THE EFFECT OF A CANCER CLINICAL TRIALS DECISION AID ON PATIENTS' KNOWLEDGE AND DECISION PREPAREDNESS

Purpose: Participation in a cancer clinical trial (CCT) is a viable and appropriate treatment option for many newly diagnosed patients. To protect patient decision-making autonomy, cancer patients should be assisted in their efforts to make an informed choice about participation. Because notable barriers exist to making a well-informed decision for many cancer patients, interventions are needed to enhance patient engagement and agency in decision-making with regard to CCTs.

Method: The CHOICES DA was developed based on literature, telephone surveys of 1100 Florida cancer patients, and semi-structured interviews with cancer survivors. Following beta testing with 64 minority cancer survivors, a pilot randomized controlled trial (RCT) comparing the CHOICES DA vs. the NIH clinical trials webpage was performed with 104 newly diagnosed cancer patients. We assessed the effect of these two interventions on patient knowledge and preparedness to make a decision about participation in a trial at baseline (pre), immediately after viewing a website (post), and 2 week follow up. 

Result: In the RCT, there were no differences in age, gender, education or race/ethnicity of participants in the CHOICES DA (n=48) and NCI website (n=56) groups. Both intervention groups had significant increases from pre to post intervention in measures of self-reported knowledge, decision preparedness, and values clarification related to CCTs. However, there were few differences across intervention arms for these measures. Finally, objectively measured knowledge about CCTs increased significantly in both intervention arms, but did not differ between the arms.

Conclusion: In this study, we found significant increases in knowledge and decision preparedness from pre to post intervention, but few differences between the two arms of the intervention. In contrast, a RCT of the CHOICES DA and the Washington University Siteman cancer website in St. Louis, MO showed significantly greater improvement in decision preparedness and knowledge among cancer patients randomized to the CHOICES DA. Reasons for this disparity in effects should be explored, and the effect of the CHOICES DA on actual participation in CCTs needs to be established. However, the CHOICES DA shows substantial promise for improving patient decision-making about participation in CCT, and thus for enhancing patient engagement and autonomy in decision making.