Mapping palliative care for people living with advanced cancer in phase 1 clinical trials: A scoping review

Background: Phase 1 cancer clinical trials offer potential disease modifying treatments for patients with advanced cancer who have not responded to standard treatments. These patients also experience palliative care needs that should be addressed. However, misunderstandings may arise between the goals of experimental treatments and the goals of palliative care, especially when the latter focuses on quality of life. Aim: This study aimed to map the existing literature on the provision and integration of palliative care within phase 1 clinical trials, identifying knowledge gaps and informing future research. Design: A systematic scoping review. Data sources: Studies published from 2003 to 2023 were identified through searches in PubMed, Web of Science, Scopus, CINAHL, PsycINFO and Google Scholar, focussing on people living with advanced cancer enrolled in phase 1 clinical trials. Results: Fifty studies were included from 452 screened. Key results revealed patients’ limited life expectancy, high symptom burden, distress and unmet spiritual needs. Notably, patients were reluctant to seek prognostic information or engage in end-of-life discussions, complicating advance care planning. End-of-life care involved frequent unscheduled hospital admissions, hospital deaths and late hospice-care referrals. Caregivers experienced significant distress, while healthcare professionals faced barriers to integrating palliative care. Palliative care interventions varied widely in approaches, settings and outcomes. Conclusion: This review highlights the unique needs of patients and caregivers in Phase 1 Cancer Clinical Trials and the complexities of integrating palliative care. Future research should focus on integrating specialised palliative care into oncology trials and developing standardised guidelines for clinical trial units.