Skip to main content
An official website of the United States government
Government Funding Lapse

Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted.

The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov.

Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Principal Investigator
Glenn J Lesser
Awardee Organization

Wake Forest University Health Sciences
United States

Fiscal Year
2025
Activity Code
UG1
Early Stage Investigator Grants (ESI)
Not Applicable
Project End Date

Wake Forest NCORP Research Base

The overarching goal of the Wake Forest NCORP Cancer Center Research Base (WF NCORP RB) is to improve patient well-being and the quality of cancer care by developing, implementing and successfully completing innovative and feasible Cancer Control and Cancer Care Delivery (CCDR) clinical research studies. For nearly two decades as a CCOP and now NCORP Research Base, Wake Forest has maintained an exclusive focus on Cancer Control and CCDR studies and has emphasized efficient operational processes and extensive interactions with our NCORP Community Site partners. During the first 4 years of the NCORP network, the WF NCORP RB: opened 7 Cancer Control and 3 CCDR studies; enrolled 1,140 participants on WF NCORP RB studies; obtained approval for 5 additional concepts and protocols bringing the total remaining and planned accrual for active and pending trials to over 4,420 participants. Over the next 6 years, we will build on and strengthen this highly successful platform by accomplishing the following Specific Aims: Specific Aim 1: Extend our cancer control clinical research activities in the following areas: cardiovascular complications of cancer therapy; radiation and chemotherapy-induced neurocognitive toxicities; and additional cancer and treatment-related symptoms and related-outcomes prioritized by NCI steering committees and those commonly associated with novel emerging treatment paradigms. Specific Aim 2: Elucidate and intervene upon patient, family, clinician, and organizational factors that influence cancer care delivery, emphasizing survivorship care, informal cancer caregivers and implementation of evidence-based supportive care services. Specific Aim 3: Illuminate biological mechanisms underlying cancer and treatment-related symptoms and toxicities in new and innovative multidisciplinary collaborative studies taking advantage of our growing biobank of blood, urine and salivary fluid specimens. Specific Aim 4: Identify and address factors that influence variations in cancer outcomes via focused studies, integrated aims, and representative recruitment across all Wake Forest NCORP research investigations. Specific Aim 5: Train the next generation of Cancer Control and CCDR researchers through mentoring and involvement of early career faculty, oncology trainees, post-doctoral fellows, and students in WF NCORP activities. Our ongoing and proposed Cancer Control and CCDR studies will continue to improve oncology care by informing best practices for symptom and late effect management as well as efficient, patient-centered, evidence-based cancer care delivery. In the next funding period, the WF NCORP RB will help accelerate the translation of knowledge in cancer control and cancer care delivery through close partnership with community sites and studies designed for future dissemination and implementation.

