Addressing multilevel barriers to clinical trial participation among Black and White men with prostate cancer through the PACCT study.

BACKGROUND: Cancer clinical trial participation is low and inequitable. Partnering Around Cancer Clinical Trials (PACCT) addressed systemic and interpersonal barriers through an observational study of eligibility and an intervention to improve patient-physician communication and trial invitation rates. METHODS: Physicians at two comprehensive cancer centers and Black and White men with prostate cancer participated. Patients were followed for 2 years to determine whether they became potentially eligible for an available therapeutic trial. Potentially eligible patients were randomized to receive a trials-focused Question Prompt List or usual care. Patient-physician interactions were video-recorded. Outcomes included communication quality and trial invitation rates. Descriptive analyses assessed associations between sociodemographic characteristics and eligibility and effects of the intervention on outcomes. RESULTS: Only 44 (22.1%) of participating patients (n = 199) became potentially eligible for an available clinical trial. Patients with higher incomes were more often eligible (>$80,000 vs. <$40,000, adjusted OR = 6.06 [SD, 1.97]; $40,000-$79,000 vs. <$40,000, adjusted OR = 4.40 [SD, 1.81]). Among eligible patients randomized to the intervention (n = 19) or usual care (n = 25), Black patients randomized to the intervention reported participating more actively than usual care patients, while White intervention patients reported participating less actively (difference, 0.41 vs. -0.34). Intervention patients received more trial invitations than usual care patients (73.7% vs. 60.0%); this effect was greater for Black (80.0% vs. 30.0%) than White patients (80.0% vs. 66.7%). CONCLUSIONS: Findings suggest the greatest enrollment barrier is eligibility for an available trial, but a communication intervention can improve communication quality and trial invitation rates, especially for eligible Black patients.

Nonverbal Synchrony: An Indicator of Clinical Communication Quality in Racially-Concordant and Racially-Discordant Oncology Interactions.

OBJECTIVES: The aim of this cross-sectional study was to apply a novel software to measure and compare levels of nonverbal synchrony, as a potential indicator of communication quality, in video recordings of racially-concordant and racially-discordant oncology interactions. Predictions include that the levels of nonverbal synchrony will be greater during racially-concordant interactions than racially-discordant interactions, and that levels of nonverbal synchrony will be associated with traditional measures of communication quality in both racially-concordant and racially-discordant interactions. DESIGN: This is a secondary observational analysis of video-recorded oncology treatment discussions collected from 2 previous studies. SETTING: Two National Cancer Institute-designated Comprehensive Cancer Centers and another large urban cancer center. PARTICIPANTS: Participants from Study 1 include 161 White patients with cancer and 11 White medical oncologists. Participants from Study 2 include 66 Black/African-American patients with cancer and 17 non-Black medical oncologists. In both studies inclusion criteria for patients was a recent cancer diagnosis; in Study 2 inclusion criteria was identifying as Black/African American. MAIN OUTCOME MEASURES: Nonverbal synchrony and communication quality. RESULTS: Greater levels of nonverbal synchrony were observed in racially-discordant interactions than in racially-concordant interactions. Levels of nonverbal synchrony were associated with indicators of communication quality, and these associations were more consistently found in racially-discordant interactions. CONCLUSION: This study advances clinical communication and disparities research by successfully applying a novel approach capturing the unconscious nature of communication, and revealing differences in communication in racially-discordant and racially-concordant oncology interactions. This study highlights the need for further exploration of nonverbal aspects relevant to patient-physician interactions.

Willingness to Discuss Clinical Trials Among Black vs White Men With Prostate Cancer.

