In addition, only 50% of study participants could identify the purpose of the trial. The patients who correctly identified the purpose had greater cognitive functioning compared with the patients who did not, with greater scores for memory (P = .001), attention (P < .001), visual attention (P = .001), and executive function (P < .001). Patients who were highly educated were also more likely to identify the trial purpose compared with patients who were less educated (53% vs 27%; P = .03).

“It may be that these patients [are] more likely to identify the phase 1 purpose given they receive and seek out information regarding phase 1 [studies] differently, [and are] utilizing additional resources outside [of] the clinical encounter, including [information learned from] family/friends, the internet, or research [collected from] phase 1,” Dr Hlubocky said. “Indeed, our results provide critical evidence for the need for cognitive and educational interventions designed to address the unique decision-making and information needs of this population.”


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Younger patients had a greater likelihood of recalling the purpose of the trial compared with those aged 60 or older (70% vs 30%; P = .02). Older patients also had greater deficits in total memory (P = .002), attention (P < .001), and executive function (P = .01).

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“Although cognitive impairment is likely multifactorial, involving many contributors such as fatigue, psychological distress, insomnia, or poor physical functioning and quality of life, a formal assessment of these cognitive symptoms in the clinical setting during the informed consent discussion is vital to ensure that patients have the ability to make a decision to participate in a phase 1 trial,” Dr Hlubocky said. “These symptoms, if left unaddressed, are likely to impair decisional capacity.”

Reference

  1. Hlubocky FJ, Sachs GA, Larson ER, et al. Do patients with advanced cancer have the ability to make informed decisions for participation in phase 1 clinical trials [published online July 9, 2018]? J Clin Oncol. doi: 10.1200/JCO.2017.73.3592