Community Health Workers and Precision Medicine: Results of a Randomized Clinical Trial on Patient Knowledge,...

Background/Objectives: Molecular testing and targeted therapeutics remain inequitably delivered among patients with cancer. In response, we refined a multilevel intervention directed at clinicians, payers, and patients to determine whether it could improve patient knowledge and receipt of precision cancer care more than an intervention directed at clinicians and payers alone. Methods: This patient-level randomized trial was conducted in a community oncology clinic among low income and racial and ethnic minority adults who were newly diagnosed with cancer or relapsed disease. We compared a two-level enhanced usual care intervention, in which patients received usual care, clinicians received annual precision medicine training, and payers eliminated prior authorization for molecular testing and targeted therapeutics (control group), with a three-level intervention, in which patients received enhanced usual care along with a patient-level 12 month precision medicine education component led by community health workers (intervention group). The primary outcome was precision medicine knowledge. Secondary outcomes were health-related quality of life (HRQOL), patient activation, satisfaction, acute care use, molecular testing, and targeted treatment. Results: Among 110 participants, the three-level intervention resulted in greater improvement in knowledge of precision medicine compared with the two-level control group (mean difference of 4.17, 95% CI of 2.33-7.48; p < 0.001). Intervention participants also had greater patient activation and satisfaction with care, fewer emergency department visits and hospitalizations, and greater receipt of molecular testing and targeted therapy compared with patients in the control group. Conclusions: Multilevel interventions that include patient-level education can improve care delivery gaps. Trial Registration: clinicaltrials.gov, NCT04843332.