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Improving Delivery of Genetic Services to High Risk Childhood Cancer Survivors: A Randomized Study of Remote Genetic Services Versus Usual Care

Award Number: R01CA237369
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/08/2020
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Improving Delivery of Genetic Services to High Risk Childhood Cancer Survivors: A Randomized Study of Remote Genetic Services Versus Usual Care - PROJECT SUMMARY Germline cancer genetic testing has become a standard evidence-based practice, with risk reduction and cancer screening guidelines for genetic carriers. Yet, many at-risk patients do not have access to genetic services, leaving many genetic carriers unidentified. Given increasing precision medicine applications, and a limited and geographically restricted workforce of genetic providers, innovative delivery models for genetic services that are responsive to the needs of geographically and sociodemographically diverse patient populations in their local health care systems are needed. Suboptimal access to genetic services is an acute problem for childhood cancer survivors, who have high rates of subsequent malignant neoplasms (SMN). Studies indicate that >10% of survivors carry a pathogenic or likely pathogenic germline mutation in cancer susceptibility genes (eg. TP53, BRCA ½). In order to identify high-risk survivors for early surveillance and intervention, NCCN and Children's Oncology Group Guidelines recommend that survivors with a personal and/or family history of cancer be referred for genetic services. However, <15% of these survivors have access to genetic counseling services and both survivors and their Primary Care Providers (PCPs) are largely unaware of their health risks and thus, adherence to high-risk surveillance guidelines is low. Our studies in adult patients with a personal or family history of cancer suggest that remote telegenetic services (by phone or videoconferencing) may increase access to genetic services and identification of genetic mutation carriers. Yet, our current studies have examined these models partnering on-site with community oncology practices, limiting scalability. This is of particular importance for childhood cancer survivors, who are widely distributed nationally and >85% are receiving their care with PCPs. Thus, our premise is that our adapted in-home, collaborative PCP model of remote telegenetic services can provide a scalable model that will result in increased uptake of evidence-based recommendations for cancer genetic services in survivors. We propose a 3-arm randomized Hybrid 1 effectiveness and implementation study in the Childhood Cancer Survivor Study (CCSS) to evaluate the effectiveness of our in-home, collaborative PCP model of remote telegenetic services to increase uptake of cancer genetic testing in childhood cancer survivors compared to usual care (Aim 1), to evaluate the effectiveness of videoconferencing to provide greater increase in knowledge, and decrease in distress and depression as compared to remote phone services (Aim 2a), the moderators of patient outcomes (Aim 2b), and a cost evaluation of the three study arms (Aim 2c). Also, we will conduct a multi-stakeholder mixed-methods implementation evaluation to understand patient, provider and system factors associated with uptake of our remote telegenetic services model, facilitators and barriers to uptake, and recommendations for future adaptation and sustainability (Aim 3). We expect our findings will provide critical data for the basis for further dissemination of these services among cancer survivors and other populations in need of genetic services.


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 = -$1,744 )
2026	2024	UNIVERSITY OF CHICAGO	5801 S ELLIS AVE	CHICAGO	IL	60637	COOK	USA	Cancer Cause and Prevention Research	000	5	12/2/2025	NON-COMPETING CONTINUATION	-$1,744
														Subtotal = -$1,744

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	UNIVERSITY OF CHICAGO	5801 S ELLIS AVE	CHICAGO	IL	60637	COOK	USA	Cancer Cause and Prevention Research	000	5	7/23/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $579,447 )
2024	2024	UNIVERSITY OF CHICAGO	5801 S ELLIS AVE	CHICAGO	IL	60637	COOK	USA	Cancer Cause and Prevention Research	000	5	6/4/2024	NON-COMPETING CONTINUATION	$579,447
														Subtotal = $579,447

Issue Date FY: 2023 ( Subtotal = $658,129 )
2023	2023	UNIVERSITY OF CHICAGO	5801 S ELLIS AVE	CHICAGO	IL	60637	COOK	USA	Cancer Cause and Prevention Research	000	4	6/28/2023	NON-COMPETING CONTINUATION	$658,129
														Subtotal = $658,129

Issue Date FY: 2022 ( Subtotal = $661,824 )
2022	2022	UNIVERSITY OF CHICAGO	5801 S ELLIS AVE	CHICAGO	IL	60637	COOK	USA	Cancer Cause and Prevention Research	000	3	8/31/2022	NON-COMPETING CONTINUATION	$661,824
														Subtotal = $661,824

Issue Date FY: 2021 ( Subtotal = $694,312 )
2021	2021	UNIVERSITY OF CHICAGO, THE	5801 S ELLIS AVE	CHICAGO	IL	60637	COOK	USA	Cancer Cause and Prevention Research	000	2	6/30/2021	NON-COMPETING CONTINUATION	$694,312
														Subtotal = $694,312

Issue Date FY: 2020 ( Subtotal = $764,736 )
2020	2020	UNIVERSITY OF CHICAGO, THE	5801 S ELLIS AVE	CHICAGO	IL	60637	COOK	USA	Cancer Cause and Prevention Research	000	1	7/7/2020	NEW	$764,736
														Subtotal = $764,736

Grand Total All Awards = $3,356,704

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Improving Delivery of Genetic Services to High Risk Childhood Cancer Survivors: A Randomized Study of Remote Genetic Services Versus Usual Care

Award Number: R01CA237369

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/08/2020

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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