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Comparative Effectiveness of Interventions to Increase Guideline-based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors

Award Number: R01CA211625
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/22/2016
PERIOD OF PERFORMANCE END DATE: 11/30/2023

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Comparative Effectiveness of Interventions to Increase Guideline-based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors - Genetic counseling or Cancer Genetic Risk Assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) is an evidence-based precision medicine strategy that facilitates informed decision making about effective health management options. Identification of individuals at increased risk of HBOC is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, treatment and survivorship. Although national guidelines for CGRA and genetic testing have been available for two decades, only one-third or less of high-risk women have accessed these services. The optimal risk assessment strategy starts with an individual with an HBOC-related cancer. Widespread dissemination and adoption of national guidelines for informed decision-making and promoting CGRA is needed to achieve a population-level reduction in cancer morbidity, mortality and disparities. Thus, it is important to promote access to CGRA, particularly in medically underserved populations. The proposed Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project seeks to address this important translational gap by developing and implementing strategies to promote guideline-based care in the Rocky Mountain region where there are distinguishable disparities in CGRA utilization by ethnicity and geography. Remarkably, few intervention studies have been conducted to address the regional and national translational gap in CGRA utilization for these diverse populations, underscoring our study's high impact and innovative public health intervention delivery approach. The GRACE Project is guided by evidenced-based behavior change counseling strategies to promote risk-based care delivery and reduce disparities that consider individual, cultural, social and system-level factors. The study's primary aim is to test the comparative effectiveness of mailed targeted print (TP) vs. TP plus a telephone-based tailored counseling and navigation intervention (TCN) vs. usual care (UC) to increase guideline-based CGRA for HBOC. We will oversample Hispanics and rural dwellers and enroll 1206 high-risk female cancer survivors. Women will be recruited through the Colorado and New Mexico cancer registries and meet the criteria for a CGRA referral. Enrollees will be randomized to one of 3 study arms and complete baseline, 1-month, 6-month and 12-month surveys. Specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored (TPC) intervention vs. usual care (UC) on CGRA utilization 6 months (primary outcome) after the intervention and at 12 months, after removal of key access barriers; 2) compare the effectiveness of the interventions on genetic testing utilization; 3) examine potential underlying theoretical mediating and moderating mechanisms that will further specify and elucidate significant intervention effects; and 4) compare the cost effectiveness of the interventions vs. usual care, for utilization of CGRA services. If effective, either or both interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination.


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 = $0 )
2024	2021	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	195 LITTLE ALBANY ST	NEW BRUNSWICK	NJ	08901	MIDDLESEX	USA	Cancer Cause and Prevention Research	000	5	4/10/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $0 )
2023	2021	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	195 LITTLE ALBANY ST	NEW BRUNSWICK	NJ	08903	MIDDLESEX	USA	Cancer Cause and Prevention Research	000	5	12/9/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2021 ( Subtotal = $618,436 )
2021	2021	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	195 LITTLE ALBANY ST	NEW BRUNSWICK	NJ	08903	MIDDLESEX	USA	Cancer Cause and Prevention Research	000	5	11/17/2020	NON-COMPETING CONTINUATION	$587,515
2021	2021	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	195 LITTLE ALBANY ST	NEW BRUNSWICK	NJ	08903	MIDDLESEX	USA	Cancer Cause and Prevention Research	001	5	1/22/2021	NON-COMPETING CONTINUATION	$30,921
														Subtotal = $618,436

Issue Date FY: 2020 ( Subtotal = $617,348 )
2020	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	195 LITTLE ALBANY ST	NEW BRUNSWICK	NJ	08903	MIDDLESEX	USA	Cancer Cause and Prevention Research	001	4	1/16/2020	NON-COMPETING CONTINUATION	$61,736
2020	2020	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	195 LITTLE ALBANY ST	NEW BRUNSWICK	NJ	08903	MIDDLESEX	USA	Cancer Cause and Prevention Research	000	4	11/6/2019	NON-COMPETING CONTINUATION	$555,612
														Subtotal = $617,348

Issue Date FY: 2019 ( Subtotal = $529,816 )
2019	2019	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	195 LITTLE ALBANY ST	NEW BRUNSWICK	NJ	08903	MIDDLESEX	USA	Cancer Cause and Prevention Research	003	3	12/21/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$592,927
2019	2019	RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY	195 LITTLE ALBANY ST	NEW BRUNSWICK	NJ	08903	MIDDLESEX	USA	Cancer Cause and Prevention Research	001	3	11/28/2018	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$529,816
2019	2018	UNIVERSITY OF NEW MEXICO	2500 MARBLE DR NE	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Cancer Cause and Prevention Research	002	2	12/21/2018	NON-COMPETING CONTINUATION	-$592,927
2019	2018	UNIVERSITY OF NEW MEXICO	2500 MARBLE DR NE	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Cancer Cause and Prevention Research	000	2	11/28/2018	NON-COMPETING CONTINUATION	$0
														Subtotal = $529,816

Issue Date FY: 2018 ( Subtotal = $608,440 )
2018	2018	UNIVERSITY OF NEW MEXICO	2500 MARBLE DR NE	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Cancer Cause and Prevention Research	000	2	12/6/2017	NON-COMPETING CONTINUATION	$547,596
2018	2018	UNIVERSITY OF NEW MEXICO	2500 MARBLE DR NE	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Cancer Cause and Prevention Research	001	2	5/23/2018	NON-COMPETING CONTINUATION	$60,844
														Subtotal = $608,440

Issue Date FY: 2017 ( Subtotal = $629,227 )
2017	2017	UNIVERSITY OF NEW MEXICO	2500 MARBLE DR NE	ALBUQUERQUE	NM	87131	BERNALILLO	USA	Cancer Cause and Prevention Research	000	1	12/22/2016	NEW	$629,227
														Subtotal = $629,227

Grand Total All Awards = $3,003,267

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Comparative Effectiveness of Interventions to Increase Guideline-based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors

Award Number: R01CA211625

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 12/22/2016

PERIOD OF PERFORMANCE END DATE: 11/30/2023

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