Principal Investigator

Augusto C.
Ochoa
Awardee Organization

Lsu Health Sciences Center
United States

Fiscal Year
2023
Activity Code
UG1
Early Stage Investigator Grants (ESI)
Not Applicable
Project End Date

Gulf South Minority/Underserved Clinical Trials Network (Gulf South M/U CTN)

Virtual Research Nurse Program (VRN) Addressing Clinical Trials Research Personnel Shortage Most adult cancer patients in the US are diagnosed and treated in community oncology practices. However <5% of patients participate in clinical trials, thus limiting the testing and implementation of scientific advances in “real world” settings. In addition to the well described patient and physician related barriers to clinical trials, the recent changes to the workforce brought about by the COVID-19, including “work from home” initiatives have greatly decreased the number of trained clinical trials personnel. These changes more severely affect community oncology practices in both urban and rural locations where research infrastructure is limited and the ability to adapt to these changes is difficult. The Gulf South NCORP community sites have experienced a severe reduction in accruals due primarily to research personnel shortage. We established a “Virtual Research Nurse” program to provide research infrastructure (regulatory, data management and research nurse) to community sites through virtual means. Using a HIPAA-compliant communication platform we have helped urban and a rural oncology practices select and open clinical trials of interest, screen and identify candidate patients and facilitate their enrollment and follow-up. This approach is distinct from traditional telemedicine, in that telemedicine primarily provides physician services to a distant clinical location, while the VRN program provides the research infrastructure and functions to community oncologists seeking to enroll patients in clinical trials. Our preliminary data shows that a centrally located VRN efficiently screens the community clinics, identifies potential candidates for clinical trials and with the community oncologist enrolls patients on clinical trials. The VRN also provides long-term management of the patient. Furthermore, in collaboration with Medidata Solutions we will further streamline the implementation of VRN by ensuring that data collected is seamlessly transferred to the RAVE system, thus minimizing the error-prone process transcribing data by hand. We believe that the VRN will significantly facilitate the participation of community oncology practices and patients in clinical trials and help address the severe shortage of trained clinical trials personnel and research infrastructure. We propose to: Specific Aim 1a. Complete the development of the VRN prototype in collaboration with Medidata Solutions to have a fully functional platform that can be used in NCORP sites. This will be a Proof Of Concept (POC) program designed to demonstrate the use of technology, training, and clinical trial expertise to support these clinics and patients. 1b. Expand the number of sites to test the integrated VRN program to 4 sites (2 urban and 2 rural) to determine and compare the effect of implementing a VRN program at community oncology practices in urban and rural locations. Aim 2: Develop standard operating procedures (SOPs) for the implementation of the VRN program at other clinical centers.

