Clinical trial accrual is vital to advancing care. A single study elucidated demographic data correlating with glioma patients’ clinical trial enrollment. However, it did not investigate the underlying decision-making process for non-participation. In this study, we seek to understand this key aspect of patient accrual. All notes for glioma patients seen by a single neuro-oncologist from July 2010 to May 2017 were examined for mention of clinical trial offerings. When a trial was declined, the patient’s reasoning was recorded along with the following: diagnosis, KPS, extent of resection, age, gender, race, marital status, income group, religion, trial offered at initial visit versus subsequent, and distance from trial site. Of 279 consecutive glioma patients, 88 were eligible for and offered a clinical trial. Fifty-seven accepted (65%), and 31 (35%) declined participation (Fig. 1). Of those offered a clinical trial, patients with glioblastoma (GBM) were significantly more likely to accept (44 out of 57 (77%) vs. 13 out of 57 (23%), p =0.03). After we adjusted for gender and travel distance, GBM was the only significant predictor of clinical trial acceptance, with an odds ratio of 3.18 (95% CI 1.17, 8.61, p =0.02). Reasons cited for non-participation included: travel distance (39%), lack of interest (39%), visit frequency (16%), and fear of randomization (6%). This study clarified for the first time individual glioma patient rationale for non-participation and potential areas for improving enrollment. Allowing off-site treatment centers or telemedicine visits may entice rural patients to participate. Visit frequency should be carefully considered and minimized whenever possible. Further prospective study of rationale for non-participation may improve enrollment over time.
This is a preview of subscription content, log in to check access.
Buy single article
Instant access to the full article PDF.
Price includes VAT for USA
Subscribe to journal
Immediate online access to all issues from 2019. Subscription will auto renew annually.
This is the net price. Taxes to be calculated in checkout.
Stensland KD, McBride RB, Latif A, Wisnivesky J, Hendricks R, Roper N, et al. Adult cancer clinical trials that fail to complete: an epidemic? JNCI: J Natl Cancer Inst. 2014;106(9).
Korn EL, Freidlin B, Mooney M, Abrams JS. Accrual experience of National Cancer Institute Cooperative Group phase III trials activated from 2000 to 2007. J Clin Oncol. 2010;28(35):5197.
Schroen AT, Petroni GR, Wang H, Thielen MJ, Gray R, Benedetti J, et al. Achieving sufficient accrual to address the primary endpoint in phase III clinical trials from US Cooperative Oncology Groups. Clin Cancer Res. 2011.
Madsen H, Hellwinkel JE, Graner MW. Clinical trials in glioblastoma—designs and challenges. Molecular Considerations and Evolving Surgical Management Issues in the Treatment of Patients with a Brain Tumor. InTech; 2015.
Kim ES, Bruinooge SS, Roberts S, Ison G, Lin NU, Gore L, et al. Broadening eligibility criteria to make clinical trials more representative: American Society of Clinical Oncology and Friends of Cancer Research Joint Research Statement. J Clin Oncol. 2017;35(33):3737–44.
Lin NU, Prowell T, Tan AR, Kozak M, Rosen O, Amiri-Kordestani L, et al. Modernizing clinical trial eligibility criteria: recommendations of the American Society of Clinical Oncology–Friends of Cancer Research Brain Metastases Working Group. J Clin Oncol. 2017;35(33):3760–73. https://doi.org/10.1200/jco.2017.74.0761.
Howerton MW, Gibbons MC, Baffi CR, Gary TL, Lai GY, Bolen S, et al. Provider roles in the recruitment of underrepresented populations to cancer clinical trials. Cancer. 2007;109(3):465–76.
Benson A 3rd, Pregler JP, Bean JA, Rademaker AW, Eshler B, Anderson K. Oncologists’ reluctance to accrue patients onto clinical trials: an Illinois Cancer Center study. J Clin Oncol. 1991;9(11):2067–75.
Ellington L, Wahab S, Sahami Martin S, Field R, Mooney KH. Factors that influence Spanish-and English-speaking participants’ decision to enroll in cancer randomized clinical trials. Psycho-Oncology. 2006;15(4):273–84.
Hutchins LF, Unger JM, Crowley JJ, Coltman CA, Albain KS. Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med. 1999;341(27):2061–7. https://doi.org/10.1056/nejm199912303412706.
Sateren WB, Trimble EL, Abrams J, Brawley O, Breen N, Ford L, et al. How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol. 2002;20(8):2109–17.
Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. Jama. 2004;291(22):2720–6.
