Cancer clinical trials are essential for testing the safety and efficacy of promising treatments and translating new knowledge into tangible benefits for patients; they also represent state-of-the art treatment for individuals with cancer. However, only a small proportion of people with cancer ever enroll in a trial. Under-enrollment is a greater problem among minorities, particularly African Americans, suggesting a healthcare disparity and limiting the generalizability of findings across populations.[1, 2]
Barriers to clinical trial enrollment exist at every level.[3, 4] Still, most efforts to increase enrollment focus on patients’ and community members’ awareness, knowledge, and attitudes related to clinical trials.[5-8] Other efforts focus on system-level factors, such as increasing the number of available trials, providing resources to under-resourced medical institutions, and broadening eligibility criteria. However, one barrier that has received relatively little attention is physician communication during clinical interactions with patients who are potentially eligible for an available trial.
Studies show that most patients, if eligible for an available trial, agree to participate when their physician offers them the opportunity and explicitly recommends they consider participating using clear, patient-centered communication.[10-12] Unfortunately, oncologists infrequently discuss trials with their eligible patients[13, 10] due to a lack of awareness of available trials, negative attitudes about the time and resources required to discuss and enroll patients in trials, negative beliefs about the scientific value of trials, and perceptions that their patients are not interested in participating. When oncologists do discuss trials with eligible patients, they often use confusing or misleading language, such as omitting key aspects of the trial (e.g., the purpose of the study), exaggerating benefits, and minimizing risks. Also, the quality of clinical communication (including communication about clinical trials) has been shown to be poorer during interactions with African-American patients than in those with White patients. Our own observational research has demonstrated that when African Americans are invited to participate in a trial, they receive less information about the trial than White patients.
Existing interventions to improve awareness, attitudes, knowledge, and communication skills related to patient-physician discussions about trials have several limitations. First, most interventions focus on the communication skills of patients, rather than physicians. Second, physician communication training in the oncology setting often fails to include content specific to discussing clinical trials or about discussing trials with racially/ethnically diverse patient populations.[19, 20] Third, physician communication training generally utilizes simulated scenarios rather than naturally-occurring clinical interactions to illustrate skills and facilitate skills practice. Although simulated scenarios can be helpful for illustrating a specific teaching objective, medical trainees often view simulated scenarios as contrived or inauthentic, a view likely to be even stronger among experienced clinicians. Video recordings of naturally-occurring trial discussions collected for research purposes contain rich examples of effective and ineffective strategies oncologists use to manage the challenges of clinical encounters. De-identified, professional re-enactments of these interactions offer naturalistic opportunities for learning and reflection that can be disseminated for training.
We describe the development and pilot-testing of a web-based physician training module using professional re-enactments of actual clinical interactions. The module was designed as an intervention to improve physicians’ knowledge, beliefs, and attitudes related to discussing cancer clinical trials with patients and their families in a diverse patient population. The pilot test was designed to assess the extent to which the training module improved physicians’ beliefs, knowledge, attitudes, and comfort related to discussing clinical trials with patients and families, as well as to obtain their general feedback on the acceptability of the training module. Findings can inform a future randomized controlled trial to assess the extent to which the intervention improves trial-related communication in clinical settings.
Development of the Training Module
The module was developed by the investigators and stakeholders, including oncologists, survivors, and community members. The module was designed to be accessed via a website, and included a brief didactic video followed by re-enacted clinical interactions in which clinical trials were discussed.
Didactic video: The professionally-produced didactic video included physicians and health communication scientists from two National Cancer Institute-designated comprehensive cancer centers (John Hopkins Sidney Kimmel Cancer Center [JHU] and Wayne State University/Karmanos Cancer Institute [WSU-KCI]). These professionals described the importance of recruiting a diverse population of patients to cancer clinical trials using high-quality, patient-centered communication involving the exchange of informational and relational messages. Informational communication was described as discussing information that patients need to make an informed decision about participating in a specific trial, including the purpose of the trial; risks (including side effects); benefits to the individual and/or society; alternatives to participating in the trial; and that participation in the trial is voluntary. Relational communication was described as using strategies for using clear, effective, patient-centered communication, such as building trust, encouraging questions, using lay language, including family members, making clear transitions between topics, and using “ask-tell-ask” and “teach-back”.[23, 24] (The didactic video received a Silver and a Gold Telly Award in 2020, an award that honors excellence in video and television across all screens.)
