Goals of care and advanced care planning in phase I trials.

Abstract

80 Background: Cancer patients participating in phase 1 clinical trials often represent a population with advanced disease, symptoms and QOL impact from disease and treatment. This analysis was conducted using data from a randomized trial in progress testing a palliative care intervention for solid tumor patients on phase 1 trials to evaluate goals of care and advance care planning. Methods: In this analysis, the investigators evaluated chart audit data from patients at baseline and six months after initiating a phase 1 trial. Results: Patients (N = 284) were at a mean age of 60, 56% were female and 32% were ethnic minorities. Predominant diagnoses were lung cancer (18%), colon (15%), and pancreatic (12%) cancers. Thirty six percent (36%) of these patients died within six months of initiating the phase 1 trial. At six months post trial initiation, forty four percent (44%) had no advanced care plan and 58% remained full code status. Forty four percent of those who died were full code status. Forty five percent had no documented goals of care conversation and 32% had no proxy decision maker. Thirteen percent (13%) of those who died received chemotherapy in the last two weeks of life. Only forty four percent (44%) of those who died received hospice care and only fifty seven percent (57%) had received palliative care referrals. Conclusions: This data supports the need for palliative care for cancer patients on phase 1 cancer trials. There are important opportunities to integrate palliative care with cancer clinical trials for best supportive care of these patients.