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Testing scalable communication modalities for returning breast cancer genetic research results to African American women

Award Number: R01MD014312
ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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ABSTRACT National initiatives in precision medicine, such as the All of Us Research Program, have set ambitious plans to establish a research cohort of one million or more participants and enable a new era of medicine that empowers patients, researchers, and providers to work together toward development of individualized treatments. A central challenge to large-scaled precision medicine research is the return of individual genetic research results to study participants. Yet, approaches to scale the return of clinically actionable genetic results to large cohorts have not been well-tested to date. The magnitude of this endeavor has renewed concerns about the shortage of qualified genetic counselors for this task. Rigorous research efforts are thus needed to test the efficacy of alternate models for genetic results disclosure, which has widespread implications for how precision medicine research might yield direct benefits for study participants. We propose to conduct a randomized controlled trial (RCT) within the Black Women's Health Study (BWHS) to test alternate communication modalities for results disclosure. The BWHS is an ongoing prospective cohort study of 59,000 self-identified black women from across the United States who have been followed since 1995. Targeted sequencing of over 4000 women within the cohort for BRCA1/2 and other known or suspected high and moderate penetrance genes opens up the possibility of returning breast cancer genetic results to BWHS participants and examining the clinical utility of genetic results return. The primary aim of the proposed research project is to compare the efficacy of two communication modalities for returning breast cancer genetic research results to African American women: 1) a conventional modality that entails telephone disclosure by a licensed genetic counselor, and 2) an online self-guided modality that entails returning results directly to participants, with optional genetic counselor follow-up via telephone. Secondary aims of this study will examine 1) moderators of the intervention impact and 2) psychosocial, sociodemographic, and clinical predictors of result uptake. This study is uniquely situated to provide critical empirical evidence on the effectiveness of alternate models for genetic results return and provide further insight into the factors influencing uptake of genetic information among African American women. Study findings will inform ongoing efforts to establish scalable approaches for effective return of genetic research results, and increase access to personal health information among African American women.


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 = $700,424 )
2024	2024	TRUSTEES OF BOSTON UNIVERSITY	85 EAST NEWTON ST # M-921	BOSTON	MA	02118	SUFFOLK	USA	Minority Health and Health Disparities Research	001	4	12/22/2023	NON-COMPETING CONTINUATION	$700,424
2024	2022	TRUSTEES OF BOSTON UNIVERSITY	85 EAST NEWTON ST # M-921	BOSTON	MA	02118	SUFFOLK	USA	Minority Health and Health Disparities Research	000	3	12/20/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $700,424

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2022	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Minority Health and Health Disparities Research	001	3	1/26/2023	NON-COMPETING CONTINUATION	$0
2023	2021	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Minority Health and Health Disparities Research	000	2	1/26/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2022 ( Subtotal = $619,206 )
2022	2022	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Minority Health and Health Disparities Research	000	3	4/26/2022	NON-COMPETING CONTINUATION	$619,206
														Subtotal = $619,206

Issue Date FY: 2021 ( Subtotal = $1,043,560 )
2021	2021	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Minority Health and Health Disparities Research	004	2	3/15/2021	NON-COMPETING CONTINUATION	$0
2021	2021	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Minority Health and Health Disparities Research	003	2	3/11/2021	NON-COMPETING CONTINUATION	$72,661
2021	2021	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Minority Health and Health Disparities Research	001	2	1/22/2021	NON-COMPETING CONTINUATION	$653,949
2021	2021	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Minority Health and Health Disparities Research	005	2	7/26/2021	NON-COMPETING CONTINUATION	$316,950
2021	2020	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Minority Health and Health Disparities Research	000	1	1/21/2021	NEW	$0
2021	2020	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Minority Health and Health Disparities Research	002	1	1/25/2021	NEW	$0
														Subtotal = $1,043,560

Issue Date FY: 2020 ( Subtotal = $692,749 )
2020	2020	TRUSTEES OF BOSTON UNIVERSITY	85 E NEWTON ST M-921	BOSTON	MA	02118	SUFFOLK	USA	Minority Health and Health Disparities Research	000	1	6/12/2020	NEW	$692,749
														Subtotal = $692,749

Grand Total All Awards = $3,055,939

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Testing scalable communication modalities for returning breast cancer genetic research results to African American women

Award Number: R01MD014312

ORGANIZATION: NATIONAL CENTER ON MINORITY HEALTH AND HEALTH DISPARITIES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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