Understanding the decisions of cancer clinical trial participants to enter research studies: factors associated with informed consent, patient satisfaction, and decisional regret

Abstract

Objective: To understand the psychosocial outcomes related to decision-making processes of individuals eligible for participation in clinical trials.

Methods: Individuals eligible to participate in selected clinical trials were contacted to complete two surveys; one shortly after participants were identified, and the second 6 weeks after the first survey was completed (N=50). Measures included subjective informed consent; satisfaction with decision-making; decisional regret; and timing of consent (early versus late signers). ANOVA and correlation coefficients were used to test the relationships between variables.

Results: Early signers reported themselves to be less informed about the details of their particular clinical trials than later signers (M=81.9 versus 91.2; F=5.5; p=.02). There was a non-significant trend for early signers to be less satisfied with their decisions than late signers. Satisfaction with decision-making and subjective informed consent were both strongly associated with later decisional regret (r=-.32 and -.30, respectively). However, there was no relationship between timing of consent and decisional regret.

Conclusion: Participants who enroll in clinical trials quickly may not believe they fully understand the implications of trial participation. In general, participants who do not believe they fully understand the implications of trial participation, or who are less satisfied with their decision to enroll in the trial may ultimately feel regret about their decision to participate.

Practice implications: More effort is needed to ensure that clinical trial participants fully understand the risks and benefits of participation and are satisfied with their decision to enroll in a trial prior to signing consent forms.