Effect of a Volunteer-Led Precision-Medicine Multilevel Intervention on Patient-Reported Outcomes, Receipt of Biomarker Testing, and Time to Treatment: A Randomized Clinical Trial.

Abstract

Purpose: We developed and tested whether a multilevel intervention in which a trained volunteer (1) educated patients and (2) alerted clinicians if biomarker results were unavailable improved patient knowledge of precision medicine (primary outcome) and secondary outcomes including patient activation, satisfaction with decision making, molecular testing, and time to treatment more than usual care alone (control group).

Methods: Between April 15, 2023, and May 20, 2024, we enrolled veterans age >18 years with any stage of non-small cell lung cancer. Participants completed assessments at random assignment and 1-month follow-up and were followed for 6 months. We reviewed electronic health records for molecular testing and time to treatment and compared all outcomes using regression models.

Results: Of the 75 screened, 46 were eligible and participated. All were male (100%); the mean age (standard deviation [SD]) was 76.3 (5.54) years; 31 (67.4%) were Hispanic or Latino, two (4.4%) Asian, 11 (23.9%) Black, one (2.2%) Native Hawaiian, and 32 (69.6%) White. Knowledge, activation, and satisfaction increased more in the intervention than in the control (mean [SD]: knowledge 2.30 [0.97] v 1.16 [1.15], mean difference over time, 0.25 [95% CI, 0.19 to 0.29], P < .001); mean [SD] activation 46.7 [11.3] v 37.6 [9.26], mean difference over time, 9.28 [95% CI, 3.42 to 15.14], P < .001; mean [SD] satisfaction 34.7 [1.49] v 24.8 [8.67], mean difference over time, 13.9 [95% CI, 3.50 to 24.41], P = .009, respectively). There were no differences in molecular testing (intervention: 95.6% v control: 86.9%, odds ratio, 3.30, 95% CI, 0.32 to 34.9, P = .30). Time to treatment was lower in the intervention by mean (SD) 1.35 (0.58) months (95% CI, 0.19 to 2.53, P = .02).

Conclusion: This approach may improve veteran lung cancer care.