“Older adults with cancer are underrepresented in clinical trials, despite comprising the majority of the patients with cancer,” explains Kelly M. Trevino, PhD. “Patients with cancer are significantly older on average than most clinical trial participants. This age difference reduces the generalizability of clinical trial findings and makes it difficult for clinicians to apply the results of clinical trials to their older adult patients. However, few studies have examined age differences in clinical trial understanding, especially among patients with indolent non-Hodgkin lymphoma (NHL).”

For a paper published in Clinical Lymphoma, Myeloma and Leukemia, Dr. Trevino and colleagues examined the age differences in trial understanding in patients with NHL. They conducted a cross-sectional survey of 74 patients with NHL recruited from a single urban academic medical center. Patients’ understanding of clinical trials goals was assessed with a four-item self-report measure: curing lymphoma, reducing lymphoma, keeping the disease from worsening, and advancing lymphoma research. The response options for each potential goal were “yes,” “no,” and “I don’t know.”

Of the study population, the mean age was 60.4, with 60.8% of patients younger than 65. Most participants were White (97.3%), non-Latinx (95.9%), had a post-graduate education (56.8%), and were employed (75.4%).

 Older Adults Have Less Nuanced Grasp of Clinical Trial Than Younger Adults

The study team found that older adults may have a less nuanced understanding of the objective of a clinical trial than younger adults, says Dr. Trevino. “Patients aged 65 and older were more likely to state that they ‘did not know’ whether clinical trials were designed to reduce lymphoma and prevent the disease from getting worse,” she adds. “However, age differences did not emerge for the clinical trial goals of curing the lymphoma and conducting research (Table).”

Conducting a detailed informed consent process with older adults and checking their understanding of the information during the consent process is particularly important, the researchers note. “Informed consent is a key part of the research process,” Dr. Trevino says. “Ensuring that all patients have a comprehensive and accurate understanding of the methods, possible outcomes, and effects of a clinical trial is critical.”

Older Adults May Benefit from More Detailed Consent Process

 “Prior research suggests that many patients do not understand core features of a trial such as the aim and risks of the trial,” continues Dr. Trevino. “Our study was not conducted in the context of a specific clinical trial and most of the sample had not initiated cancer-directed therapy. However, our findings suggest that older adults may have a lower baseline understanding of the general goals of a clinical trial. Older adults may benefit from a more detailed consent process in which their understanding of the trial is confirmed throughout the informed consent process.”

Dr. Trevino and colleagues acknowledge that this study was a small cross-sectional exploration. “Replication of these findings in larger and more diverse samples is needed,” Dr. Trevino explains. “We were unable to examine the relationship between clinical trial understanding and clinical trial enrollment; longitudinal assessment of the relationship between understanding and enrollment is necessary to determine whether improving clinical trial understanding in older adults may impact clinical trial enrollment. Future research using a validated measure of clinical trial understanding will also provide more robust results.”

 

Author