Background: Patient information in cancer clinical trial is challenging. The value of audio-recording interventions for patients considering participating in clinical trials is unclear. The primary aim of this randomized study was to investigate effects of audio-recorded information on knowledge and understanding in patients considering participation in a clinical trial.
Material and methods: Patients scheduled for information about a phases 2 or 3 trial by one of the 13 participating oncologists at the Department of Oncology during the study period (2008-2013) were eligible. The intervention consisted of an audio-recording on compact disc (CD) of the information at the medical consultation in which the patients were informed about a trial. Knowledge and understanding was measured by the questionnaire, Quality of Informed Consent.
Results: A total of 130 patients were randomized, 70% of the calculated sample size (n = 186). Sixty-seven patients were randomized to the intervention. In total, 101 patients (78%) completed questionnaires. No statistical significant differences were found between the groups with respect to knowledge and understanding. The level of knowledge was relatively high, with the exceptions of the risks associated with, and the unproven nature of, the trial. Overall, patients who declined participation scored statistically significant lower on knowledge.
Conclusion: The present study was underpowered and the results should therefore be interpreted with caution. Still, 130 patients were included with a response rate of 78%. A CD including the oral information about a clinical trial did not show any effects on knowledge or understanding. However, the levels of knowledge were high, possible due to the high levels of education in the study group. Information on risks associated with the trial is still an area for improvement.
Trial registration: ClinicalTrials.gov NCT01502254.