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Principal Investigator
Karen M. Mustian
Awardee Organization

University Of Rochester
United States

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

URCC NCORP Research Base

The University of Rochester Cancer Center (URCC) National Cancer Institute Community Oncology Research Program (NCORP) Research Base (RB) has over 35 years of experience conducting cancer control research (CCR) and cancer care delivery research (CCDR). The URCC NCORP RB vision is "to help good people through lousy times when they experience cancer” by reducing cancer- and treatment-related morbidity stemming from toxicities and side effects. Since 2014, 35% (N=2831) of all accrual credits across the entire NCORP network resulted from enrollment of patients and survivors by our Community Affiliates on our 13 active URCC clinical trials. URCC and its Community Affiliates also enrolled 421 caregivers and more than 300 oncologists to our 13 active trials, as well as 1752 patients and survivors to our 29 local pilot studies. URCC successfully enrolled and randomized over 30 individual community oncology practices to cluster randomized trials. Our investigators and staff submitted 8 new concepts/grants, with 18 new concepts/grants currently in development, and 29 active pilot studies. The significant and innovative contribution of URCC research to scientific knowledge and clinical care is evidenced by 1) 197 published manuscripts, 2) 209 presented abstracts, 3) 25 podium presentations at ASCO, 4) 82 outstanding research awards to our investigators, and 5) 2215 investigators, clinicians and staff successfully trained to implement URCC NCORP RB protocols at community sites across the United States. Notable recognition of the significance of research conducted by the URCC RB and its investigators includes: 1) Best of JCO publications for 2017, 2) most cited article in JAMA Oncology for 2017, 3) one of the most significant advances in cancer research and care for 2018, 4) citation of our published research in virtually all existing oncology supportive care treatment guidelines, and 5) leadership by 5 of our RB Executive Committee members in the development of 4 oncology supportive care treatment guidelines. We accomplish our goal of reducing cancer- and treatment-related morbidity by working with cancer patients, survivors, and their caregivers from 592 community oncology practices across the United States to design and conduct CCR and CCDR, including translational outcomes, focused on symptom science. Our research develops and tests novel treatments for toxicities and side effects stemming from cancer and its treatments. We design and conduct phase I-III randomized clinical trials and longitudinal, prospective cohort studies. To meet its responsibilities as a RB and maintain its high level of productivity over the next funding period, the URCC RB will focus its resources and expertise on the following specific aims: Aim 1) to conduct CCR, Aim 2) to conduct CCDR, Aim 3) to conduct translational CCR, and Aim 4) to provide state-of-the-art training in clinical research methods for NCORP investigators and staff. With its proven record of productivity and innovation, the URCC NCORP RB is expertly positioned to continue its pioneering symptom science research in the NCORP Network.

Publications

  • 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
  • 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
  • Chandwani KD, Zhao F, Morrow GR, Deshields TL, Minasian LM, Manola J, Fisch MJ. Lack of Patient-Clinician Concordance in Cancer Patients: Its Relation With Patient Variables. Journal of pain and symptom management. 2017 Jun;53(6):988-998. Epub 2017 Feb 6. PMID: 28185892
  • 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
  • Minasian L, Dimond E, Davis M, Adhikari B, Fagerstrom R, Fabian C, Floyd J, Unger JM, Douglas PS, Mustian KM, Chow EJ, Lipshultz S, Hundley WG, Armenian S, Ky B. The Evolving Design of NIH-Funded Cardio-Oncology Studies to Address Cancer Treatment-Related Cardiovascular Toxicity. JACC. CardioOncology. 2019 Sep;1(1):105-113. Epub 2019 Sep 24. PMID: 32529192
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Carlos RC, Sicks JD, Chiles C, Gansauer L, Kamen CS, Kazak AE, Neuman HB, Unger JM, Weaver KE. Lung Cancer Screening in the National Cancer Institute Community Oncology Research Program: Availability and Service Organization. Journal of the American College of Radiology : JACR. 2019 Apr;16(4 Pt A):427-434. Epub 2019 Feb 26. PMID: 30819455
  • 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
  • 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

Clinical Trials

Study Name Clinical Trial ID
Software Monitoring of Treatment Related Toxicities in Advanced Renal Cell Carcinoma NCT03229083
Yoga, Survivorship Health Education, and Cognitive Behavioral Therapy in Reducing Insomnia in Cancer Survivors NCT02613364
Brief Behavioral Therapy in Improving Sleep Disorders in Patients With Stage I-III Breast Cancer Undergoing Chemotherapy NCT02002533
Low-Dose Ibuprofen in Improving Cognitive Impairment in Patients With Cancer NCT03186638
Prophylactic Topical Agents in Reducing Radiation-Induced Dermatitis in Patients With Non-inflammatory Breast Cancer NCT02556632
Improving Communication in Older Cancer Patients and Their Caregivers NCT02107443
Learning Collaborative Versus Technical Assistance in Delivering a Palliative Care Program to Patients With Advanced Cancer and Their Caregivers NCT04062552
Geriatric Assessment Intervention for Reducing Toxicity in Older Patients With Advanced Cancer NCT02054741
Comparing Brief Behavioral Therapy (BBT-CI) and Healthy Eating Education Learning (HEAL) for Cancer-Related Sleep Problems While Receiving Chemotherapy NCT04829539
Testing the Effects of Exercise on Chemotherapy-Induced Peripheral Neuropathy NCT04888988
Bupropion to Reduce Cancer Related Fatigue in Cancer Survivors NCT03996265
Geriatric Evaluation and Management with Survivorship Health Education (GEMS) for Older Survivors of Cancer NCT05006482
Assessment of Cognitive Function in Breast Cancer and Lymphoma Patients Receiving Chemotherapy NCT01382082
Effects of Transcutaneous Electrical Nerve Stimulation on Chemotherapy-Induced Peripheral Neuropathy NCT04367480
Omega-3 Fatty Acid in Reducing Cancer-Related Fatigue in Breast Cancer Survivors NCT02352779
An Observational Research Study for Cancer Patients on Immune Checkpoint Inhibitors, DiRECT Study NCT05364086
Understanding the Impact of Drug Shortages on Oncology Care Delivery NCT03953027
An Observational Research Study to Uncover Subtypes of Cancer Cachexia NCT06073431
Treatment of Refractory Nausea and Vomiting in Patients With Breast Cancer NCT03367572
High-Dose Vitamin D Supplementation for ADT-Induced Bone Loss in Older Prostate Cancer Patients NCT05838716
Yoga Versus Standard Care for Reducing Fatigue in Hispanic Cancer Survivors (YOCAS©®) NCT05743491