KEY TAKEAWAYS
- The CONSENT trial aimed to test whether enhanced informed consent can help pts understand clinical trials better.
- The primary endpoint was the difference in QuIC-A score between the control and experimental arms.
- The study showed that online communication interventions were acceptable and useful for pts but did not improve informed consent comprehension in a highly educated, White, and English-speaking population.
Early-phase oncology trials are complex, and patients(pts) often lack standard treatment options. Prior research has shown that patients’ understanding of clinical trials is suboptimal.
Researchers aimed to test whether enhanced informed consent can help pts understand clinical trials better.
Pts eligible to participate in one of four investigator-initiated early-phase oncology clinical trials at the Royal Marsden Drug Development Unit were randomized to either a control or experimental arm stratified by age and educational level. The control arm received the full-length trial PIS, followed by electronic or paper administration of the Quality of Informed Consent Questionnaire Parts A (QuIC-A). The experimental arm received the full-length trial PIS, exposure to a two-page study-specific aid, and 10 online educational videos (both co-designed with patients and clinicians), followed by administration of the QuIC-A. The primary endpoint was the difference in the QuIC-A score between the control and experimental arm. The accrual target was at least 17 evaluable pts per arm to detect an 8-point difference (80% power, alpha 0.05).
About 45 pts were involved in the study, 17 in the control arm and 18 in the experimental arm, all of whom completed the QuIC-A. Most pts were over 65 (38%), identified as White (91%), had a university degree (56%), and spoke English at home (97%). There was no significant improvement in the primary endpoint for evaluable patients: control arm (QuIC-A score of 76.5/100) versus experimental arm (QuIC-A – 77.4/100), with a P-value of 0.39 (one-sided, two-sample t-test). Additionally, 20 participants provided feedback on the enhanced consent materials, with 75% reporting no distress or discomfort and 85% finding them quite useful or very useful.
The study showed that online communication interventions were acceptable and useful for pts but did not improve informed consent comprehension in a highly educated, White, and English-speaking population. Future studies should focus on groups with lower literacy and from culturally and linguistically diverse backgrounds.
Source: https://ascopubs.org/doi/abs/10.1200/JCO.2023.41.16_suppl.6560
Clinical Trial: https://www.clinicaltrials.gov/study/NCT04407676
Abhijit Pal, Robert Daly, Sarah Stapleton, Christina Yap, Martin Hong, Rafael Grochot, Shybi MohamedKhan, Julia Elizabeth Lai-Kwon, Dimitrios Magkos, Bindumalini Rao Baikady, Anna Rachel Minchom, Udai Banerji, Johann S. De Bono, Deme John Karikios, Frances M. Boyle, and Juanita Suzanne Lopez. DOI: 10.1200/JCO.2023.41.16_suppl.6560 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 6560-6560.