Publications

  • Braun-Inglis CM, Dressler EV, Myers JS, Benson AB 3rd, Flannery M, Good M, Denicoff A, Berenberg JL, DeTroye AT, O'Brien B, Kottschade L, Omatsu DA, Kittel CA, Nightingale CL, Foust M, Lesser GJ. Defining the Role of the Advanced Practice Provider Within the National Cancer Institute Community Oncology Research Program. JCO oncology practice. 2024 Feb;20(2):239-246. Epub 2024 Jan 4. PMID: 38175992
  • Banegas MP, Nightingale CL, Dressler EV, Cooley ME, Kamen C, Wagner LI, Kittel CA, Flores EJ, Carlos R, Milton A, Park E, Parsons SK, Wood EG, Loh KP, Ramsey S, Landscape Committee, Neuman HB, Nightingale CL, Parsons SK, Obeng-Gyasi S, Cooley ME, Loh KP, Ramsey SD, McDonald AM, Foust M, Braun-Inglis C, Kyono WT, Drescher CW, Wood EG, Dressler EV. Screening and Referral for Health-Related Social Needs and Financial Distress: Current Processes Among National Cancer Institute Community Oncology Research Program Practices. JCO oncology practice. 2025 Mar 13: OP2400902. Epub 2025 Mar 13. PMID: 40080774
  • Makhlin I, Demissei BG, D'Agostino R, Hundley WG, Baleanu-Gogonea C, Wilcox NS, Chen A, Smith AM, O'Connell NS, Januzzi JL, Lesser GJ, Scherrer-Crosbie M, Ibáñez B, Tang WHW, Ky B. Statins Do Not Significantly Affect Oxidative Nitrosative Stress Biomarkers in the PREVENT Randomized Clinical Trial. Clinical cancer research : an official journal of the American Association for Cancer Research. 2024 Jun 3;30(11):2370-2376. PMID: 38573708
  • Cathcart-Rake EJ, Jatoi A, Dressler EV, Kittel C, Weaver KE, Nightingale C, Neuman H, Loh KP, Landscape Committee, Kamen C, Neuman HB, Nightingale CL, Parsons SK, Obeng-Gyasi S, Cooley ME, Loh KP, Ramsey SD, McDonald AM, Foust M, Braun-Inglis C, Kyono WT, Drescher CW, Wood EG, Dressler EV. Sexual Orientation and Gender Identity Data Collection in Cancer Care: A Nationwide Landscape Assessment Update. JCO oncology practice. 2024 Sep;20(9):1272-1279. Epub 2024 May 20. PMID: 38768413
  • Avis NE, Levine BJ, Klepin HD, Mihalko SL, Brubaker PH, Moore T, Ladd AC, Dent SF, Hackney MH, Ky B, Ntim WO, Wagner LI, Weaver KE, Hundley WG, UPBEAT study team. The impact of non- and anthracycline-based chemotherapy on fatigue in breast cancer survivors: results from WF-97415. Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer. 2024 Jul 19;32(8):528. PMID: 39028321
  • McLouth LE, Nightingale CL, Dressler EV, Snavely AC, Hudson MF, Unger JM, Kazak AE, Lee SJC, Edward J, Carlos R, Kamen CS, Neuman HB, Weaver KE. Current Practices for Screening and Addressing Financial Hardship within the NCI Community Oncology Research Program. Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology. 2021 Apr;30(4):669-675. Epub 2020 Dec 21. PMID: 33355237
  • Williams GR, Weaver KE, Lesser GJ, Dressler E, Winkfield KM, Neuman HB, Kazak AE, Carlos R, Gansauer LJ, Kamen CS, Unger JM, Mohile SG, Klepin HD. Capacity to Provide Geriatric Specialty Care for Older Adults in Community Oncology Practices. The oncologist. 2020 Dec;25(12):1032-1038. Epub 2020 Aug 31. PMID: 32820842
  • Dressler EV, Pugh SL, Gunn HJ, Unger JM, Zahrieh DM, Snavely AC. Practical design considerations for cluster randomized controlled trials: lessons learned in community oncology research. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):56-64. PMID: 39989035
  • Izmirlian G, Sirota LA, Berger VW, Kipnis V. The fundamentals of multiplicity adjustment in biostatistics. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):10-13. PMID: 39989036
  • Hu P, Steingrimsson JA, Cole E, Cormack J, Dunn BK, Gatsonis C, Lee C, Li N, Pisano ED, He J, Kramer BS. Design considerations and challenges in the CHinA National CancEr Screening (CHANCES) trial and Tomosynthesis Mammographic Imaging Screening Trial (TMIST). Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):42-48. PMID: 39989037
  • Bandos H, Torres-Saavedra PA, Culakova E, Gunn HJ, Lee MK, Duan F, Cecchini RS, Unger JM, Dueck AC, Steingrimsson JA. Best practices and pragmatic approaches for patient-reported outcomes and quality of life measures in cancer clinical trials. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):14-21. PMID: 39989038
