Feasibility, acceptability, and effectiveness of a decision aid versus an informational website to promote clinical trial decision-making among cancer patients: A pilot randomized controlled trial

Abstract

Objective: To assess intervention feasibility and acceptability, and compare the effectiveness of the CHOICES Decision Aid (DA) versus the National Cancer Institute (NCI) Cancer Clinical Trials (CCT) website to improve knowledge about CCTs and preparedness to make an informed decision.

Methods: Oncology patients (n = 101) with a scheduled clinic visit were enrolled and randomized. Decision-making variables were collected at two timepoints. Post-intervention scores were examined via paired t-tests and multivariate regression analyses. Predictors of the magnitudes of the change in scores were examined in multivariable regression analyses.

Results: The interventions were feasible to implement and acceptable to participants. Both interventions increased objective and subjective knowledge, improved clarity of opinions, and reduced decisional conflict (p-values < 0.01). Improvements in the belief that one could find out about CCTs were observed in the CHOICES DA arm (p < 0.001). Multivariable analyses controlling for educational attainment showed no significant differences in the magnitude of change in outcome variables between intervention arms, but did find that improvements in some variables in the NCI arm - but not CHOICES DA arm - were associated with previous educational attainment.

Conclusions: Interventions were feasible to implement and acceptable. Improvements in knowledge and decision-making outcomes were observed in both arms, supporting the view that interventions to improve CCT decision making are effective and feasible. Our results suggest that the CHOICES DA may be more effective than an informational website in improving decision-making outcomes regardless of participants' educational attainment.

Practice implications: CCT resources should support informed decision-making among all cancer survivors, regardless of educational attainment.

Keywords: Acceptability; Cancer patients; Cancer treatment; Clinical trial; Decision aid; Decision-making; Empowerment; Feasibility; Knowledge; Values clarification.