Re-enactments: Professional actors re-enacted video-recorded patient-oncologist interactions collected as part of a prior study investigating patient-oncologist communication about clinical trials. The re-enactments illustrated points made in the didactic video and gave physicians an opportunity to observe and reflect on clinical communication that naturally occurred in clinical settings that may be similar to their own practices. To select video segments to re-enact, we identified videos that included an explicit trial offer (n=39). Faces in the videos were blurred to protect confidentiality. A panel of stakeholders (three clinical oncologists, two communication scientists, and three community members) identified portions of the interactions they deemed important for training oncologists to communicate effectively about trials. Based on the expert panel’s recommendations, we selected 13 video segments which clearly demonstrated an oncologist (1) discussing at least one key elements of consent and (2) using particularly high- or low-quality relational communication. These segments were transcribed verbatim to form scripts for the re-enactments. A professional production company produced the re-enactments with actors selected for their skill and for the extent to which their appearance was similar to the patients, family members, and physicians in the original interactions. To increase authenticity, recording of the re-enactments took place in one of the outpatient clinics where the original interactions had occurred and were recorded using similar equipment.
Following production, stakeholders (9 oncologists and 10 cancer survivors) viewed the re-enactments to judge the extent to which they were informative, realistic, and valuable for training oncologists, and the extent to which physicians in the re-enactments used lay language, clear and easy explanations, were informative and thorough, and seemed to care about the patients. Stakeholder judgements were favorable on all items and thus all of the re-enactments were included in the training module along with open-ended questions to encourage physicians to reflect on their own communication skills.
Pilot-Testing of the Training Module
Setting, Participants, and Procedures
The goal of the pilot test was to assess the extent to which the training module improved physicians’ beliefs, attitudes, knowledge, and comfort related to discussing clinical trials with patients and families, as well as to obtain their general feedback on the acceptability of the training module. Physicians participating in a larger study designed to improve clinical trial communication and accrual rates among Black and White men with prostate cancer were eligible and invited to complete the module. The larger study was conducted at two National Cancer-Institute-designated comprehensive cancer centers, one in Detroit, Michigan (WSU/KCI) and the other in Baltimore, Maryland (JHU). Briefly, for the larger study, patient participants received a patient-focused intervention via a between-subjects design (Phases 1 and 2), and physician participants received the training module as part of a physician-focused intervention two years into the study via a within-subjects design (Phase 2). From February-November, 2019, physician participants were provided a link to access the module online and given two weeks to complete it. All procedures were approved by the institutional review boards at both hospitals and universities.
Assessments: Unless otherwise indicated, participants completed items at the beginning and/or end of the module to assess the following:
Sociodemographic and professional characteristics included clinical specialty, years in practice, practice site, gender, race/ethnicity, and age.
Greatest perceived barrier to clinical trial offers was indicated with choice of one among the following options: lack of available trials, lack of institutional support, lack of awareness of available trials, or belief that patients prefer not to discuss trials.
Beliefs about clinical trials were assessed with a 13-item measure of beliefs about three dimensions of clinical trials: patient care (e.g., “Clinical trials improve patient care in general”);” profession (e.g., “Clinical trials are an appropriate use of resources”; and available resources (e.g., “Information about clinical trials is easily available to me”). Responses ranged from 1= strongly disagree to 5=strongly agree.
Behavioral attitudes towards clinical trials were assessed with 6 semantic differential items (i.e., unpleasant – pleasant; harmful – beneficial; not enjoyable – enjoyable; worthless – valuable; not preferable – preferable; useless - useful) beginning with the stem: “Offering a clinical trial to my eligible patients with prostate cancer would be…” Responses were rated on a 5-point scale.
Knowledge of trial-related information and communication skills that should be used during clinical trials discussions with patients was assessed with 11 items in multiple choice or true-false formats. Some examples were “Which of the following best describes the “teach-back” method of communicating with patients?” and “As long as the purpose section of a clinical trial’s informed consent form is full and complete, there is no reason to tell the patient that the trial is research.”
Comfort with discussing clinical trials was assessed with 1 item (“I am comfortable discussing clinical trials with my patients,”) with responses ranging from 1=strongly disagree to 5=strongly agree.
Course Evaluation: Participants were asked to evaluate three aspects of the course. The didactic video evaluation, presented following the video, included 6 items, (e.g., “The contents of this video will be valuable in discussing clinical trials with my patients and their families”). The re-enactments evaluation, presented following the re-enactments, used the same six items used to evaluate the didactic video plus two additional items, (“There was too much new information” and “I enjoyed the (reenactment) videos”). All responses ranged from 1=strongly disagree to 5=strongly agree. Finally, at the end of the module, 3 questions assessed the extent to which the course achieved its objectives (e.g., “Learners will be able to identify strategies for discussing trials with patients and families”; responses ranged from 1 [not well at all] to 5 [very well]), and one question assessed whether physicians would make changes in their practice based on what they learned in the course (yes/no). Participants were also asked to provide general comments and/or suggestions for future activities.