Phase 1 clinical trial patients are generally among the most "well" of advanced disease cancer patients but have a significant symptom burden. In addition to a baseline symptom burden, Phase 1 clinical trials are known to increase potential symptoms, worsen patient performance status, and confer substantial toxicities that result in multiple clinic visits and time from family. Patients treated on Phase 1 trials may benefit from interdisciplinary palliative care (PC) that supports hopes for symptom relief, psychosocial support, and better understanding of their illness goals and treatment options while concurrently receiving disease-directed therapies. The overall purpose of this proposal is to test the efficacy of a concurrent palliative care intervention (PCI) for patients with solid tumors who are receiving disease-directed treatments in Phase 1 clinical trials.
Specific aims i nclude testing the efficacy of the PCI on patients'quality of life (QOL), psychological distress, symptom intensity and interference with daily activities, hospital and PC resource utilization, overall survival, mediatos of intervention outcome, and patient satisfaction with the intervention. This collaborative project involves investigators from the City of Hope and the Sidney Kimmel Comprehensive Cancer Center of the Johns Hopkins Medical Institutes, and utilizes the National Consensus Project's Clinical Practice Guidelines for Quality Palliative Care to guide study design. The study will utilize a randomized design, where patients enrolled in the study will be randomized to either receiving early PC or delayed PC, and patients will be followed for 24 weeks. This is a highly innovative RCT which applies a comprehensive PCI adapted from the PI's current Program Project (P01) in lung cancer. The study applies this innovative intervention to a novel area of PC applied to Phase 1 trial patients, one of the most vulnerable patient groups.
Palliative care provides better communication, symptom control, knowledge about treatment options and goals, and improved survival for advanced cancer patients. Patients treated on Phase 1 clinical trials may benefit from interdisciplinary palliative care that supports symptom relief, psychosocial support, and better understanding of their illness goals and treatment options while concurrently receiving disease-directed therapies. Palliative care could also benefit the patient and cancer science if such care can result in patients staying on the clinical trials longer and with better management of treatment toxicities.
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