Abstract
Background: Patient access to clinical trials has been identified as a key measure for delivery of quality cancer care. Effective recruitment and retention strategies remain an issue. Furthermore, clinical trial participants historically lack diversity. This project focused on advanced practice provider (APP) mentorship and paired clinical research support to enhance minority accrual to supportive care trials in Hawai‘i. Methods: Over a 1-year period, a formal mentorship program for six participating APPs and three clinical research coordinators (CRCs) in the Hawai‘i Minority/Underserved National Cancer Institute Community Oncology Research Program (HI M/U NCORP) was implemented. An introductory meeting kicked off the project. The APP and CRC teams then met weekly for targeted screening and accrual to supportive care trials. Monthly meetings between the mentor and teams were conducted to discuss barriers, best practices, and problem solve issues.Results: 26 unique accruals were obtained by the APP and CRC teams over the project period while increasing minority accrual. All six APPs are now actively enrolling to trials. Four of the six participating APPs are now reviewing protocols for the HI M/U NCORP for feasibility and scientific merit. Eight of the nine participating APPs and CRCs found the intervention to be acceptable and feasible. Conclusions: Mentorship of APP and CRC teams can be a successful strategy in increasing accrual and participation of APPs in clinical trial activities. Measuring minority accrual based on this strategy is more complex and dependent on the APP location, clinical trial portfolio, APP patient panel and clinical interest, as well as the expertise of the APP.
References
American Cancer Society Cancer Action Network. (2019). Barriers to patient enrollment in therapeutic clinical trials for cancer. https://www.fightcancer.org/policy-resources/clinical-trial-barriers
American Society of Clinical Oncology. (2017). The state of cancer care in America, 2017: A report by the American Society of Clinical Oncology. Journal of Oncology Practice. https://www.ncbi.nlm.nih.gov/pubmed/28326862
Braun-Inglis, C., Boehmer, M. L., Zitella, J. L., Hoffner, B., Shvetsov, Y., Berenberg, J. L., Oyer, R. A., & Benson III, A. B. (2022). Role of oncology advanced practitioners to enhance clinical research. Journal of the Advanced Practitioner in Oncology, 13(2), 107–119. https://doi.org/10.6004/jadpro.2022.13.2.2
Braun-Inglis, C. M., Dressler, E. V., Myers, J. S., Benson, A. B., Flannery, M., Good, M., Denicoff, A., Berenberg, J. L., DeTroye, A. T., O’Brien, B., Kottschade, L., Omatsu, D. A., Kittel, C. A., Nightingale, C. L., Foust, M., & Lesser, G. J. (2024). Defining the role of the advanced practice provider within the National Cancer Institute Community Oncology Research Program. JCO Oncology Practice, 20(2), 239–246. https://doi.org/10.1200/op.23.00501
Bruinooge, S. S., Pickard, T. A., Vogel, W., Hanley, A., Schenkel, C., Garrett-Mayer, E., Tetzlaff, E., Rosenzweig, M., Hylton, H., Westin, S. N., Smith, N., Lynch, C., Kosty, M. P., & Williams, S. F. (2018). Understanding the role of advanced practice providers in oncology in the United States. Journal of the Advanced Practitioner in Oncology, 9(6). https://doi.org/10.6004/jadpro.2018.9.6.2
Coombs, L., Noonan, K., Barber, F. D., Mackey, H., Peterson, M., Turner, T., & LeFebvre, K. (2020). Oncology nurse practitioner competencies: Defining best practices in the oncology setting. Clinical Journal of Oncology Nursing, 24(3), 296–304. https://doi.org/10.1188/20.cjon.296-304
Coombs, L. A., Max, W., Kolevska, T., Tonner, C., & Stephens, C. (2019). Nurse practitioners and physician assistants: An underestimated workforce for older adults with cancer. Journal of the American Geriatrics Society. https://www.ncbi.nlm.nih.gov/pubmed/31059140
