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Optimization of a remote intervention to improve nutrition and physical activity in colorectal cancer survivors

Award Number: R37CA248774
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/10/2020
PERIOD OF PERFORMANCE END DATE: 11/30/2025

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Optimization of a remote intervention to improve nutrition and physical activity in colorectal cancer survivors - Colorectal cancer (CRC) is the 2nd leading cause of cancer death in the United States. The American Cancer Society (ACS) recommends normal body mass index (BMI), regular physical activity, and a healthy diet for cancer survivors. In 2018, we estimated that 38% of deaths within 5 years of diagnosis could be prevented in stage III colon cancer if all patients followed the ACS guidelines. Yet, <10% of CRC patients closely follow these lifestyle guidelines. Investigators have yet to optimize a lifestyle intervention, capitalizing on effective scalable components, to improve lifestyle behaviors in CRC survivors. Critical research gaps include: 1) whether specific intervention components (e.g., text messaging, etc.) are effective, overall or in sub-groups (men vs. women, etc.); 2) insufficient focus on improving diet; and 3) few studies with remote interventions have measured biological outcomes. To address these gaps, we propose to use the multiphase optimization strategy (MOST) framework to identify effective intervention components to increase the ACS guideline score (a standardized measure of physical activity, diet, and body size) among CRC survivors. The MOST framework is an engineering-based approach to efficiently optimize behavioral interventions while managing limited resources. Our team at the University of California, San Francisco; Dana-Farber Cancer Institute; and Northwestern University have strong expertise conducting lifestyle interventions in cancer survivors, including using MOST. Building on this experience, we propose a 12-month (mo.) randomized factorial experiment among 400 CRC survivors to determine the effect of 4 candidate intervention components [text messaging, digital health tool kit (physical activity tracker, apps), health coaching, buddy training (e.g., friend, family)] on change in the ACS guideline score from 0 to 12 mo. Changes in the ACS score (our primary outcome) have high potential to impact CRC survival, and it is modifiable and measurable remotely. Our Specific Aims are to: Aim 1) Identify which of 4 candidate intervention components increase the ACS guideline score at 12 mo. among CRC survivors. We will determine the individual and interaction effects of each component. Secondarily, we aim to: Aim 2) Examine mediators and moderators of the intervention components’ effects on change in the ACS guideline score from 0 to 12 mo. We will examine social cognitive theory constructs as primary target mediators and sociodemographic, clinical, and psychological/behavioral factors as potential moderators. This aim will help us understand how and for whom the intervention components affect lifestyle behaviors. Aim 3) Examine the ACS guideline score in relation to levels of fasting insulin, glucose, HOMA-IR and inflammatory markers at enrollment and 12 mo. The data from all three aims of this proposal will guide our next step to conduct a definitive randomized controlled trial to evaluate the effect of the optimized intervention versus standard care on risk of CRC recurrence. Overall, this proposal is a critical step toward developing an effective and scalable lifestyle intervention to reduce CRC mortality with potential for high public health impact.


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 = $606,425 )
2025	2025	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	5	12/6/2024	NON-COMPETING CONTINUATION	$606,425
														Subtotal = $606,425

Issue Date FY: 2024 ( Subtotal = $771,481 )
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	4	11/16/2023	NON-COMPETING CONTINUATION	$608,203
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	002	4	4/16/2024	NON-COMPETING CONTINUATION	$33,787
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94103	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	003	4	4/16/2024	SUPPLEMENT FOR EXPANSION	$6,816
2024	2024	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	001	4	11/27/2023	SUPPLEMENT FOR EXPANSION	$122,675
														Subtotal = $771,481

Issue Date FY: 2023 ( Subtotal = $859,825 )
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	3	12/13/2022	NON-COMPETING CONTINUATION	$607,154
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	002	3	1/24/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	001	3	12/19/2022	SUPPLEMENT FOR EXPANSION	$198,702
2023	2023	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	003	3	3/22/2023	NON-COMPETING CONTINUATION	$53,969
														Subtotal = $859,825

Issue Date FY: 2022 ( Subtotal = $760,258 )
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	001	2	4/28/2022	NON-COMPETING CONTINUATION	$67,580
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	2	12/17/2021	NON-COMPETING CONTINUATION	$608,220
2022	2022	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	002	2	6/10/2022	SUPPLEMENT FOR EXPANSION	$84,458
														Subtotal = $760,258

Issue Date FY: 2021 ( Subtotal = $705,777 )
2021	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	001	1	4/1/2021	NEW	$0
2021	2021	REGENTS OF THE UNIVERSITY OF CALIFORNIA, SAN FRANCISCO, THE	1855 FOLSOM ST STE 425	SAN FRANCISCO	CA	94143	SAN FRANCISCO	USA	Cancer Detection and Diagnosis Research	000	1	12/10/2020	NEW	$705,777
														Subtotal = $705,777

Grand Total All Awards = $3,703,766

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Optimization of a remote intervention to improve nutrition and physical activity in colorectal cancer survivors

Award Number: R37CA248774

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 12/10/2020

PERIOD OF PERFORMANCE END DATE: 11/30/2025

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