IMPORTANCE: Black individuals are underrepresented in cancer clinical trials. OBJECTIVE: To examine whether Black and White men with prostate cancer differ in their willingness to discuss clinical trials with their physicians and, if so, whether patient-level barriers statistically mediate racial differences. DESIGN, SETTING, AND PARTICIPANTS: This cross-sectional survey study used baseline data from Partnering Around Cancer Clinical Trials, a randomized clinical trial to increase Black individuals' enrollment in prostate cancer clinical trials. Data were collected from 2016 through 2019 at 2 National Cancer Institute-designated comprehensive cancer centers; participants were Black and White men with intermediate-risk to high-risk prostate cancer. In mediation analysis, path models regressed willingness onto race and each potential mediator, simultaneously including direct paths from race to each mediator. Significant indirect effect sizes served as evidence for mediation. EXPOSURES: Race was the primary exposure. Potential mediators included age, education, household income, perceived economic burden, pain/physical limitation, health literacy, general trust in physicians, and group-based medical suspicion. MAIN OUTCOMES AND MEASURES: The primary outcome was the answer to a single question: "If you were offered a cancer clinical trial, would you be willing to hear more information about it?" RESULTS: A total of 205 participants were included (92 Black men and 113 White men), with a mean (range) age of 65.7 (45-89) years; 32% had a high school education or lower, and 27.5% had a household income of less than $40 000. Most (88.3%) reported being definitely or probably willing to discuss trials, but White participants were more likely to endorse this highest category of willingness than Black participants (82% vs 64%; χ22 = 8.81; P = .01). Compared with White participants, Black participants were younger (F1,182 = 8.67; P < .001), less educated (F1,182 = 22.79; P < .001), with lower income (F1,182 = 79.59; P < .001), greater perceived economic burden (F1,182 = 42.46; P < .001), lower health literacy (F1,184 = 9.84; P = .002), and greater group-based medical suspicion (F1,184 = 21.48; P < .001). Only group-based medical suspicion significantly mediated the association between race and willingness to discuss trials (indirect effect, -0.22; P = .002). CONCLUSIONS AND RELEVANCE: In this study of men with prostate cancer, most participants were willing to discuss trials, but Black men were significantly less willing than White men. Black men were more likely to believe that members of their racial group should be suspicious of the health care system, and this belief was associated with lower willingness to discuss trials. Addressing medical mistrust may improve equity in clinical research.

Partnering around cancer clinical trials (PACCT): study protocol for a randomized trial of a patient and physician communication intervention to increase minority accrual to prostate cancer clinical trials.

BACKGROUND: Cancer clinical trials are essential for testing new treatments and represent state-of-the-art cancer treatment, but only a small percentage of patients ever enroll in a trial. Under-enrollment is an even greater problem among minorities, particularly African Americans, representing a racial/ethnic disparity in cancer care. One understudied cause is patient-physician communication, which is often of poor quality during clinical interactions between African-American patients and non-African-American physicians. Partnering Around Cancer Clinical Trials (PACCT) involves a transdisciplinary theoretical model proposing that patient and physician individual attitudes and beliefs and their interpersonal communication during racially discordant clinical interactions influence outcomes related to patients' decisions to participate in a trial. The overall goal of the study is to test a multilevel intervention designed to increase rates at which African-American and White men with prostate cancer make an informed decision to participate in a clinical trial. METHODS/DESIGN: Data collection will occur at two NCI-designated comprehensive cancer centers. Participants include physicians who treat men with prostate cancer and their African-American and White patients who are potentially eligible for a clinical trial. The study uses two distinct research designs to evaluate the effects of two behavioral interventions, one focused on patients and the other on physicians. The primary goal is to increase the number of patients who decide to enroll in a trial; secondary goals include increasing rates of physician trial offers, improving the quality of patient-physician communication during video recorded clinical interactions in which trials may be discussed, improving patients' understanding of trials offered, and increasing the number of patients who actually enroll. Aims are to 1) determine the independent and combined effects of the two interventions on outcomes; 2) compare the effects of the interventions on African-American versus White men; and 3) examine the extent to which patient-physician communication mediates the effect of the interventions on the outcomes. DISCUSSION: PACCT has the potential to identify ways to increase clinical trial rates in a diverse patient population. The research can also improve access to high quality clinical care for African American men bearing the disproportionate burden of disparities in prostate and other cancers. TRIAL REGISTRATION: Clinical Trials.gov registration number: NCT02906241 (September 8, 2016).

Do Patients and Oncologists Discuss the Cost of Cancer Treatment? An Observational Study of Clinical Interactions Between African American Patients and Their Oncologists.

