Childhood Cancer STAR (Survivorship, Treatment, Access, Research) Act (Public Law No: 115-180) and the Childhood Cancer STAR Reauthorization Act (Public Law No: 117-350)

• The Childhood Cancer STAR Act (signed into law on 6/05/2018) authorizes NCI to support and expand collection of biospecimens from children and AYAs diagnosed with cancer to build upon biorepositories and biospecimen research already underway with NCI support. The bill encourages that these efforts focus on cancer types/subtypes (and their recurrences) for which current treatments are least effective and occur within the context of clinical trials.
• The law also authorizes NIH, with guidance from the NCI Director and in coordination with ongoing research activities, to continue to conduct and support pediatric cancer survivorship research and includes an emphasis on studying late effects of pediatric cancer treatment, as well as disparities in outcomes and barriers to follow-up care.
• Other provisions specific to NIH and NCI include requiring that at least one member of the presidentially appointed National Cancer Advisory Board be knowledgeable in pediatric oncology; reaffirming reporting requirements for NIH in addressing pediatric oncology research within congressional reporting, including its annual Pediatric Research Initiative Report to Congress; and expressing the sense of Congress that the NCI Director should ensure that all applicable study sections, committees, advisory groups, and panels at NCI should include one or more qualified pediatric oncologists, as appropriate.
• The law also authorizes HHS, through the Centers of Disease Control and Prevention, to award grants to state cancer registries to expand surveillance infrastructure to track the epidemiology of cancer in children and AYAs.
• The Childhood Cancer STAR Reauthorization Act was signed into law on 1/5/2023 and reauthorized continued implementation of the original bill from fiscal year (FY) 2024-2028. Provisions in the law call for a research initiative to evaluate delivery of childhood and AYAs survivorship care, and for NCI to provide a report to Congress on researchers’ access to biospecimens. 
• The legislation was introduced in the House as H.R. 7630 by Reps. Michael McCaul (R-TX), and Mike Kelly (R-PA), along with retired Reps. Jackie Speier (D-CA), and G.K. Butterfield (D-NC) on 4/28/2022. Senators Jack Reed (D-RI), Shelley Moore Capito (R-WV), Chris Van Hollen (D-MD), and Lisa Murkowski (R-AK) introduced a companion bill, S. 4120, in the Senate on the same date.
• Read the full bill text for the STAR Act and the STAR Reauthorization Act on Congress.gov.

 

Implementation:

NCI is currently supporting implementation of several Childhood Cancer STAR Act provisions that are directed toward the Institute. As encouraged in Section 202 of the STAR Act, in addition to continuing to conduct and support childhood, adolescent, and young adult (AYA) cancer survivorship research, NCI is also expanding support in this area for new research projects, as described in more detail below. NCI is also working to enhance biospecimen collection, biobanking, and related resources for childhood and AYA cancers, with an emphasis on those cancer types and subtypes for which treatments are least effective, as specifically encouraged in Section 101 of the STAR Act. NCI convened a meeting on 05/13/2019 with more than 50 representatives from across the childhood cancer research and advocacy communities, focused on challenges and opportunities in this field. More information about the meeting proceedings, including presentations and discussion, is available here in the "Enhancing Biobanking for Childhood Cancers Meeting Minutes". The Institute has identified several additional efforts to enhance biospecimen collection and biobanking across its childhood cancer research programs, as summarized below and described in more detail in the Report to Congress on Biobanking Projects Supported through the NCI’s Implementation of Section 101. The report provides an overview of the complementary biobanking research efforts that NCI supports through the STAR Act and through additional investments in childhood and AYA biospecimen collection and biobanking resources.

