Clinical trials are essential for developing new and effective treatments and improving patient quality of life; however, many trials cannot answer their primary research questions because they fall short of their recruitment goals. This article reports the results of formative research conducted in two populations, the public and primary care physicians, to identify messages that may raise awareness and increase interest in clinical trials and be used in a national communication campaign. Results suggested that participants were primarily motivated to participate in clinical trials out of a self-interest to help themselves first. Messages illustrated that current treatments were tested via clinical trials, helped normalize trials as routine practices, and reduced concerns over trying something new first. Participants wanted messages that portray trials as state-of-the-art choices that offer some hope, show people like themselves, and are described in a clear, concise manner with actionable steps for them to take. The study revealed some differences in message salience, with healthy audiences exhibiting lower levels of interest. Our results suggest that targeted messages are needed, and that communication with primary health-care providers is an important and necessary component in raising patient awareness of the importance of clinical trials.

Since 1998, the National Cancer Institute (NCI) has mandated that researchers use its consent form template in developing consent forms for their NCI-funded clinical trials. The template was substantially revised in 2013 to aid in the development of simpler, more concise consent forms. The NCI conducted a randomized controlled trial with cancer survivors (N = 153) to assess the revised template's effect on individuals' knowledge, satisfaction, clarity, and likelihood of joining a trial in the future. We found that the revised template resulted in equally high knowledge and satisfaction scores as the original template, but with fewer words and pages. The likelihood that an individual would participate in a trial diminished after he or she reviewed either the original or revised consent form, yet having knowledge about trials before reviewing the consent forms resulted in increased satisfaction. To ensure an informed decision-making process, we recommend using the revised NCI consent form template along with using educational interventions aimed at increasing the understanding potential participants have of a trial before they receive a consent form.

6537 Background: Two major barriers to patient clinical trial (CT) participation are lack of awareness of CTs and limited communication from physicians about available trials. Many call for a national communication campaign to increase public and physician awareness and interest in CTs. We present the results of a national survey assessing the impact of multiple message CT concept ads on individuals and primary care physicians (PCPs). Methods: National online survey in 2011 with PCPs (N = 171) and 3 categories of adults in the general public (healthy; ill with a serious chronic disease; or a caregiver; N = 541; oversampled for cancer). Individuals viewed 3 of 4 novel ads promoting CTs. Questions assessed attitudes and understanding of CTs, reactions to ads, and intentions to participate in (public) or recommend (PCPs) CTs before and after seeing the ads. Results: Prior to seeing ads, 65% of the public only had a general sense of CTs and 12% knew very little or nothing; only 36% said they were likely to consider a CT in the future. Top reasons to consider CTs were if earlier treatment did not work (64%) or their doctor recommended it (60%). Of PCPs, 59% said they were likely to suggest patients consider CTs. All ad concepts were rated positively ( = 3.7 to 4.3; 1 = very neg; 5 = very pos); though some were better received. Top strengths of ads were their appeal to the value of CTs and that “people like them” were in CTs; PCPs liked that viewers were encouraged to “talk with their doctors.” However, some responses differed across groups in the general public. After seeing the ads, the likelihood by the public to consider a CT nearly doubled (from 36% to 64%, p < .001) and 84% (increase by 25%, p < .001) of PCPs said they were likely to suggest CTs to patients. Conclusions: In general, ads were well received by all respondents and significantly increased the public’s consideration of CTs and PCPs’ likelihood of recommending CTs. The ads demonstrated the value of CTs, normalized CT participation, and proposed acceptable calls to action to talk with doctors and visit websites for more information. However, initial awareness of CTs is very low; any campaign would need to clearly and simply convey what a clinical trial is and care should be taken in selecting well-received ad concepts.

6523 Background: In 1997, the National Cancer Institute (NCI) began using a standardized template to develop Informed Consent Documents (ICD) for its clinical trials. NCI recently revised the template based on expert input from five working groups to reduce its complexity and length. We report findings from a study comparing the application of the original and the revised, concise template to a Phase 3 colon cancer treatment trial. Methods: Two ICDs for the same trial were compared using a randomized, controlled design. Participants were randomly assigned to Group 1 (the control) which reviewed the original ICD (O-ICD) or Group 2, which reviewed the concise ICD (C-ICD). We hypothesized that viewing the C-ICD would result in higher knowledge and satisfaction scores than viewing the O-ICD. Participants’ likelihood to consider a clinical trial (CT) after seeing the ICD was assessed. Participants were adult colorectal cancer survivors who completed treatment in the past 10 years and had never taken part in a CT. Pre- and post-test responses were collected via an online survey. Results: The groups (O-ICD, N=72; C-ICD, N=81) did not differ on age, gender, education, income or prior CT knowledge. No group differences were found on number of knowledge items correct (O-ICD: avg=20.3/24 total; C-ICD: avg=21/24; p=.20) or satisfaction (O-ICD: avg=4.23/5.0; C-ICD: avg=4.16/5; p=.23 [1 low; 5 high]). Higher education predicted greater number correct (p=.04). Less education and more prior CT knowledge predicted higher satisfaction with the ICDs (p=.01). All respondents reported lower intentions to participate in a CT after viewing the ICDs. Conclusions: The C-ICD’s format applied plain language principles and was shorter by two pages (11 vs. 13 pgs for O-ICD). Although the C-ICD did not prove superior, it maintained high knowledge and satisfaction scores similar to the O-ICD. This study allowed unlimited time to read the ICDs and did not carry the same emotional implication as an actual CT situation where brevity may have greater impact. Finally, education about CTs appears beneficial as those reporting prior CT knowledge had significantly increased satisfaction scores and were more likely to consider a clinical trial in the future.