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Evaluating the decisions of glioma patients regarding clinical trial participation: a retrospective single provider review

Abstract

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.

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Fig. 1

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Acknowledgements

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.

Funding

This publication was supported by the Fred & Pamela Buffett Cancer Center Support Grant from the National Cancer Institute under Award Number P30 CA036727.

Author information

Correspondence to Nicole Shonka.

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The authors declare that they have no conflict of interest.

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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

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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

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Keywords

  • Glioma
  • Clinical trial
  • Accrual
  • Evaluating decisions
  • Non-participation