Patient perspectives on participation in phase 1 clinical trials.

48 Background: Patients with solid tumors in Phase 1 clinical trials are at an important phase in the cancer trajectory. Understanding patients’ experiences can guide healthcare providers to provide optimum care. The main objectives of this study were to describe patient perspectives on participating in a Phase 1 trial, understand their disease status and treatment options and, to describe the impact of the disease and clinical trial participation on quality of life (QOL). Methods: Phase 1 patients (n = 30) who were participating in a larger randomized NCI-funded intervention trial (n = 470), were interviewed and tape recorded. The interviews were transcribed and content analysis methods were used to identify common themes. Results: Patients reported participating in the Phase 1 clinical trial because their doctors informed and encouraged them, they had no other treatment options if they wanted to live longer, or they wanted to help future cancer patients. Most patients believed that participation would improve or stabilize their illness and improve quality of life. They believed that when the clinical trial ended, there would be new treatments available. Participants reported that the physicians, nursing staff, social worker, and their families had been supportive. They reported that the treatment had been difficult on their families. Patients reported that compassion, cultural awareness, spiritual support, and the need for individual attention was important. There was little mention of end-of-life care or advance care planning. Conclusions: Patients participating in Phase 1 trials remain optimistic about treatment options while aware of their mortality. They have important needs for support to address quality of life concerns as well as better understanding their disease status, treatment options, and advance care planning for end of life care. Clinical trial information: NCT01828775.