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Development and Initial Testing of a Behavioral Intervention to Increase Pre-Test Genetic Counseling Among Families at Risk of Lynch Syndrome

Award Number: R00CA277584
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2023
PERIOD OF PERFORMANCE END DATE: 08/31/2027

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Development and Initial Testing of a Behavioral Intervention to Increase Pre-Test Genetic Counseling Among Families at Risk of Lynch Syndrome - PROJECT SUMMARY Lynch syndrome (LS) is an inherited cancer predisposition syndrome that substantially elevates lifetime risks for multiple cancers in both men and women. Identifying people with LS enables more frequent and earlier cancer surveillance and prevention, which can effectively reduce LS-related cancer morbidity and mortality. However, most people with LS in the United States are not diagnosed. One cost-effective way to identify individuals with LS is by conducting genetic testing on blood relatives of patients diagnosed with LS (or “cascade testing”), but the testing rate is low. Pre-test genetic counseling is a promising means to address many of the barriers to testing and to increase testing uptake. However, pre-test genetic counseling uptake is low in relatives at risk of LS, and the barriers and facilitators have not been systematically studied. Although informational resources for LS genetic counseling exist, they are unlikely to be sufficient for motivating behavior change. Aligned with the National Cancer Institute’s focus on cancer research to advance scientific knowledge and help all people live longer, healthier lives, the proposed research will address these critical gaps through three aims: 1) Identify barriers and facilitators to pre-test genetic counseling among relatives with no personal history of cancer but at risk of LS; 2) Develop a theory-based behavioral intervention to increase pre-test genetic counseling uptake in this population; and 3) Evaluate and optimize feasibility of the trial methods and the behavioral intervention to prepare for a fully powered randomized controlled trial and explore the intervention’s preliminary efficacy. I will apply the Behavior Change Wheel, a well-established behavior change framework, and use mixed methods (i.e., focus groups, usability testing, and a randomized controlled pilot trial) to develop a behavioral intervention to increase pre-test genetic counseling uptake. The proposed research will lead to an R01 proposal to test the efficacy of the intervention. My study team consists of outstanding mentors who have recognized expertise in the methodologies and topic areas of the proposed research, and a genetic counselor who will ensure that the research is clinically grounded. In coordination with my research activities, my career development plan includes structured training and one-on-one mentoring in behavioral medicine and intervention design and development, design and conduct of clinical trials, qualitative methods, and grant writing and management. Along with the abundant research and training resources and the supportive environment for transitioning early-career researchers to independence at Northwestern University Feinberg School of Medicine and Department of Medical Social Sciences, this K99/R00 will enable me to become an independent investigator working to facilitate decision making in patients and other stakeholders who face difficult cancer-related decisions, including those involving genetic risks.


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 = $429,699 )
2025	2025	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	000	3	3/4/2025	EXTENSION WITH OR WITHOUT FUNDS	$180,699
2025	2025	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	001	4	8/13/2025	NON-COMPETING CONTINUATION	$180,699
2025	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	000	3	3/4/2025	EXTENSION WITH OR WITHOUT FUNDS	$68,301
														Subtotal = $429,699

Issue Date FY: 2024 ( Subtotal = $249,000 )
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	000	3	9/4/2024	EXTENSION WITH OR WITHOUT FUNDS	$249,000
2024	2024	UNIVERSITY OF ALABAMA AT BIRMINGHAM	701 S 20TH STREET	BIRMINGHAM	AL	35294	JEFFERSON	USA	Cancer Treatment Research	001	3	9/9/2024	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $249,000

Grand Total All Awards = $678,699

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Development and Initial Testing of a Behavioral Intervention to Increase Pre-Test Genetic Counseling Among Families at Risk of Lynch Syndrome

Award Number: R00CA277584

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/01/2023

PERIOD OF PERFORMANCE END DATE: 08/31/2027

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