Effect of Apoyo con Cariño (Support With Caring) Trial of a Patient Navigator Intervention to Improve Palliative Care Outcomes for Latino Adults With Advanced Cancer: A Randomized Clinical Trial.

Importance: Strategies to increase access to palliative care, particularly for racial/ethnic minorities, must maximize primary palliative care and community-based models to meet the ever-growing need in a culturally sensitive and congruent manner. Objective: To investigate if a culturally tailored patient navigator intervention can improve palliative care outcomes for Latino adults with advanced cancer. Design, Setting, and Participants: The Apoyo con Cariño (Support With Caring) randomized clinical trial was conducted from July 2012 to March 2016. The setting was clinics across the state of Colorado, including an academic National Cancer Institute-designated cancer center, community cancer clinics (urban and rural), and a safety-net cancer center. Participants were adults who self-identified as Latino and were being treated for advanced cancer. Intervention: Culturally tailored patient navigator intervention. Main Outcomes and Measures: Primary outcome measures were advance care planning in the medical record, the Brief Pain Inventory, and hospice use. Secondary outcome measures included the McGill Quality of Life Questionnaire (MQOL), hospice length of stay, and aggressiveness of care at the end of life. This study used an intent-to-treat design. Results: In total, 223 Latino adults enrolled (mean [SD] age, 58.1 [13.6] years; 55.6% female) and were randomized to control (n = 111) or intervention (n = 112) groups. Intervention group patients were more likely to have a documented advance directive compared with control group patients (73 of 112 [65.2%] vs 40 of 111 [36.0%], P < .001). Both groups reported mild pain intensity (mean pain rating of 3 on a scale of 0-10). Intervention group patients had a mean (SD) reported change from baseline in the Brief Pain Inventory pain severity subscale score (range, 0-10) of 0.1 (2.6) vs 0.2 (2.7) in control group patients (P = .88) and a mean (SD) reported change from baseline in the Brief Pain Inventory pain interference subscale score of 0.1 (3.2) vs -0.2 (3.0) in control group patients (P = .66). Hospice use was similar in both groups. Secondary outcomes of overall MQOL score and aggressiveness of care at the end of life showed no significant differences between groups. The MQOL physical subscale showed a mean (SD) significant change from baseline of 1.4 (3.1) in the intervention group vs 0.1 (3.0) in the control group (P = .004). Conclusions and Relevance: The intervention had mixed results. The intervention increased advance care planning and improved physical symptoms; however, it had no effect on pain management and hospice use or overall quality of life. Further research is needed to determine the role and scope of lay navigators in palliative care. Trial Registration: ClinicalTrials.gov identifier: NCT01695382.