• New biospecimen research projects: NCI continues to support several new projects through the Children’s Oncology Group (COG) to focus attention to rare cancer subtypes that are currently underrepresented in NCI-supported biorepositories, as well as tumor types with a high risk of treatment failure. NCI also recently initiated a new 5-year grant to support the COG Biorepository. This ongoing support is being funded in addition to NCI’s investment in STAR Act biobanking projects. NCI is also supporting new biobanking projects for the Childhood Cancer Survivors Study (CCSS), to enhance and support further research focused on subsequent cancers and chronic health conditions. Additionally, childhood cancer researchers have requested and used biospecimens from STAR Act funded supplement projects for 11 new research projects, with 10 of these projects supported by NCI (in addition to the STAR Act investments described here) and one supported by the Cancer Prevention and Research Institute of Texas. Biospecimens will continue to be available for researchers in the coming years with continued support.

  • COG – Rare Tumor Populations Biobanking: For rare cancers for which COG does not have open clinical trials, tumor tissue collection options are limited. This program expanded in FY2021 and supports tumor tissue and blood collection for specific groups of patients for which current tumor tissue collection is lacking or inadequate, with priority for tumor types with high risk of treatment failure. This initiative also collaborates closely with the Childhood Cancer Data Initiative (CCDI) to analyze tumor tissue to obtain a clinically relevant molecular profiling through the CCDI Molecular Characterization Protocol. The data helps this Protocol support characterization of tumors for rare cancers, Central Nervous System (CNS) tumors as well as soft tissue sarcomas.

  • COG – Tumor Specimens from Patients at Relapse: An important impediment to understanding mechanisms of treatment failure for childhood solid tumors is the limited numbers of paired specimens from both diagnosis and relapse that are available for researchers to study. Specimens at relapse are critical for evaluating biological changes between diagnosis and relapse that can lead to the identification of mechanisms of treatment failure and to the development of strategies for circumventing these mechanisms. One area of focus is the collection of relapse specimens from children with rhabdomyosarcoma.

  • COG – Rapid Autopsy Specimen Collection: NCI and COG continue to work with patient organizations to support rapid autopsy collection of tumor samples from children and AYAs who have died of their disease. Foundations and families within the pediatric brain tumor community have been leaders in such programs, and we hope to learn from their experiences to expand this model to other childhood cancers. We are incredibly grateful to these parents and caregivers, who amidst unimaginable grief and loss, contribute to future research to help other families.

  • COG – Pediatric MATCH Diagnostic Specimen Collection: This effort collects diagnostic samples for children and AYAs who have already submitted samples at relapse through NCI’s Pediatric MATCH Trial and enables molecular characterization to identify the changes in gene mutations and gene expression that occur between diagnosis and relapse. This in-depth characterization aims to inform development of more relevant treatments.

  • CCSS Biobanking I –  Specimen Collection of Subsequent Cancers: The development of subsequent malignant neoplasms (SMN) is associated with significant morbidity and mortality for survivors of childhood cancer. The CCSS has prioritized collection of SMN somatic tissue specimens (tissue blocks, scrolls, slides) from survivors with confirmed cases of subsequent malignancies. The results help design treatment protocols and interventions that will result in an increase in survival, while minimizing harmful late effects. This research is also used to develop and expand programs for early detection and prevention of late effects in children and adolescent cancer survivors.

  • CCSS Biobanking II –  Specimen Collection to Study Chronic Health Conditions: This project will enhance the CCSS as a resource for future biologic and genetic evaluations to better understand the causes of chronic health conditions in survivors of childhood cancer.

• New survivorship research projects: NCI issued a new request for applications (RFA) in March 2020, titled “Research to Reduce Morbidity and Improve Care for Pediatric, and Adolescent and Young Adult (AYA) Cancer Survivors” (RFA-CA-20-027/028), which builds upon a previous RFA (RFA-CA-19-033), to continue to address survivorship research areas emphasized in the STAR Act. NCI funded eight projects in response to RFA-CA-19-033 in FY2020, and ten projects in response to RFA-CA-20-027/028 in FY2021. NCI funded an additional final round of thirteen awards in FY2022. These efforts aim to improve care and health-related quality of life for childhood and AYA cancer survivors, through mechanistic, observational, and intervention research projects that focus on six key domains: (1) disparities in survivor outcomes; (2) barriers to follow-up care; (3) impact of familial, socioeconomic, and other environmental factors on survivor outcomes; (4) indicators for long-term follow-up needs related to risk for late effects, recurrence, and subsequent cancers; (5) risk factors and predictors of late/long-term effects of cancer treatment; and (6) development of targeted interventions to reduce the burden of cancer for pediatric/AYA survivors. More information about each project supported through these rounds of awards is provided in the tables below.

