A cluster randomized trial of a patient-centered communication intervention in advanced cancer: The Values and Options In Cancer Care (VOICE) study.

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2 Background: Observational studies demonstrate links between patient-centered communication, prognosis discordance, quality of life (QoL) and aggressive treatments near the end of life, yet there are few randomized evaluations of communication interventions in advanced cancer. Methods: We completed a cluster randomized controlled trial in cancer clinics in Western NY and Northern CA with medical oncologists (n = 38 randomized to intervention or control) and their community-dwelling adult patients with advanced non-hematologic cancer (n = 265; 194 with enrolled caregivers). Interventions foroncologists (individualized communication training using Standardized Patient Instructors) and patients/caregivers (individualized coaching using question prompt lists) were directed towards enhancing patient engagement in consultations, oncologists’ response to emotions, and provision of balanced information about prognosis and treatment choices. Oncologists and patients randomized to control received no interventions. Primary outcome was a composite of 4 communication measures coded from audio-recorded oncologist visits shortly after patient coaching (intervention) or enrollment (control). Secondary outcomes included the patient-physician relationship, shared understanding of prognosis, QoL, and utilization of aggressive treatments and hospice in the last 30 days of life. Results: In fully-adjusted models, the intervention significantly improved mean composite communication scores [0.34, 95% CI (0.06, 0.62), p = 0.017]. Effects on secondary outcomes were not significant. Conclusions: Oncologist communication training combined with coaching for patients with advanced cancer and available caregivers promoted patient-centered communication. Nevertheless, we did not observe changes in QoL and utilization, suggesting that more intensive, psychologically-oriented or longitudinal interventions may be needed, along with support and incentives for clinicians to participate. Clinical trial information: NCT01485627.