An evaluation of the psychological impact of early phase clinical trials in cancer patients

Abstract

Background The prevalence of anxiety and depression in cancer patients (pts) is approximately 20% and 10% respectively. This is associated with decreased quality of life and increased morbidity and mortality but is often overlooked and untreated. Early phase clinical trials (EPCTs) recruit pts with advanced cancers who frequently lack future treatment options, which may lead to increased anxiety and depression. Despite this, EPCTs do not routinely consider any psychological screening. To our knowledge, this prospective observational study explores levels of anxiety and depression in addition to impact of trial participation in the context of EPCT for the first time. Methods From September 2018 to June 2019, cancer pts attending clinic to consent for an EPCT were invited to take part. The Hospital Anxiety and Depression Scale (HADS) was used to measure anxiety and depression. Pts completed questionnaires at the point of EPCT consent, at the end of screening and at pre-specified time points thereafter. Results 64 pts (median age 56 (range 21-77); 56% (N = 36) female; median ECOG Performance Status 1 (N = 44)) were recruited. At consent 57 pts returned questionnaires; 39% (N = 22) reported clinically relevant levels of anxiety whilst 18% (N = 10) reported clinically relevant levels of depression on the HADS. Of those pts experiencing psychological distress before EPCT enrolment, 63% had never reported this to a health care professional. 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. Conclusions EPCT pts are at an increased risk of anxiety and depression and may not openly seek support for this. This study did not demonstrate that the psychological wellbeing of pts was improved by participating in an EPCT. These findings should be regarded when EPCTs are discussed with pts but require validation in a larger cohort. Sites offering EPCTs should consider including an element of psychological screening in order to encourage a more holistic approach to cancer care. Subsequent interventions should consider the gender of individuals when tailoring psychological support to meet specific needs.