Chang SM, Barker FG, Schmidt MH, Sloan AE, Kasper R, Phillips L, et al. Clinical trial participation among patients enrolled in the Glioma Outcomes Project. Cancer. 2002;94(10):2681–7.
Ford JG, Howerton MW, Lai GY, Gary TL, Bolen S, Gibbons MC, et al. Barriers to recruiting underrepresented populations to cancer clinical trials: a systematic review. Cancer. 2008;112(2):228–42.
Unger JM, Hershman DL, Albain KS, Moinpour CM, Petersen JA, Burg K, et al. Patient income level and cancer clinical trial participation. J Clin Oncol. 2013;31(5):536.
Jr PNL, Higdon R, Lim N, Kwan K, Tanaka M, Lau DHM, et al. Prospective evaluation of cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol. 2001;19(6):1728–33. https://doi.org/10.1200/jco.2001.19.6.1728.
Tejeda HA, Green SB, Trimble EL, Ford L, High JL, Ungerleider RS, et al. Representation of African-Americans, Hispanics, and whites in national cancer institute cancer treatment trials. JNCI. 1996;88(12):812–6. https://doi.org/10.1093/jnci/88.12.812.
Gotay CC. Accrual to cancer clinical trials: directions from the research literature. Soc Sci Med. 1991;33(5):569–77.
Gilbert MR, Dignam JJ, Armstrong TS, Wefel JS, Blumenthal DT, Vogelbaum MA, et al. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014;370(8):699–708.
Stupp R, Taillibert S, Kanner AA, Kesari S, Steinberg DM, Toms SA, et al. Maintenance therapy with tumor-treating fields plus temozolomide vs temozolomide alone for glioblastoma: a randomized clinical trial. JAMA. 2015;314(23):2535–43.
van den Bent MJ, Smits M, Kros JM, Chang SM. Diffuse infiltrating oligodendroglioma and astrocytoma. J Clin Oncol. 2017;35(21):2394–401.
Figarella-Branger D, Bouvier C, de Paula AM, Mokhtari K, Colin C, Loundou A, et al. Molecular genetics of adult grade II gliomas: towards a comprehensive tumor classification system. J Neuro-oncol. 2012;110(2):205–13.
Kahneman D, Tversky A. Prospect theory: an analysis of decision under risk. Econometrica. 1979;47(2):263–91. https://doi.org/10.2307/1914185.
Enzinger AC, Zhang B, Weeks JC, Prigerson HG. Clinical trial participation as part of end-of-life cancer care: associations with medical care and quality of life near death. J Pain Symptom Manag. 2014;47(6):1078–90. https://doi.org/10.1016/j.jpainsymman.2013.07.004.
Ostrom QT, Gittleman H, Liao P, Vecchione-Koval T, Wolinsky Y, Kruchko C, et al. CBTRUS statistical report: primary brain and other central nervous system tumors diagnosed in the United States in 2010–2014. Neuro-Oncology. 2017;19(suppl_5):v1–88. https://doi.org/10.1093/neuonc/nox158.
Mattson ME, Curb JD, McArdle R. Participation in a clinical trial: the patients’ point of view. Controll Clin Trials. 1985;6(2):156–67.
Verheggen FW, Nieman F, Jonkers R. Determinants of patient participation in clinical studies requiring informed consent: why patients enter a clinical trial. Patient Educ Couns. 1998;35(2):111–25.
Ganz PA. Clinical trials. Concerns of the patient and the public. Cancer. 1990;65(S10):2394–9.
Census Bureau US. R1901-MEDIAN HOUSEHOLD INCOME (IN 2016 INFLATION-ADJUSTED DOLLARS)-United States—States; and Puerto Rico United States Census Bureau American FactFinder; 2016.
The authors wish to acknowledge the support of the Fred & Pamela Buffett Cancer Center Biostatistics Shared Resource, supported by the National Cancer Institute under Award Number P30 CA036727.
This publication was supported by the Fred & Pamela Buffett Cancer Center Support Grant from the National Cancer Institute under Award Number P30 CA036727.
Conflict of interest
The authors declare that they have no conflict of interest.
Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
This abstract was presented at the Society of Neuro-Oncology Annual Scientific Meeting in New Orleans, November, 2018. https://academic.oup.com/neuro-oncology/article/20/suppl_6/NP/5154662
About this article
Cite this article
Jirka, G.W., Bisselou, K.S.M., Smith, L.M. et al. Evaluating the decisions of glioma patients regarding clinical trial participation: a retrospective single provider review. Med Oncol 36, 34 (2019). https://doi.org/10.1007/s12032-019-1259-z
- Clinical trial
- Evaluating decisions