A randomized controlled trial of the effect of a community-based intervention on patient activation, health-related quality of life, and acute care use.

1 Background: Low-income and minority populations have disproportionately less activation in their cancer care, worse health-related quality of life (HrQOL), and greater acute care use than affluent and white populations. Community-based interventions are needed to improve patient experiences and quality of cancer care among these populations. We used community-based participatory methods to refine a previously tested intervention for use in Atlantic City NJ. The intervention, LEAPS, uses community health workers trained to activate patients to discuss advance care planning and their symptom burden with cancer clinicians and to connect patients with culturally-relevant community resources to overcome complications from social determinants of health. We conducted a randomized controlled trial of LEAPS in collaboration with a employer-union health fund. Members of the employer-union health fund with newly diagnosed with hematologic and solid tumor cancers were randomized to the 6-month intervention or to usual care. The objective was to determine if the intervention improved HrQOL at 4 months post-enrollment as compared to baseline more than usual care and secondarily the effect on change in patient activation at 4 months post-enrollment as compared to baseline and acute care use within 12 months post-enrollment. Methods: We conducted patient interviews to assess HrQOL and patient activation and obtained claims data for health care use. We used regression models to evaluate differences in health-related quality of life (validated Functional Assessment of Cancer Therapy-General) scores and patient activation (validated Patient Activation Measure) scores between groups over time and exact poisson regression adjusted for length of follow-up to compare emergency department and hospitalization utilization. Results: A total of 160 patients were consented and randomized into the study (80 intervention; 80 control). There were no differences in demographic or clinical factors across groups. The majority were non-white (74%), female (53%), mean age 57 years. The most common diagnoses were breast (31%) and lung (21%) cancer and the majority were diagnosed with stage 3 or 4 (63%). At 4 months, the intervention group had greater improvements in quality of life as compared to the control group (difference in difference: 9.56 p < 0.001), greater change in patient activation (difference in difference: 12.43 (p < 0.001)), and lower acute care use (hospital visits (1.10 (1.53) +/- 1.83 (1.31), p = 0.02) and emergency department use (1.2 (2.82) versus 3.47 (3.62) p = 0.03). Conclusions: Integration of community-based interventions into cancer care for low-income and minority populations may be a more effective and sustainable way to ensure equitable cancer care. Clinical trial information: NCT03699748.