Methods: A survey study has been conducted to explore patient informed consent experience, understanding of informed consent, autonomous decision making indicators, and the autonomy preference index. Autonomous decision making indicators include satisfaction with decision, decisional regret scale, and decisional conflict scale. The autonomy preference index contains two sections, decision making preference and information seeking preference. The higher scores indicate the desire of decision making and information seeking. Patients are eligible if they are older than 18 years, diagnosed with cancer, had been informed consent for a clinical trial within three months prior to being approached, and could concentrate on the study questionnaire for around 30 minutes. Data collection has been conducted in two medical centers in Taiwan.
Results: A total of 30 patients with cancer had been approached to complete the survey questionnaire. They all decided to participate in a clinical trial after informed consent process. Of these participants, over 73% were male; over 65% were high school graduates or below; over 96% lived with their family and near 75% had family/friends with them for clinic visits. For the informed consent process, nearly 40% of participants indicated they did not discuss or clarify their concerns with a medical team member if they did not understand the trial information being provided. Regarding the participant information and consent form, less than 35% of participants read the entire document before making a decision regarding trial participation; over 50% did not understand the content of this document and also did not discuss with a medical team member. For the autonomy preference index, the mean score of decision making preference was 13.85 with a full score of 30 and the mean score of information-seeking preference was 14.35 with a full score of 40, indicating patient were less interested in making decision themselves and information seeking. Better treatment response was associated with stronger preferences for decision making(r=.401, p<.05) and stronger preferences for information seeking(r=.527, p<.05). Participants who were more interested in information seeking were less satisfied with how decision were being made (r=-.592, p<.005) and felt more conflict with the decision they made(r=.444, p<.05).
Conclusion: The preliminary results showed that patient understanding of clinical trial needs to be improved. Patients tend to have low levels of decision making preferences and information seeking preferences. Treatment response, satisfaction with decision, and decisional conflict were associated with patient autonomy preference index. A large sample size is required for further data collection.