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      A cluster randomized trial of a primary palliative care intervention (CONNECT) for patients with advanced cancer: Protocol and key design considerations

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          Abstract

          <div class="section"> <a class="named-anchor" id="S1"> <!-- named anchor --> </a> <h5 class="section-title" id="d14549204e195">Background</h5> <p id="P1">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. </p> </div><div class="section"> <a class="named-anchor" id="S2"> <!-- named anchor --> </a> <h5 class="section-title" id="d14549204e200">Methods</h5> <p id="P2">A cluster randomized, controlled trial of the CONNECT ( <span style="text-decoration: underline">C</span>are management by <span style="text-decoration: underline">O</span>ncology <span style="text-decoration: underline">N</span>urses 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. </p> </div><div class="section"> <a class="named-anchor" id="S3"> <!-- named anchor --> </a> <h5 class="section-title" id="d14549204e214">Discussion</h5> <p id="P3">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. </p> </div>

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          Author and article information

          Journal
          Contemporary Clinical Trials
          Contemporary Clinical Trials
          Elsevier BV
          15517144
          March 2017
          March 2017
          : 54
          : 98-104
          Article
          10.1016/j.cct.2017.01.005
          5331884
          28104470
          5768357e-81a4-4dfa-9e4e-6cfa899f63d6
          © 2017

          https://www.elsevier.com/tdm/userlicense/1.0/

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