Good, M. (2020). NCI DCP & DCCPS NCORP guidelines: Advanced practice provider roles in DCP trials & DCCPS studies. Presented at NCORP Administrator Webinar, September 16, 2020
Hallquist Viale, P. (2016). Participation in cancer clinical trials: Researching the causes of low accrual. Journal of the Advanced Practitioner in Oncology, 7(2). https://doi.org/10.6004/jadpro.2016.7.2.1
Huang, G. D., Bull, J., McKee, K. J., Mahon, E., Harper, B., & Roberts, J. N. (2018). Clinical trials recruitment planning: A proposed framework from the Clinical Trials Transformation Initiative. Contemporary Clinical Trials, 66, 74–79. https://doi.org/10.1016/j.cct.2018.01.003
Hylton, H. M., & Smith, G. L. (2017). Collaborating with advanced practice providers: Impact and opportunity. American Society of Clinical Oncology Educational Book, (37), 1–7. https://doi.org/10.1200/edbk_175654
Kim, D. J., Otap, D., Ruel, N., Gupta, N., Khan, N., & Dorff, T. (2020). NCI–clinical trial accrual in a community network affiliated with a designated cancer center. MDPI. https://www.mdpi.com/2077-0383/9/6/1970/htm
McCaskill-Stevens, W., McKinney, M. M., Whitman, C. G., & Minasian, L. M. (2005). Increasing minority participation in cancer clinical trials: The Minority-Based Community Clinical Oncology Program experience. Journal of Clinical Oncology, 23(22), 5247–5254. https://doi.org/10.1200/jco.2005.22.236
Michaels, M., Blakeney, N., Langford, A. T., & Ford, M. E. (2014). Five principles for effective cancer clinical trial education within the community setting. Journal of Cancer Education, 30(1), 197–203. https://doi.org/10.1007/s13187-014-0699-6
National Cancer Institute. (2021). Investigator’s handbook. Cancer Therapy Evaluation Program (CTEP). https://ctep.cancer.gov/investigatorResources/investigators_handbook.htm
National Cancer Institute Community Oncology Research Program (NCORP). (n.d.). https://ncorp.cancer.gov/
Oyer, R. A., Hurley, P., Boehmer, L., Bruinooge, S. S., Levit, K., Barrett, N., Benson, A., Bernick, L. A., Byatt, L., Charlot, M., Crews, J., DeLeon, K., Fashoyin-Aje, L., Garrett-Mayer, E., Gralow, J. R., Green, S., Guerra, C. E., Hamroun, L., Hardy, C. M.,…Pierce, L. J. (2022). Increasing racial and ethnic diversity in cancer clinical trials: An American Society of Clinical Oncology and Association of Community Cancer Centers joint research statement. Journal of Clinical Oncology, 40(19), 2163–2171. https://doi.org/10.1200/jco.22.00754
Pickard, T., Hylton, H., & Mitchell, S. A. (2023). Science of teams and provision of team-based care in oncology: An advanced practice provider perspective. JCO Oncology Practice, 19(1), 16–18. https://doi.org/10.1200/op.22.00633
Rimel, B. J. (2016). Clinical trial accrual: Obstacles and opportunities. Frontiers in Oncology, 6. https://doi.org/10.3389/fonc.2016.00103
Unger, J. M., & Fleury, M. (2021). Nationally representative estimates of the participation of cancer patients in clinical research studies according to the Commission on Cancer. Journal of Clinical Oncology, 39(28_suppl), 74–74. https://doi.org/10.1200/jco.2020.39.28_suppl.74
Unger, J. M., Hershman, D. L., Till, C., Minasian, L. M., Osarogiagbon, R. U., Fleury, M., & Vaidya, R. (2020). “When offered to participate”: A systematic review and meta-analysis of patient agreement to participate in cancer clinical trials. Journal of Clinical Oncology, 38(29_suppl), 92–92. https://doi.org/10.1200/jco.2020.38.29_suppl.92
Unger, J. M., Vaidya, R., Hershman, D. L., Minasian, L. M., & Fleury, M. E. (2019). Systematic review and meta-analysis of the magnitude of structural, clinical, and physician and patient barriers to cancer clinical trial participation. JNCI: Journal of the National Cancer Institute, 111(3), 245–255. https://doi.org/10.1093/jnci/djy221
University of Hawaii Cancer Center. (n.d.). University of Hawaii Cancer Center: Accelerating cures through cancer research in Hawaii. https://www.uhcancercenter.org/