Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321

Viswatej Avutu; Aaron R. Weiss; Damon R. Reed; Safia K. Ahmed; Wendy A. Allen-Rhoades; Yen Lin E. Chen; Lara E. Davis; Bree R. Eaton; Douglas S. Hawkins; Danny J. Indelicato; Shreyaskumar R. Patel; R. Lor Randall; Denise K. Reinke; Richard F. Riedel; Thomas J. Scharschmidt; Katherine A. Thornton; Dian Wang; Katherine A. Janeway; Lisa M. Kopp

doi:10.1089/jayao.2021.0103

Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321

Viswatej Avutu, Aaron R. Weiss, Damon R. Reed, Safia K. Ahmed, Wendy A. Allen-Rhoades, Yen Lin E. Chen, Lara E. Davis, Bree R. Eaton, Douglas S. Hawkins, Danny J. Indelicato, Shreyaskumar R. Patel, R. Lor Randall, Denise K. Reinke, Richard F. Riedel, Thomas J. Scharschmidt, Katherine A. Thornton, Dian Wang, Katherine A. Janeway, Lisa M. Kopp

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5 Scopus citations

Abstract

ARST1321, a trial of patients with advanced soft tissue sarcoma, was the first National Clinical Trials Network study codeveloped by pediatric and adult consortia with two treatment cohorts. We report on the findings of a survey to identify barriers to enrolling adolescent and young adult patients (15-39 years) onto the nonchemotherapy arm. The survey response rate was 31% with a 70% completion rate. Common identified reasons for low accrual in order of decreasing frequency included insufficient funding, lack of study awareness or interest, competing trials, toxicity concerns, philosophical differences in the therapy backbone, and regulatory and infrastructure barriers. Clinical Trials.gov ID: NCT02180867.

Original language	English (US)
Pages (from-to)	328-332
Number of pages	5
Journal	Journal of Adolescent and Young Adult Oncology
Volume	11
Issue number	3
DOIs	https://doi.org/10.1089/jayao.2021.0103
State	Published - Jun 1 2022

Keywords

NCTN
clinical trials
cooperative groups
enrollment barriers
survey

ASJC Scopus subject areas

Pediatrics, Perinatology, and Child Health
Oncology

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10.1089/jayao.2021.0103

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Avutu, V., Weiss, A. R., Reed, D. R., Ahmed, S. K., Allen-Rhoades, W. A., Chen, Y. L. E., Davis, L. E., Eaton, B. R., Hawkins, D. S., Indelicato, D. J., Patel, S. R., Randall, R. L., Reinke, D. K., Riedel, R. F., Scharschmidt, T. J., Thornton, K. A., Wang, D., Janeway, K. A., & Kopp, L. M. (2022). Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321. Journal of Adolescent and Young Adult Oncology, 11(3), 328-332. https://doi.org/10.1089/jayao.2021.0103

Avutu, V, Weiss, AR, Reed, DR, Ahmed, SK, Allen-Rhoades, WA, Chen, YLE, Davis, LE, Eaton, BR, Hawkins, DS, Indelicato, DJ, Patel, SR, Randall, RL, Reinke, DK, Riedel, RF, Scharschmidt, TJ, Thornton, KA, Wang, D, Janeway, KA & Kopp, LM 2022, 'Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321', Journal of Adolescent and Young Adult Oncology, vol. 11, no. 3, pp. 328-332. https://doi.org/10.1089/jayao.2021.0103

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abstract = "ARST1321, a trial of patients with advanced soft tissue sarcoma, was the first National Clinical Trials Network study codeveloped by pediatric and adult consortia with two treatment cohorts. We report on the findings of a survey to identify barriers to enrolling adolescent and young adult patients (15-39 years) onto the nonchemotherapy arm. The survey response rate was 31% with a 70% completion rate. Common identified reasons for low accrual in order of decreasing frequency included insufficient funding, lack of study awareness or interest, competing trials, toxicity concerns, philosophical differences in the therapy backbone, and regulatory and infrastructure barriers. Clinical Trials.gov ID: NCT02180867.",

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AU - Avutu, Viswatej

AU - Weiss, Aaron R.

AU - Reed, Damon R.

AU - Ahmed, Safia K.

AU - Allen-Rhoades, Wendy A.

AU - Chen, Yen Lin E.

AU - Davis, Lara E.

AU - Eaton, Bree R.

AU - Hawkins, Douglas S.

AU - Indelicato, Danny J.

AU - Patel, Shreyaskumar R.

AU - Randall, R. Lor

AU - Reinke, Denise K.

AU - Riedel, Richard F.

AU - Scharschmidt, Thomas J.

AU - Thornton, Katherine A.

AU - Wang, Dian

AU - Janeway, Katherine A.

AU - Kopp, Lisa M.

PY - 2022/6/1

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AB - ARST1321, a trial of patients with advanced soft tissue sarcoma, was the first National Clinical Trials Network study codeveloped by pediatric and adult consortia with two treatment cohorts. We report on the findings of a survey to identify barriers to enrolling adolescent and young adult patients (15-39 years) onto the nonchemotherapy arm. The survey response rate was 31% with a 70% completion rate. Common identified reasons for low accrual in order of decreasing frequency included insufficient funding, lack of study awareness or interest, competing trials, toxicity concerns, philosophical differences in the therapy backbone, and regulatory and infrastructure barriers. Clinical Trials.gov ID: NCT02180867.

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Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321

Abstract

Keywords

ASJC Scopus subject areas

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