title: A cluster randomized trial of a primary palliative care intervention (CONNECT) for patients with advanced cancer: Protocol and key design considerations.
abstract: The addition of specialty palliative care to standard oncology care improves outcomes for patients with advanced cancer and their caregivers, but many lack access to specialty care services. Primary palliative care-meaning basic palliative care services provided by clinicians who are not palliative care specialists-is an alternative approach that has not been rigorously evaluated.
  
  
  
  A cluster randomized, controlled trial of the CONNECT (Care management by Oncology Nurses to address supportive care needs) intervention, an oncology nurse-led care management approach to providing primary palliative care for patients with advanced cancer and their family caregivers, is currently underway at 16 oncology practices in Western Pennsylvania. Existing oncology nurses are trained to provide symptom management and emotional support, engage patients and families in advance care planning, and coordinate appropriate care using evidence-based care management strategies. The trial will assess the impact of CONNECT versus standard oncology care on patient quality of life (primary outcome), symptom burden, and mood; caregiver burden and mood; and healthcare resource use.
  
  
  
  This trial addresses the need for more accessible models of palliative care by evaluating an intervention led by oncology nurses that can be widely disseminated in community oncology settings. The design confronts potential biases in palliative care research by randomizing at the practice level to avoid contamination, enrolling patients prior to informing them of group allocation, and conducting blinded outcome assessments. By collecting patient, caregiver, and healthcare utilization outcomes, the trial will enable understanding of the full range of a primary palliative care intervention's impact.
authors.affiliation: University of Pittsburgh, School of Medicine, United States.
authors.forename: Claire L
authors.initials: CL
authors.lastname: Becker
authors.affiliation: Division of General Internal Medicine, University of Pittsburgh, United States.
authors.forename: Robert M
authors.initials: RM
authors.lastname: Arnold
authors.affiliation: Division of General Internal Medicine, University of Pittsburgh, United States.
authors.forename: Seo Young
authors.initials: SY
authors.lastname: Park
authors.affiliation: School of Nursing, University of Pittsburgh, United States.
authors.forename: Margaret
authors.initials: M
authors.lastname: Rosenzweig
authors.affiliation: Johns Hopkins Medical Institutions, Sidney Kimmel Comprehensive Cancer Center, United States.
authors.forename: Thomas J
authors.initials: TJ
authors.lastname: Smith
authors.affiliation: Department of Critical Care Medicine, University of Pittsburgh, United States.
authors.forename: Douglas B
authors.initials: DB
authors.lastname: White
authors.affiliation: Division of General Internal Medicine, University of Pittsburgh, United States.
authors.forename: Kenneth J
authors.initials: KJ
authors.lastname: Smith
authors.affiliation: Division of General Internal Medicine, University of Pittsburgh, United States. Electronic address: schenkery@upmc.edu.
authors.forename: Yael
authors.initials: Y
authors.lastname: Schenker
mesh_terms: D032722:Advance Care Planning; D017028:Caregivers; D017281:Cost of Illness; D006801:Humans; D009369:Neoplasms / Q000473:pathology / Q000628:therapy*; D009859:Oncology Nursing; D010166:Palliative Care / Q000379:methods*; D010414:Pennsylvania; D057184:Practice Patterns, Nurses'; D011320:Primary Health Care; D011788:Quality of Life; D020377:Self Efficacy; D012944:Social Support
keywords: Behavioral intervention; Caregiver; Cluster randomization; Oncology nursing; Primary palliative care; Quality of life