Psychological distress in patients with metastatic cancer enrolling on phase I clinical trials

Alexandra Hunt, Elizabeth Handorf, Matthew Blau, Yana Chertock, Carolyn Fang, Michael J. Hall, Rishi Jain

Research output: Contribution to journalArticlepeer-review

3 Scopus citations


Purpose: Psychological distress is common in patients with cancer and is associated with lower quality-of-life (QOL). Although distress among oncology outpatients undergoing standard therapy has been widely studied, few studies have evaluated distress among patients enrolling on Phase I therapeutic clinical trials. Thus, we aimed to characterize levels of distress and types of stressors in patients enrolling on Phase I clinical trials. Methods: Participants completed the National Comprehensive Cancer Network Distress Thermometer (NCCN DT) and Problem list and measures of anxiety and depression at the time of Phase I clinical trial initiation. Results: We enrolled 87 patients (95% with metastatic/incurable disease) who were initiating a Phase I clinical trial. Analyses revealed a high prevalence of distress (51%) and anxiety (28%). There were significant correlations between overall distress and practical problems (r = 0.31, p = 0.016), family problems (r = 0.35, p = 0.006), and emotional problems (r = 0.64, p < 0.001), but not physical problems (r = 0.17, p = 0.206). Conclusions: Patients may be better prepared to manage physical stressors but not practical, emotional, or family stressors at the time of Phase I trial enrollment. Implications for Cancer Survivors: Phase I trial patients experience high levels of distress which may be due to the rigors of previous therapies therapy and related emotional and social stressors related to the poor prognosis of their advanced cancer diagnosis. Distress may go unidentified without screening which is not standard practice at the time of Phase I trial consideration. Future studies should evaluate strategies to routinely identify and intervene upon addressable stressors in patients participating in Phase I clinical trials.

Original languageEnglish
Pages (from-to)398-402
Number of pages5
JournalJournal of Cancer Survivorship
Issue number3
StatePublished - Jun 2021


  • Anxiety/epidemiology
  • Humans
  • Neoplasms
  • Psychological Distress
  • Quality of Life
  • Stress, Psychological/epidemiology


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