Introduction

Current data demonstrate that understanding of cancer clinical trials (CT) is variable with an estimated 40% of potential trial participants not understanding the essential elements of informed consent in the first instance. In 2008 the Medical Oncology Clinical Trials Unit at Calvary Mater Newcastle (CMN) commenced a quality project to assess participant’s post-decision understanding of the study to which they consented.  We used a validated post-decision survey, the Quality of Informed Consent (QUiC), to measure participants’ actual (objective) and perceived (subjective) understanding of cancer CT.

Methods

HREC approval as a quality project was granted prior to starting.

Participants who consented to a randomised CT between July 2008 and July 2014 were invited to complete the survey 2-4 weeks post decision. The QUiC survey was introduced by an independent trial coordinator not involved in the participant’s consent process. Completed questionnaires were reviewed by the responsible trial coordinator to clarify areas of uncertainty with participants.

Results

100 participants completed the QUiC survey. Results show that all participants knew they were participating in a CT and that participation was voluntary. Participant understanding was variable in the following areas: dosing schedules, standard of care treatments, additional risks and discomforts, proven treatments and compensation if injured as a participant in a CT.

The average objective score of participants was 78% and the average subjective score was 91%. These scores indicate that although some deficits in participants’ objective understanding exist, subjectively they generally perceive their understanding of the clinical trial to be good.

Conclusion

The QUiC survey proved to be a particularly useful tool in identifying participants with inadequate understanding of the essential elements of CT participation. This enabled us to identify and address weaknesses in departmental consent processes.

Survey findings indicate that the majority of participants in our department had a good understanding of their CT.