Abstract 591P
Background
It is important to ensure equal access to and adequate understanding of study premises in phase I trials. The trajectory of psychological distress associated with enrolment into phase I cancer trials and understanding of informed consent among patients and relatives in a phase I setting has not previously been investigated.
Methods
The association between levels of distress and later enrolment into phase I trial was investigated using a Cox regression model for referred patients (N=205). As the first study we investigated the understanding of informed consent among enrolled patients (N=46) and their relatives (N=35). The association between distress and understanding of informed consent was investigated using linear mixed-effects models.
Results
We identified no association with enrolment for a high level of stress compared to low (adjusted hazard ratio (HR), 1.8; 95% CI, 0.9 to 3.4); for mild symptoms of anxiety compared to minimal (HR, 1.0; 95% CI, 0.5 to 1.9); for moderate/severe symptoms of anxiety compared to minimal (HR, 1.2; 95% CI, 0.5 to 3.2); or for mild symptoms of depression compared to minimal (HR, 0.8; 95% CI, 0.4 to 1.6). Patients’ and relatives’ understanding of informed consent in complex phase I trials was near the level reported for cancer trials in general, although some aspects were only understood by a minority. There was no difference in understanding of informed consent according to levels of distress, neither for patients nor relatives (p > 0.05 for all three measures of distress).
Conclusions
Our results suggest that distress does not compromise enrolment or understanding of informed consent in phase I trials.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
A.P. Møller Foundation, Danish Cancer Society, and The Health Foundation.
Disclosure
All authors have declared no conflicts of interest.