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Clinical Trial Participation: A Qualitative Study of Adolescents and Younger Adults Recently Diagnosed with Cancer.

Purpose: Although participation of adolescents and young adults (AYAs) in cancer clinical trials (CCTs, i.e., cancer-directed treatment studies) is low, their decision-making perspectives are not well understood, especially following recent diagnosis. Methods: Semistructured interviews with younger AYAs (15-21 years old) eligible for a CCT were to be held within 60 days of beginning treatment at Children's Hospital Los Angeles, an academic pediatric hospital. Using grounded theory methods, key themes regarding CCT participation, barriers, and facilitators were identified from interview transcripts. Thematic saturation was confirmed. Results: Of nine participants, three were <18 years old, four Hispanic, six male, six diagnosed with leukemia, eight enrolled in a CCT, and eight also enrolled in ancillary studies. Four overarching themes emerged: (1) Initial Consent encompassed the first discussion of CCT with patients reflecting positive and negative effects of timing, decisional role, and the emotional impact following cancer diagnosis; (2) Informing Participation involved decision-making processes, specific knowledge, comprehension, and external influences; (3) Participant Relationships emphasized the importance of communication and relationships with providers and parents; and (4) Patient Determinants centered on motives from different perspectives, pre-conceived attitudes, and understanding of CCTs. Conclusion: Recommendations for improving CCT participation among younger AYAs include separating the diagnosis/treatment and CCT discussions, assigning AYAs a meaningful decisional role, having ongoing provider conversations, designing trials to minimize burden, and developing age-appropriate decision aids.