RFA-CA-19-033: Improving outcomes for Pediatric, Adolescent, and Young Adult Cancer Survivors  Project Title, Principal Investigator, Institution, Grant Type	Tumor Types	Late/Long Term Effect(s)
Using Information Technology to Improve Outcomes for Children Living with Cancer  PI: Dr. Jin-Shei Lai (Northwestern University at Chicago), U01	All	Disease and treatment-related symptoms
A Randomized Trial of a Mobile Health and Social Media Physical Activity Intervention Among AYA Childhood Cancer Survivors   PI: Dr. Nina Kadan-Lottick (Yale University), U01	All	Sedentary behavior
Utility Of Memantine In Preventing Cognitive Dysfunction In Children Receiving Cranial Radiotherapy PI: Dr. Nadia Laack (Mayo Clinic), U01	Primary brain tumors	Cognitive dysfunction after cranial radiotherapy
A web-based patient-reported symptom monitoring and self-management portal for AYA breast cancer survivors PI: Dr. Ann Partridge (Dana-Farber), U01	Breast cancer	Symptoms, unmet needs, concerns
Telehealth based exercise intervention to improve functional capacity in survivors of childhood cancer with significantly limited exercise tolerance  PI: Dr. Kirsten Ness (St. Jude), U01	All	Reduced exercise capacity, impaired physical dysfunction
An INteractive Survivorship Program to Improve Healthcare REsources [INSPIRE] for Adolescent and Young Adult (AYA) Cancer Survivors PI: Dr. Karen Syrjala (Fred Hutchinson), U01	All	Emotional distress; adherence
Implementation of a Provider-Focused Intervention for Maximizing HPV Vaccine Uptake in Young Cancer Survivors receiving Follow-Up Care in Pediatric Oncology Practices: A Cluster-Randomized Trial PI: Dr. Wendy Landier (University of Alabama), U01	All	Elevated risk of HPV-related complications & malignancies
Sen-Survivors: An open-label intervention trial for frailty and senescence PI: Dr. Gregory Armstrong (St. Jude Children’s Research Hospital), U01	All	Frailty, chronic health conditions

RFA-CA-20-027/028: Research to Reduce Morbidity and Improve Care for Pediatric, and Adolescent and Young Adult (AYA) Cancer Survivors  Project Title, Principal Investigator, Institution, Grant Type	Target Population	Topic Area
Predicting and Preventing Chemotherapy-Induced Cardiotoxicity in African American Children  PI: Drs. Paul W Burridge and Yadav Sapkota (Northwestern University at Chicago), R01	African American, doxorubicin-treated childhood cancer survivors	Cardiotoxicity
Bridging Information Divides and Gaps to Ensure Survivorship: The BRIDGES Randomized Controlled Trial of a Multilevel Intervention to Improve Adherence to Childhood Cancer Survivorship  PI: Dr. Nina S Kadan-Lottick (Georgetown University), R01	Childhood cancer survivors and primary care providers	Follow-up care
Social Genomic Mechanisms of Health Disparities Among Adolescent and Young Adult (AYA) Cancer Survivors  PI: Dr. Bradley Jay Zebrack (University of Michigan at Ann Arbor), R01	Non-Hodgkin’s lymphoma and Hodgkin’s lymphoma survivors	Social determinants of health
SALSA – Study of Active Lifestyle Activation  PI: Dr. Eric Jessen Chow (Fred Hutchinson Cancer Research Center), R01	Childhood cancer survivors	Cardiovascular disease
Individual, Cultural, and Area-Based Factors Associated with Survivorship Care Among Asian/Asian American Childhood Cancer Survivors  PI: Drs. Kimberly Ann Miller and Joel E Milam (University of Sothern California), R01	Asian and Asian American Childhood cancer survivors	Follow-up care
Optimization of a mHealth Physical Activity Promotion Intervention with Mindful Awareness for Adolescent and Young Adult Cancer Survivors  PI: Drs. Siobhan Marie Phillips and David Victorson (Northwestern University at Chicago), R01	Childhood and AYA cancer survivor	Quality of life
Pilot Test of an mHealth Intervention for Reducing Alcohol Use Among Rural Adolescent and Young Adult Cancer Survivors  PI: Drs. Carolyn Lauckner and Laurie Mclouth (University of Kentucky), R21	Rural AYA cancer survivors	Alcohol consumption
Treatment-Specific Genetic Risk Scores for Late Effects Prediction in Childhood, Adolescent, and Young Adult Cancer Survivors  PI: Drs. Cindy Im and Yan Yuan (University of Alberta), R21	Childhood cancer survivors	Risk for chronic conditions
Remote Monitoring of Cardiac Function in Childhood Cancer Survivors  PI: Dr. Saro Armenian (Beckman Research Institute/City of Hope), R21	Anthracycline-exposed, long-term childhood cancer survivors	Cardiac dysfunction
Caregiving For Young Adults with Cancer in Latino Families: Understanding Healthcare Engagement and Family Wellbeing PI: Dr. Michael A Hoyt (University of California-Irvine), R21	Latino AYA cancer survivors and their families and providers	Caregiving

