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R01CA303651

Project Grant

Overview

Grant Description
PATIENT NAVIGATION FOR IMPROVING TRANSITION SUCCESS AMONG MULTIPLY DISADVANTAGED YOUNG ADULT SURVIVORS OF CHILDHOOD CANCER - IN RECENT YEARS, AGGREGATE 5-YEAR SURVIVAL AFTER CHILDHOOD CANCER SURPASSED 85% AND AT LEAST 500,000 INDIVIDUALS LIVING IN THE US ARE CHILDHOOD CANCER SURVIVORS (CCS). UNFORTUNATELY, TREATMENT-RELATED LATE EFFECTS OCCUR IN MORE THAN TWO THIRDS OF CCS AND IN HALF ARE SEVERE OR LIFE-THREATENING, WITH A STEADILY RISING CUMULATIVE INCIDENCE THAT RESULTS IN PREMATURE MORTALITY, EXCESS MORBIDITY, PSYCHOSOCIAL DISTRESS, AND LOWER QUALITY OF LIFE. GIVEN THIS LIFE-LONG BURDEN, FORMAL TRANSITION OF SURVIVORSHIP CARE FROM PEDIATRIC TO ADULT-FOCUSED PROVIDERS IS RECOMMENDED FOR CCS TO ENSURE CONTINUATION OF MEDICALLY AND DEVELOPMENTALLY APPROPRIATE MANAGEMENT OVER THE LIFE SPAN. DESPITE THIS, USE OF VARIOUS TRANSITIONAL CARE MODELS, KNOWLEDGE OF KEY TRANSITION BARRIERS AND FACILITATORS, AND THE AVAILABILITY OF PUBLISHED GUIDELINES FOR LATE EFFECTS SCREENING INTO ADULTHOOD HAVE LARGELY FAILED TO ACHIEVE SUCCESSFUL TRANSITION AND OPTIMAL SURVIVORSHIP CARE FOR MOST YOUNG ADULT CCS. THESE ISSUES ARE EXACERBATED AMONG CCS WHO ARE LOW SES AND ARE UNDER/UNINSURED. FURTHERMORE, EMERGING EVIDENCE SHOWS THAT CCS REPORT HIGH UNMET HEALTH-RELATED SOCIAL NEEDS (HRSN) SUCH AS FINANCIAL HARDSHIP, FOOD INSECURITY, LACK OF TRANSPORTATION, LOW HEALTH INSURANCE LITERACY, AND PSYCHOLOGICAL BURDEN. SUCH SURVIVORS REPRESENT A POPULATION AT EVEN HIGHER RISK OF EARLY FOLLOW-UP ATTRITION, LOWER RETENTION IN GUIDELINE-CONCORDANT CARE, AND DOWNSTREAM ADVERSE IMPACTS ON HEALTH STATUS. PATIENT NAVIGATION IS AN INTERVENTION THAT HAS ROBUST EVIDENCE IN ADULT CANCER PREVENTION AND TREATMENT BUT HAS NOT BEEN STUDIED FOR IMPROVING SURVIVORSHIP TRANSITION AMONG CCS. THE OVERALL HYPOTHESIS IS THAT A HRSN-INFORMED PATIENT NAVIGATOR (PN) TRANSITION INTERVENTION WILL BE EFFECTIVE IN IMPROVING RATES OF SUCCESSFUL TRANSITION FOR CCS. IN THIS PROPOSED STUDY CONDUCTED AT A SAFETY NET CHILDREN’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
Funding Goals
TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS, (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION, (3) EPIDEMIOLOGY, (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS, (5) IMMUNOLOGY AND VACCINES, (6) FIELD STUDIES AND STATISTICS, (7) CANCER CHEMOPREVENTION AND INTERCEPTION, (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT, (9) ORGAN SITE STUDIES AND CLINICAL TRIALS, (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES, AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO STIMULATE TECHNICAL INNOVATION, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.
Place of Performance
California United States
Geographic Scope
State-Wide
Children's Hospital Los Angeles was awarded Patient Navigation for Young Adult CCS Transition Project Grant R01CA303651 worth $4,236,812 from National Cancer Institute in September 2025 with work to be completed primarily in California United States. The grant has a duration of 4 years and was awarded through assistance program 93.393 Cancer Cause and Prevention Research. The Project Grant was awarded through grant opportunity Addressing Barriers to Healthcare Transitions for Survivors of Childhood and Adolescent Cancers (R01 Clinical Trial Optional).

Status
(Ongoing)

Last Modified 9/24/25

Period of Performance
9/10/25
Start Date
8/31/29
End Date
1.0% Complete

Funding Split
$4.2M
Federal Obligation
$0.0
Non-Federal Obligation
$4.2M
Total Obligated
100.0% Federal Funding
0.0% Non-Federal Funding

Activity Timeline

Interactive chart of timeline of amendments to R01CA303651

Additional Detail

Award ID FAIN
R01CA303651
SAI Number
R01CA303651-2434618812
Award ID URI
SAI UNAVAILABLE
Awardee Classifications
Nonprofit With 501(c)(3) IRS Status (Other Than An Institution Of Higher Education)
Awarding Office
75NC00 NIH National Cancer Institute
Funding Office
75NC00 NIH National Cancer Institute
Awardee UEI
DVL1CMRMWRN9
Awardee CAGE
0RMZ8
Performance District
CA-90
Senators
Dianne Feinstein
Alejandro Padilla
Modified: 9/24/25