Publications

  • Messing EM, Tangen CM, Lerner SP, Sahasrabudhe DM, Koppie TM, Wood DP Jr, Mack PC, Svatek RS, Evans CP, Hafez KS, Culkin DJ, Brand TC, Karsh LI, Holzbeierlein JM, Wilson SS, Wu G, Plets M, Vogelzang NJ, Thompson IM Jr. Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non-Muscle-Invasive Bladder Cancer on Tumor Recurrence: SWOG S0337 Randomized Clinical Trial. JAMA. 2018 May 8;319(18):1880-1888. PMID: 29801011
  • Borghaei H, Redman MW, Kelly K, Waqar SN, Robert F, Kiefer GJ, Stella PJ, Minichiello K, Gandara DR, Herbst RS, Papadimitrakopoulou VA. SWOG S1400A (NCT02154490): A Phase II Study of Durvalumab for Patients With Previously Treated Stage IV or Recurrent Squamous Cell Lung Cancer (Lung-MAP Sub-study). Clinical lung cancer. 2021 May;22(3):178-186. Epub 2020 Nov 10. PMID: 33358401
  • Yao JC, Guthrie KA, Moran C, Strosberg JR, Kulke MH, Chan JA, LoConte N, McWilliams RR, Wolin EM, Mattar B, McDonough S, Chen H, Blanke CD, Hochster HS. Phase III Prospective Randomized Comparison Trial of Depot Octreotide Plus Interferon Alfa-2b Versus Depot Octreotide Plus Bevacizumab in Patients With Advanced Carcinoid Tumors: SWOG S0518. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2017 May 20;35(15):1695-1703. Epub 2017 Apr 6. PMID: 28384065
  • Henry NL, Unger JM, Schott AF, Fehrenbacher L, Flynn PJ, Prow DM, Sharer CW, Burton GV, Kuzma CS, Moseley A, Lew DL, Fisch MJ, Moinpour CM, Hershman DL, Wade JL 3rd. Randomized, Multicenter, Placebo-Controlled Clinical Trial of Duloxetine Versus Placebo for Aromatase Inhibitor-Associated Arthralgias in Early-Stage Breast Cancer: SWOG S1202. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2018 Feb 1;36(4):326-332. Epub 2017 Nov 14. PMID: 29136387
  • Durie BGM, Hoering A, Sexton R, Abidi MH, Epstein J, Rajkumar SV, Dispenzieri A, Kahanic SP, Thakuri MC, Reu FJ, Reynolds CM, Orlowski RZ, Barlogie B. Longer term follow-up of the randomized phase III trial SWOG S0777: bortezomib, lenalidomide and dexamethasone vs. lenalidomide and dexamethasone in patients (Pts) with previously untreated multiple myeloma without an intent for immediate autologous stem cell transplant (ASCT). Blood cancer journal. 2020 May 11;10(5):53. PMID: 32393732
  • Puvvada SD, Stiff PJ, Leblanc M, Cook JR, Couban S, Leonard JP, Kahl B, Marcellus D, Shea TC, Winter JN, Li H, Rimsza LM, Friedberg JW, Smith SM. Outcomes of MYC-associated lymphomas after R-CHOP with and without consolidative autologous stem cell transplant: subset analysis of randomized trial intergroup SWOG S9704. British journal of haematology. 2016 Sep;174(5):686-91. Epub 2016 Apr 13. PMID: 27072903
  • Tilburt JC, Zahrieh D, Pacyna JE, Petereit DG, Kaur JS, Rapkin BD, Grubb RL 3rd, Chang GJ, Morris MJ, Kovac EZ, Babaian KN, Sloan JA, Basch EM, Peil ES, Dueck AC, Novotny PJ, Paskett ED, Buckner JC, Joyce DD, Montori VM, Frosch DL, Volk RJ, Kim SP. Decision aids for localized prostate cancer in diverse minority men: Primary outcome results from a multicenter cancer care delivery trial (Alliance A191402CD). Cancer. 2022 Mar 15;128(6):1242-1251. Epub 2021 Dec 10. PMID: 34890060
  • Advani AS, Li H, Michaelis LC, Medeiros BC, Liedtke M, List AF, O'Dwyer K, Othus M, Erba HP, Appelbaum FR. Report of the relapsed/refractory cohort of SWOG S0919: A phase 2 study of idarubicin and cytarabine in combination with pravastatin for acute myelogenous leukemia (AML). Leukemia research. 2018 Apr;67:17-20. Epub 2018 Jan 31. PMID: 29407182
