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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.

Abstract：

BACKGROUND: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. METHODS: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. DISCUSSION: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.

journal_name

Contemp Clin Trials

journal_title

Contemporary clinical trials

authors

Becker CL,Arnold RM,Park SY,Rosenzweig M,Smith TJ,White DB,Smith KJ,Schenker Y

doi

10.1016/j.cct.2017.01.005

subject

Has Abstract

pub_date

2017-03-01 00:00:00

pages

98-104

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(16)30371-8

journal_volume

54

pub_type

杂志文章,随机对照试验

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