EPIC: An Evaluation of the Psychological Impact of Early Phase Clinical Trials in Cancer Patients

P. Jittla, Donna Graham, C. Zhou, J. Halliwell, S. O'Reilly, S. Aruketty, A. Azizi, T. Germetaki, J. Lowe, M. Little, Grant Punnett, P. McMahon, L. Benson, Louise Carter, Matthew Krebs, Fiona Thistlethwaite, Emma Darlington, Janelle Yorke, Natalie Cook

Research output: Contribution to journalArticlepeer-review


Anxiety and depression in patients with cancer is associated with decreased quality of life and increased morbidity and mortality. However, these are often overlooked and untreated. Early phase clinical trials (EPCTs) recruit patients with advanced cancers who frequently lack future treatment options, which may lead to increased anxiety and depression. Despite this, EPCTs do not routinely consider psychological screening for patients.

This prospective observational study explored levels of anxiety and depression alongside impact of trial participation in the context of EPCTs. The Hospital Anxiety and Depression Scale (HADS), and the Brief Illness Perceptions Questionnaire (Brief-IPQ) were completed at the point of EPCT consent, the end of screening and at pre-specified timepoints thereafter.

64 patients (median age 56 years; median ECOG Performance Status 1) were recruited. At consent 57 patients returned questionnaires; 39% reported clinically relevant levels of anxiety whilst 18% reported clinically relevant levels of depression. 63% of patients experiencing psychological distress had never previously reported this. Males were more likely to be depressed (p = 0.037) and females were more likely to be anxious (p = 0.011). Changes in anxiety or depression were observed after trial enrolment on an individual level, but not significant on a population level.

Patients on EPCTs are at an increased risk of anxiety and depression but may not seek relevant support. Sites offering EPCTs should consider including psychological screening to encourage a more holistic approach to cancer care and consider the sex of individuals when tailoring psychological support to meet specific needs.
Original languageEnglish
JournalESMO Open
Publication statusAccepted/In press - 27 Jun 2022


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