RFA-CA-20-027/028: Research to Reduce Morbidity and Improve Care for Pediatric, and Adolescent and Young Adult (AYA) Cancer Survivors  Project Title, Principal Investigator, Institution, Grant Type	Target Population	Topic Area
Personalized Risk Prediction to Reduce Cardiovascular Disease in Childhood Cancer Survivors PI: Drs. Rebecca Maureen Howell, Daniel A. Mulrooney, and Yutaka Mulrooney (University of Texas MD Anderson Cancer Center), R01	Radiotherapy-treated childhood Hodgkin lymphoma survivors	Cardiovascular disease risk
Leveraging Digital Health Solutions to Reduce Learning and Functional Disparities in Children with Cancer PI: Dr. Sunita K. Patel (Beckman Research Institute, City of Hope), R01	Parents of Latino childhood leukemia or lymphoma survivors	School success
Enhancing Health Cost Literacy and Financial Capability among Young Adult Cancer Survivors   PI: Dr. Bridgette H. Thom (Sloan Kettering Institute for Cancer Research), R21	AYA cancer survivors	Health cost literacy and financial capability
Early Identification of Childhood Cancer Survivors at High Risk for Late Onset Cardiomyopathy: An Artificial Intelligence Approach utilizing Electrocardiography PI: Drs. Oguz Akbilgic and Melissa M. Hudson (Wake Forest University Health Science Center), R01	Childhood cancer survivors	Cardiomyopathy
STEP-YA: An Online Self-Management Intervention for Young Adult Cancer Survivors with Insomnia PI: Dr. Christopher John Recklitis (University of Southern California), R21	AYA cancer survivors	Insomnia
FAACTS: Feasibility/Acceptability of Attentional-Control Training in Survivors PI: Dr. Steven Hardy (Children’s National Hospital Research Institute), R21	Brain and leukemia childhood cancer survivors	Attention
An Integrative Approach to Evaluate Neurocognitive Disparities in Latinos Undergoing Treatment for Childhood Leukemia PI: Drs. Kimberly Pauline Raghubar and Philip Lupo (Baylor College of Medicine), R01	Latino childhood leukemia survivors	Neurocognitive performance
Outcomes in AYA Survivors of Pediatric Medulloblastoma   PI: Dr. Tricia Z. King (Georgia State University), R01	Rural childhood and AYA medulloblastoma survivors	Cognitive impairment
Chronic Health Conditions in Survivors of Down Syndrome-Associated Leukemia PI: Drs. Maria Monica Gramatges, Philip Lupo, and Karen R. Rabin (Baylor College of Medicine), R01	Childhood leukemia survivors with Down syndrome	Assessing chronic health conditions
Assessing the effect of virtual navigation interventions to improve health insurance literacy and decrease financial burden: A CCSS randomized trial PI: Drs. Elyse Park and Anne C. Kirchhoff (Massachusetts General Hospital), R01	Childhood cancer survivors	Financial hardship
PreDM: An adaptive, open-label, pilot intervention trial for diabetes prevention PI: Drs. Stephanie Dixon and Kirsten Ness (St. Jude Children’s Research Hospital), R21	Prediabetic childhood cancer survivors	Diabetes prevention
An mHealth Positive Psychology Intervention to Reduce Cancer Burden in Young Adult Cancer Survivors PI: Drs. Carla Berg and Hannah Arem (George Washington University), R21	AYA cancer survivors	Hope
Can risk-reducing medications improve breast cancer prevention in childhood and adolescent cancer survivors? Comparative modeling to inform care PI: Dr. Jennifer Yeh (Boston Children’s Hospital), R01	Childhood and AYA cancer survivors	Modeling risk for subsequent breast cancer