  • Chiorean EG, Guthrie KA, Philip PA, Swisher EM, Jalikis F, Pishvaian MJ, Berlin J, Noel MS, Suga JM, Garrido-Laguna I, Cardin DB, Radke MR, Duong M, Bellasea S, Lowy AM, Hochster HS. Randomized Phase II Study of PARP Inhibitor ABT-888 (Veliparib) with Modified FOLFIRI versus FOLFIRI as Second-line Treatment of Metastatic Pancreatic Cancer: SWOG S1513. Clinical cancer research : an official journal of the American Association for Cancer Research. 2021 Dec 1;27(23):6314-6322. Epub 2021 Sep 27. PMID: 34580114
  • Herbst RS, Redman MW, Kim ES, Semrad TJ, Bazhenova L, Masters G, Oettel K, Guaglianone P, Reynolds C, Karnad A, Arnold SM, Varella-Garcia M, Moon J, Mack PC, Blanke CD, Hirsch FR, Kelly K, Gandara DR. Cetuximab plus carboplatin and paclitaxel with or without bevacizumab versus carboplatin and paclitaxel with or without bevacizumab in advanced NSCLC (SWOG S0819): a randomised, phase 3 study. The Lancet. Oncology. 2018 Jan;19(1):101-114. Epub 2017 Nov 20. PMID: 29169877
  • Puvvada SD, Li H, Rimsza LM, Bernstein SH, Fisher RI, LeBlanc M, Schmelz M, Glinsmann-Gibson B, Miller TP, Maddox AM, Friedberg JW, Smith SM, Persky DO. A phase II study of belinostat (PXD101) in relapsed and refractory aggressive B-cell lymphomas: SWOG S0520. Leukemia & lymphoma. 2016 Oct;57(10):2359-69. Epub 2016 Jan 12. PMID: 26758422
  • Flaig TW, Plets M, Hussain MHA, Agarwal N, Mitsiades N, Deshpande HA, Vaishampayan UN, Thompson IM Jr. Abiraterone Acetate for Metastatic Prostate Cancer in Patients With Suboptimal Biochemical Response to Hormone Induction. JAMA oncology. 2017 Nov 9;3(11):e170231. Epub 2017 Nov 9. PMID: 28358937
  • Flaig TW, Tangen CM, Daneshmand S, Alva A, Lerner SP, Lucia MS, McConkey DJ, Theodorescu D, Goldkorn A, Milowsky MI, Bangs R, MacVicar GR, Bastos BR, Fowles JS, Gustafson DL, Plets M, Thompson IM Jr. A Randomized Phase II Study of Coexpression Extrapolation (COXEN) with Neoadjuvant Chemotherapy for Bladder Cancer (SWOG S1314; NCT02177695). Clinical cancer research : an official journal of the American Association for Cancer Research. 2021 May 1;27(9):2435-2441. Epub 2021 Feb 10. PMID: 33568346
  • Davis TC, Arnold CL, Mills G, Lesser GJ, Brown WM, Schulz R, Weaver KE, Pawloski PA. Assessment of Oral Chemotherapy Nonadherence in Chronic Myeloid Leukemia Patients Using Brief Measures in Community Cancer Clinics: A Pilot Study. International journal of environmental research and public health. 2021 Oct 21;18. (21). PMID: 34769563
  • Danilov AV, Li H, Press OW, Shapira I, Swinnen LJ, Noy A, Reid E, Smith SM, Friedberg JW. Feasibility of interim positron emission tomography (PET)-adapted therapy in HIV-positive patients with advanced Hodgkin lymphoma (HL): a sub-analysis of SWOG S0816 Phase 2 trial. Leukemia & lymphoma. 2017 Feb;58(2):461-465. Epub 2016 Jul 7. PMID: 27386786
  • Kates M, Chu X, Hahn N, Pietzak E, Smith A, Shevrin DH, Crispen P, Williams SB, Daneshmand S, Packiam VT, Porten S, Westerman ME, Wagner LI, Carducci M. Background and Update for ECOG-ACRIN EA8212: A Randomized Phase 3 Trial of Intravesical Bacillus Calmette-Guérin (BCG) Versus Intravesical Docetaxel and Gemcitabine Treatment in BCG-naïve High-grade Non-muscle-invasive Bladder Cancer (BRIDGE). European urology focus. 2023 Jul;9(4):561-563. Epub 2023 Jul 6. PMID: 37422371
