A cluster randomized trial of a primary palliative care intervention (CONNECT) for patients with advanced cancer

Patients with advanced cancer experience steep declines in quality of life and receive non-beneficial aggressive treatments near the end of life. Their caregivers suffer from high rates of burden and psychological distress. Deficiencies in standard oncology care-including inadequate attention to symptom control, emotional support, and engagement in advance care planning-contribute to morbidity in this population. While early co- management by a palliative care specialist may improve patient and caregiver outcomes, this is not a practical solution for most patients with cancer because of workforce shortages. A practical solution to mitigating these public health problems will require `primary' palliative care interventions-meaning palliative care that is integrated within oncology practices and delivered by clinicians who are not specialists. CONNECT (Care management by Oncology Nurses to address supportive care needs) is an oncology practice- based primary palliative care intervention that was developed and successfully pilot-tested in work funded by the National Palliative Care Research Center and the NIH. Conceptually grounded in Wagner's chronic care model, CONNECT employs an oncology nurse-led care management approach to (1) address patients' symptom needs, (2) engage patients and caregivers in advance care planning, (3) provide emotional support to patients and caregivers, and (4) communicate with oncologists and coordinate appropriate care. The objective of this proposal is to test the efficacy of CONNECT in a cluster-randomized trial conducted among 672 patients with advanced cancer and their caregivers receiving care at 16 community oncology clinics. Aim 1 assesses the effects of CONNECT on patient quality of life (primary outcome, measured using the Functional Assessment of Chronic Illness Therapy - Palliative Care), symptom burden (Edmonton Symptom Assessment Scale), and depression and anxiety symptoms (Hospital Anxiety and Depression Scale). Aim 2 assesses the effects of CONNECT on caregiver burden (Zarit Burden Interview-Short) and caregiver depression and anxiety symptoms (Hospital Anxiety and Depression Scale). Aim 3 assesses the effects of CONNECT on healthcare resource use. All patient and caregiver outcomes will be assessed at 3 months, a time-point chosen to allow an adequate "dose" of the intervention while minimizing loss to follow-up in a seriously ill population. Healthcare utilization, cost outcomes, and survival will be measured for up to one year to understand effects that may persist beyond the intervention period. The CONNECT intervention will have a high impact if successful because it will be a pragmatic solution to important public health problems that potentially affect more 600,000 patients who die annually with advanced cancer and their caregivers. It is innovative in shifting the paradigm that has focused on provision of specialty palliative care to rigorously test an oncology nurse-led primary palliative care approach. It is feasible because it builds on extensive pilot work by an experienced research team and enjoys strong support from health system leadership and oncology clinical staff.