The impact of patient education on consideration of enrollment in clinical trials
Background Advances in clinical care depend on well-designed clinical trials, yet the number of adults who enroll is suboptimal.
Objective To evaluate whether providing brief educational material about clinical trials would increase willingness to participate.
Methods From October 23, 2015, through November 12, 2015, 1511 adults in the United States completed an anonymized electronic survey in a single-group, cross-sectional-design study to measure the impression of and willingness to enroll in a hypothetical cancer clinical trial before and after reading brief educational material on the topic.
Results Participants had a worse impression of and were less likely to enroll in a clinical trial before reading the material. Most participants (86.2%) noted that the educational material was believable, easy to understand (84.8%), and included information that was new (81.5%). After reading the material, the overall impression of clinical trials improved (mean standard deviation [SD], 0.42; 95% confidence interval [CI], 0.35-0.50). This improved outlook was greater among participants with a lower level of completed education (Pinteraction < .001). Education level effect was no longer significant after reading the document. Similar results were observed for likeliness of enrolling.
Limitations The study was not randomized, so it is uncertain if the increase in interest and likelihood of enrolling in a clinical trial was solely a result of the intervention; the findings may not be generalizable to a cancer-only cohort, and only English-speaking participants were included.
Conclusion Participants were receptive of educational material and expressed greater interest and likelihood of enrolling in a clinical trial after reading the material. The information had a greater effect on those with less education, but it increased the willingness of all participants to enroll.
Funding/sponsorship Supported in part by the Memorial Sloan Kettering Cancer Center Support Grant P30 CA008748. Julien Mancini was supported through mobility grants from Fondation ARC (SAE20151203703), ADEREM, and Cancéropôle PACA (Mobilités-2015). He has also received funding from the People Programme (Marie Curie Actions) of the European Union's Seventh Framework Programme (FP7/2007-2013) under the REA grant agreement, and he received PCOFUND-GA-2013-609102 through the PRESTIGE Programme coordinated by Campus France.
Accepted for publication April 19, 2018
Correspondence Paul J Sabbatini, MD; sabbatip@mskcc.org
Disclosures The authors report no disclosures/conflicts of interest.
Citation JCSO 2018;16(2):e81-e88
©2018 Frontline Medical Communications
doi https://doi.org/10.12788/jcso.0396
Submit a paper here
Limitations
The lack of randomization makes it difficult to attribute with certainty that the change in acceptability of clinical trial participation is owing to the reading of the educational statement. The survey also sampled only English-speaking and well-educated participants from an online panel (81.1% had at least attended college) despite the use of a weighting procedure to ensure representativeness regarding gender, age, ethnicity, and income. Health literacy level or more specific trial literacy level was not evaluated; however, we were able to show less accurate perceptions of clinical trials among participants with a lower level of education by using agreement toward 8 statements about trials. The responses to hypothetical questions from these participants in the general population may also not be generalizable to a restricted population of patients with cancer. In addition, we measured impression of and willingness to enroll in a clinical trial immediately after providing participants with the educational material. We would have to confirm whether the positive effects of the education persist over time and translate to higher clinical trial participation rates.
,
Conclusions
Participants were receptive of educational material and expressed greater interest in and likelihood of enrolling in a clinical trial after reading it. The information had a greater effect on those with less education, but increased the willingness of all participants to enroll.
