Feasibility of a palliative care intervention for cancer patients in Phase I clinical trials.

BACKGROUND Cancer patients with advanced disease who have exhausted most treatment options are often offered participation in Phase I clinical trials. To date, studies that assess the benefits of palliative care provided concurrently in Phase I clinical trial settings are lacking. The overall purpose of this study was to test the feasibility of a palliative care intervention administered concurrently to cancer patients receiving treatment in a Phase I clinical trial. METHODS Cancer patients enrolling in a Phase I clinical trial were invited to participate in this study. Patients completed baseline questionnaires prior to treatment initiation that assessed quality of life (QOL), symptom distress, psychological distress, and satisfaction with care. Patients then received the palliative care intervention (PCI), which consisted of comprehensive QOL assessment, care planning for the patient during an interdisciplinary team meeting, and two patient education sessions. Patients were surveyed again at 1 and 2 months following treatment initiation. RESULTS A total of 14 patients were accrued to the pilot over a 3-month time period, representing 70% of eligible patients. Patient retention was high at 1 month (75%), and had declined at 2 months (50%). Patient outcome measure scores, including symptom distress, psychological distress, and satisfaction with care, were relatively stable over time, except for overall QOL, which declined over time. CONCLUSIONS Concurrent palliative care is feasible for cancer patients treated in Phase I clinical trial settings. A large, multisite randomized controlled trial based on this pilot will be launched to test the efficacy of the intervention in this understudied cancer population.