotal = $761,599 )
2021	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	2	8/16/2021	NON-COMPETING CONTINUATION	$761,599
														Subtotal = $761,599

Issue Date FY: 2020 ( Subtotal = $778,073 )
2020	2020	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	001	1	9/16/2020	NEW	$0
2020	2020	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	21st Century Cures Act - Beau Biden Cancer Moonshot	000	1	9/14/2020	NEW	$778,073
														Subtotal = $778,073

Grand Total All Awards = $3,367,411

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Development and Implementation of ElectronicDecision Aids for Genetic Testing in Inherited Cancer Syndromes

Award Number: U01CA243695

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/14/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2025

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