• Collaboration with the Agency for Healthcare Research and Quality (AHRQ): NCI entered into an Inter-Agency Agreement with AHRQ to support its work to implement Section 203 of the STAR Act, focused on identifying best practices in survivorship care, through AHRQ Evidence Reviews on Childhood Cancer Survivorship.
• Ongoing survivorship research efforts: NCI continues its longstanding investment in the Childhood Cancer Survivor Study, which NCI’s Board of Scientific Advisors approved in June 2020 for another 5-year funding period (FY2023-27). The Institute also continues to support a diverse portfolio of survivorship research through investigator-initiated research projects and NCI’s intramural research program.
• NCI support to NCI-designated Cancer Centers: NCI also supported several grant supplemental awards to NCI-designated Cancer Centers, to conduct research to understand and address organizational factors that contribute to disparities in outcomes among childhood cancer survivors.

Additionally, NCI advisory boards, groups, and committees continue to include pediatric oncologists, scientists with pediatric expertise, and patient advocates, as encouraged in Sections 111 and 112 of the STAR Act. For example:

• National Cancer Advisory Board: Dr. Peter Adamson, Sanofi; Dr. Andrea Hayes-Jordan, University of North Carolina Children’s Hospital
• Board of Scientific Advisors: Dr. Mary Beckerle, Huntsman Cancer Institute; Dr. Leslie Robison, St. Jude Children's Research Hospital; Dr. Martine Roussel, St. Jude Children's Research Hospital; Dr. Kevin Shannon, University of California San Francisco
• Clinical and Translational Research Advisory Committee: Dr. Smita Bhatia, University of Alabama at Birmingham; Dr. Anne-Marie Langevin, University of Texas Health Science Center at San Antonio
• Board of Scientific Counselors: Dr. Paul Spearman, Cincinnati Children’s Hospital Medical Center; Dr. Gail E. Tomlinson, University of Texas Health Science Center at San Antonio
• National Council of Research Advocates: Victoria Buenger, Texas A&M University
• Frederick National Laboratory Advisory Committee: Dr. Catherine Bollard, Children’s National Health System; Dr. Nilsa Ramirez Milan, Nationwide Children's Hospital; Dr. Cheryl Willman, Director, University of New Mexico Comprehensive Cancer Center
• National Clinical Trials Network Steering Committees: More than 40 subject matter experts with pediatric expertise serve across three relevant steering committees (Pediatric and Adolescent Solid Tumors, Brain Malignancies, Pediatric Leukemia and Lymphoma), including a patient advocate serving on each committee.
• Study Sections: 120 reviewers with pediatric oncology expertise participated in up to 25 study section meetings in FY 2020.

NCI will also continue to report on childhood cancer research efforts, as directed in Section 121 of the STAR Act, including through the annual NIH Pediatric Research Initiative Report to Congress, as well as the NIH Triennial Report. NCI also reports on activities across its childhood and AYA cancer research portfolio on its website through several pages focused on childhood cancer research and resources for patients and families, and through the Cancer Currents Blog.