Background
Cancer clinical trials (CCTs) are important tools in the development of improved cancer therapies; yet, participation is low. Key psychosocial barriers exist that appear to impact a patient’s decision to participate. Little is known about the relationship among knowledge, self efficacy, preparation, decisional conflict, and patient decisions to take part in CCTs.
Objective
The purpose of this study was to determine if preparation for consideration of a CCT as a treatment option mediates the relationship between knowledge, self-efficacy, and decisional conflict. We also explored whether lower levels of decisional conflict are associated with greater likelihood of CCT enrollment.
Method
In a pre-post test intervention study, cancer patients (N=105) were recruited before their initial consultation with a medical oncologist. A brief educational intervention was provided to all patients. Patient self-report survey responses assessed knowledge, self efficacy, preparation for clinical trial participation, decisional conflict, and clinical trial participation.
Results
Preparation was found to mediate the relationship between self-efficacy and decisional conflict (p=0.003 for a test of the indirect mediational pathway for the Decisional Conflict total score). Preparation had a more limited role in mediating the effect of knowledge on decisional conflict. Further, preliminary evidence indicated that reduced decisional conflict was associated with increased clinical trial enrollment (p=0.049).
Conclusions
When patients feel greater CCT self-efficacy and have more knowledge they feel more prepared to make a CCT decision. Reduced decisional conflict, in turn, is associated with the decision to enroll in a clinical trial. Our results suggest that preparation for decision making should be a target of future interventions to improve participation in CCTs.