  • Nuño MM, Pugh SL, Ji L, Piao J, Dignam JJ, Steingrimsson JA. On the use of external controls in clinical trials. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):30-34. PMID: 39989040
  • Monge C, Eldridge L, Pearlman PC, Venkatesh V, Tregear M, Loehrer PJ Sr, Galassi A, Gopal S, Ginsburg O. Global perspectives on patient-centered outcomes: advancing patient-centered cancer clinical trials globally. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):35-41. PMID: 39989041
  • Pugh SL, Lee C, Dunn BK, Dignam JJ. The importance of patient-centered research in oncology clinical trials: motivation for the Monograph series. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):1-2. PMID: 39989042
  • Mazza GL, Culakova E, Enserro DM, Dignam JJ, Unger JM. Design and analysis considerations for investigating patient subgroups of interest within cancer clinical trials. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):22-29. PMID: 39989043
  • Garg R, D'Agostino RB Jr, O'Connell N, Lesser GJ, Salloum FN, Hines AL, Meléndez GC, Jordan JH, Ky B, Wagner LI, Sutton AL, Bottinor W, Olson KC, Ladd AC, Hundley WG, UPBEAT Study Team. Hypertension Severity and Declines in Left Ventricular Ejection Fraction Among Women Receiving Adjuvant Chemotherapy for Breast Cancer (WF-97415 UPBEAT). Hypertension (Dallas, Tex. : 1979). 2024 Jun;81(6):1365-1373. Epub 2024 Apr 18. PMID: 38634292
  • Enserro DM, Gunn HJ, Elsaid MI, Duan F, Pugh SL. Challenges to and considerations of designing cancer prevention trials. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):49-55. PMID: 39989045
  • Cathcart-Rake EJ, Zemla T, Jatoi A, Weaver KE, Neuman H, Kazak AE, Carlos R, Gansauer L, Unger JM, Pajewski NM, Kamen C. Acquisition of sexual orientation and gender identity data among NCI Community Oncology Research Program practice groups. Cancer. 2019 Apr 15;125(8):1313-1318. Epub 2018 Dec 18. PMID: 30561776
  • Beauchemin MP, Ji L, Williams AM, Nightingale CL, Dressler EV, Salsman JM, Santacroce SJ, Freyer DR, Roth ME, Parsons SK. Defining Practice Capacity for Cancer Care Delivery to Adolescents and Young Adults in the Community Setting: 2022 Landscape Assessment Results. Journal of adolescent and young adult oncology. 2024 Jun;13(3):557-563. Epub 2024 Feb 23. PMID: 38394227
  • Carlos RC, Sicks JD, Chang GJ, Lyss AP, Stewart TL, Sung L, Weaver KE. Capacity for Cancer Care Delivery Research in National Cancer Institute Community Oncology Research Program Community Practices: Availability of Radiology and Primary Care Research Partners. Journal of the American College of Radiology : JACR. 2017 Dec;14(12):1530-1537. Epub 2017 Oct 19. PMID: 29055605
  • Suddala S, O'Connell N, D'Agostino R Jr, Ladd A, Lucas AR, Jordan JH, Salloum FN, Ky B, Hackney MH, Hundley WG. Reduced Thoracic Aortic Distensibility Upon Breast Cancer Diagnosis (WF-97415 and WF-98213). JACC. CardioOncology. 2023 Mar 7;5(5):704-706. doi: 10.1016/j.jaccao.2022.11.018. eCollection 2023 Oct. PMID: 37969653
  • Sutton AL, O'Connell NS, Lucas AR, Olson KC, Reding KW, Sheppard VB, Ky B, Ruddy KJ, Weaver KE, Hundley WG. Socioeconomic status and left ventricular ejection fraction decline in breast cancer survivors following receipt of doxorubicin (PREVENT WF-98213). Cardio-oncology (London, England). 2025 Feb 5;11(1):11. PMID: 39910652
  • Hundley WG, D'Agostino R Jr, Crotts T, Craver K, Hackney MH, Jordan JH, Ky B, Wagner LI, Herrington DM, Yeboah J, Reding KW, Ladd AC, Rapp SR, Russo S, O'Connell N, Weaver KE, Dressler EV, Ge Y, Melin SA, Gudena V, Lesser GJ. Statins and Left Ventricular Ejection Fraction Following Doxorubicin Treatment. NEJM evidence. 2022 Sep;1. (9). Epub 2022 Aug 18. PMID: 36908314
  • Unger JM, Mazza GL, Elsaid MI, Duan F, Dressler EV, Snavely AC, Enserro DM, Pugh SL. When to adjust for multiplicity in cancer clinical trials. Journal of the National Cancer Institute. Monographs. 2025 Mar 1;2025(68):3-9. PMID: 39989044

Clinical Trials

Study Name Clinical Trial ID
Work Ability in Young Adult Cancer Survivors NCT03148080
Effect of Treatment on Work Experience in Patients With Stage I-III Prostate Cancer NCT03963739
Mobile-Health Delivery of Lifestyle Interventions for Women With Breast Cancer NCT05132296