138 Background: Cancer patients receiving Phase I clinical trials are a population with advanced disease, high symptom burden, and with multiple QOL concerns including use of advance directives. Methods: An NCI funded R01 is currently in progress (2014-2019) as a randomized clinical trial to test a palliative care intervention (PCI) in this population. The PCI includes comprehensive patient assessment, goals of care communication, interdisciplinary care planning and patient teaching. Aims and hypotheses test the impact of the PCI on symptoms, QOL, resource use, spirituality and distress. Outcomes for the study (N = 400) will be conducted at the conclusion of the RCT. This paper reports preliminary baseline data of the first 100 subjects accrued. Results: Subjects mean age was 59 years and 59% were female, similar to prior trials. Forty eight percent (48%) were ethnic minorities, higher than prior trials (3% non-white, Finlay E, 2014; 9%, Parsons JA, et al. PLoS One 2012) with colon (22%) and lung (21%) cancers as dominant. Patients had a mean of 2 comorbidities (range 0-8) and 40% of the patients are > 65 years of age. The most common symptoms reported by PRO-CTCAE (1 = least to 5 = most concern) were sexuality (4.2), fatigue (2.9), pain (2.6) and anxiety (2.5). Psychological Distress Thermometer, (0 - least to 10 = most distress) mean score was 4. FACIT spiritual concerns (1 = least to 5 = most concerning) identified greatest concerns of illness strengthening faith (2.0), strength from faith (2.0) and sense of harmony (2.6). There was limited use of supportive care services, PC consultation, or advanced directives. Conclusions: The population of Phase I trial patients is an important group for palliative care integration with major unmet needs in symptom management and advance care planning.
Impact of Hepatitis Virus on the Feasibility and Efficacy of Anticancer Agents in Patients With Hepatocellular Carcinoma in Phase I Clinical Trials