As reported in JCO Oncology Practice by Roth et al, many participants in a biomarker-driven master protocol trial (Lung Cancer Master Protocol [Lung-MAP]; SWOG S1400GEN) did not display correct knowledge or expectations about using the results of genomic testing.
Study Details
Lung-MAP is a National Clinical Trials Network biomarker-driven master protocol designed to evaluate biomarker-driven therapies in biomarker-defined subgroups of patients with previously treated advanced non–small cell lung cancer (NSCLC).
The current study included 207 Lung-MAP participants with previously treated advanced NSCLC recruited between August 2017 and June 2019. Patients completed a 38-item telephone survey ≤ 30 days from Lung-MAP consent that assessed understanding of the benefits and risks of Lung-MAP participation, as well as knowledge regarding the potential uses of somatic testing results.
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Key Findings
In response to the survey statement “I received enough information about the genetic testing in Lung-MAP trial to understand the benefits … of enrolling in the study,” 82.6% of patients “strongly” or “somewhat” agreed with the statement, 10.1% “strongly” or “somewhat” disagreed, and 7.2% neither agreed nor disagreed.
In response to the statement “I received enough information about the genetic testing in Lung-MAP trial to understand the risks … of enrolling in the study,” 69.5% “strongly” or “somewhat” agreed with the statement, 18.7% “strongly” or “somewhat” disagreed, and 11.8% neither agreed nor disagreed.
In response to the statement “the Lung-MAP study doctors are looking at genetic changes in your tumor cells to help select your cancer treatment,” 87.0% correctly responded “true,” 1.9% incorrectly responded “false,” and 11.1% responded “don’t know.” Participants who agreed with understanding study risks were more likely to provide a correct answer (odds ratio = 2.46, 95% confidence interval = 1.02–5.96).
In response to the statement “the Lung-MAP study doctors are looking at genetic changes in your tumor cells to be sure that you have lung cancer,” 18.8% correctly responded “false,” 58.0% incorrectly responded “true,” and 23.2% responded “don’t know.” Acknowledgment of understanding study benefits was not associated with a correct answer.
In response to the statement “the Lung-MAP study doctors are looking at genetic changes in your tumor cells to find out if you have higher risk of developing a health condition other than cancer,” 13.2% correctly responded “false,” 42.9% incorrectly responded “true,” and 43.9% responded “don’t know.” Acknowledgment of understanding study benefits was not associated with a correct response.
In response to the statement “the Lung-MAP study doctors are looking at genetic changes in your tumor cells to find out if your family members might have an increased risk of developing cancer,” 9.3% correctly responded “false,” 51.2% incorrectly responded “true,” and 39.5% responded “don’t know.” Acknowledgment of understanding study benefits was not associated with correct response.
In both unadjusted and adjusted analyses, none of the sociodemographic factors of age, sex, race, education, or household income was associated with correct responses.
The investigators concluded: “In a large National Clinical Trials Network biomarker-driven master protocol, most participants demonstrated incorrect knowledge and expectations about the uses of genomic results provided in the study, despite most indicating that they had enough information to understand benefits and risks.”
Joshua A. Roth, PhD, MHA, of the Hutchinson Institute for Cancer Outcomes Research, Fred Hutchinson Cancer Research Center, is the corresponding author for the JCO Oncology Practice article.
Disclosure: The study was supported by grants from the National Cancer Institute. For full disclosures of the study authors, visit ascopubs.org.