  • Moinpour CM, Unger JM, Ganz PA, Kornblith AB, Gaynor ER, Bowers MA, Gatti GS, Kaminski MS, Erba HP, Wang T, Yoon J, Press OW, Fisher RI. Seven-year follow-up for energy/vitality outcomes in early stage Hodgkin's disease patients treated with subtotal lymphoid irradiation versus chemotherapy plus radiation: SWOG S9133 and its QOL companion study, S9208. Journal of cancer survivorship : research and practice. 2017 Feb;11(1):32-40. Epub 2016 Jul 12. PMID: 27405732
  • Owonikoko TK, Redman MW, Byers LA, Hirsch FR, Mack PC, Schwartz LH, Bradley JD, Stinchcombe TE, Leighl NB, Al Baghdadi T, Lara P Jr, Miao J, Kelly K, Ramalingam SS, Herbst RS, Papadimitrakopoulou V, Gandara DR. Phase 2 Study of Talazoparib in Patients With Homologous Recombination Repair-Deficient Squamous Cell Lung Cancer: Lung-MAP Substudy S1400G. Clinical lung cancer. 2021 May;22(3):187-194.e1. Epub 2021 Jan 10. PMID: 33583720
  • Heinrich MC, Rankin C, Blanke CD, Demetri GD, Borden EC, Ryan CW, von Mehren M, Blackstein ME, Priebat DA, Tap WD, Maki RG, Corless CL, Fletcher JA, Owzar K, Crowley JJ, Benjamin RS, Baker LH. Correlation of Long-term Results of Imatinib in Advanced Gastrointestinal Stromal Tumors With Next-Generation Sequencing Results: Analysis of Phase 3 SWOG Intergroup Trial S0033. JAMA oncology. 2017 Jul 1;3(7):944-952. PMID: 28196207
  • Durie BGM, Hoering A, Abidi MH, Rajkumar SV, Epstein J, Kahanic SP, Thakuri M, Reu F, Reynolds CM, Sexton R, Orlowski RZ, Barlogie B, Dispenzieri A. Bortezomib with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with newly diagnosed myeloma without intent for immediate autologous stem-cell transplant (SWOG S0777): a randomised, open-label, phase 3 trial. Lancet (London, England). 2017 Feb 4;389(10068):519-527. Epub 2016 Dec 23. PMID: 28017406
  • Krop IE, Jegede OA, Grilley-Olson JE, Lauring JD, Mitchell EP, Zwiebel JA, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Kono SA, Ford JM, Garcia AA, Sui XD, Siegel RD, Slomovitz BM, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II Study of Taselisib in PIK3CA-Mutated Solid Tumors Other Than Breast and Squamous Lung Cancer: Results From the NCI-MATCH ECOG-ACRIN Trial (EAY131) Subprotocol I. JCO precision oncology. 2022 Feb;6:e2100424. PMID: 35138919
  • Press OW, Li H, Schöder H, Straus DJ, Moskowitz CH, LeBlanc M, Rimsza LM, Bartlett NL, Evens AM, Mittra ES, LaCasce AS, Sweetenham JW, Barr PM, Fanale MA, Knopp MV, Noy A, Hsi ED, Cook JR, Lechowicz MJ, Gascoyne RD, Leonard JP, Kahl BS, Cheson BD, Fisher RI, Friedberg JW. US Intergroup Trial of Response-Adapted Therapy for Stage III to IV Hodgkin Lymphoma Using Early Interim Fluorodeoxyglucose-Positron Emission Tomography Imaging: Southwest Oncology Group S0816. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2016 Jun 10;34(17):2020-7. Epub 2016 Apr 11. PMID: 27069074
  • Kopetz S, Guthrie KA, Morris VK, Lenz HJ, Magliocco AM, Maru D, Yan Y, Lanman R, Manyam G, Hong DS, Sorokin A, Atreya CE, Diaz LA, Allegra C, Raghav KP, Wang SE, Lieu CH, McDonough SL, Philip PA, Hochster HS. Randomized Trial of Irinotecan and Cetuximab With or Without Vemurafenib in BRAF-Mutant Metastatic Colorectal Cancer (SWOG S1406). Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021 Feb 1;39(4):285-294. Epub 2020 Dec 23. PMID: 33356422
  • Wu XC, Yu Q, Yi Y, Maniscalco LS, Hsieh MC, Gruber D, Mendoza L, Subbiah S, Sokol T, Shrestha P, Chen VW, Mederos ET, Ochoa A. Effect of chronic disease on racial difference in COVID-19-associated hospitalization among cancer patients. Journal of the National Cancer Institute. 2023 Oct 9;115(10):1204-1212. PMID: 37697664