PURPOSE: Financial toxicity negatively affects patients with cancer, especially racial/ethnic minorities. Patient-oncologist discussions about treatment-related costs may reduce financial toxicity by factoring costs into treatment decisions. This study investigated the frequency and nature of cost discussions during clinical interactions between African American patients and oncologists and examined whether cost discussions were affected by patient sociodemographic characteristics and social support, a known buffer to perceived financial stress. Methods Video recorded patient-oncologist clinical interactions (n = 103) from outpatient clinics of two urban cancer hospitals (including a National Cancer Institute-designated comprehensive cancer center) were analyzed. Coders studied the videos for the presence and duration of cost discussions and then determined the initiator, topic, oncologist response to the patient's concerns, and the patient's reaction to the oncologist's response. RESULTS: Cost discussions occurred in 45% of clinical interactions. Patients initiated 63% of discussions; oncologists initiated 36%. The most frequent topics were concern about time off from work for treatment (initiated by patients) and insurance (initiated by oncologists). Younger patients and patients with more perceived social support satisfaction were more likely to discuss cost. Patient age interacted with amount of social support to affect frequency of cost discussions within interactions. Younger patients with more social support had more cost discussions; older patients with more social support had fewer cost discussions. CONCLUSION: Cost discussions occurred in fewer than one half of the interactions and most commonly focused on the impact of the diagnosis on patients' opportunity costs rather than treatment costs. Implications for ASCO's Value Framework and design of interventions to improve cost discussions are discussed.

Measuring the use of examination room time in oncology clinics: a novel approach to assessing clinic efficiency and patient flow.

PURPOSE: The use of time in outpatient cancer clinics is a marker of quality and efficiency. Inefficiencies such as excessive patient wait times can have deleterious effects on clinic flow, functioning, and patient satisfaction. We propose a novel method of objectively measuring patient time in cancer clinic examination rooms and evaluating its impact on overall system efficiency. METHODS: We video-recorded patient visits (N = 55) taken from a larger study to determine patient occupancy and flow in and out of examination rooms in a busy urban clinic in a National Cancer Institute-designated comprehensive cancer center. Coders observed video recordings and assessed patient occupancy time, patient wait time, and physician-patient interaction time. Patient occupancy time was compared with scheduled occupancy time to determine discrepancy in occupancy time. Descriptive and correlational analyses were conducted. RESULTS: Mean patient occupancy time was 94.8 minutes (SD = 36.6), mean wait time was 34.9 minutes (SD = 28.8), and mean patient-physician interaction time was 29.0 minutes (SD = 13.5). Mean discrepancy in occupancy time was 40.3 minutes (range, 0.75 to 146.5 minutes). We found no correlation between scheduled occupancy time and patient occupancy time, patient-physician interaction time, and patient wait time, or between discrepancy in occupancy time and patient-physician interaction time. CONCLUSION: The method is useful for assessing clinic efficiency and patient flow. There was no relationship between scheduled and actual time patients spend in exam rooms. Such data can be used in the design of interventions that reduce patient wait times, increase efficient use of resources, and improve scheduling patterns.

Variation in question asking during cancer clinical interactions: a potential source of disparities in access to information.

OBJECTIVE: to investigate whether patient demographic characteristics and patients' companions influence variation in patient question asking during cancer clinical interactions, thus representing a potential disparity in access to information. METHODS: data included 109 oncologist-patient-companion interactions video recorded at a comprehensive cancer center. Interactions were observed and analyzed using the Karmanos Information Seeking Analysis System (K-ISAS). RESULTS: significant relationships were found between patient race/ethnicity and question asking. Black patients asked fewer questions and a smaller proportion of direct questions (relative to the total frequency of questions) than White patients. Black patients were also less likely to have companions present during the interaction, which resulted in fewer questions asked on Black patients' behalf. CONCLUSION: differences in question asking by Black and White patients suggest that Black patients may receive less information from their oncologists than White patients. PRACTICE/RESEARCH IMPLICATIONS: patients should be encouraged to ask more questions and more direct questions and to bring a companion to the interaction to assist them in gaining information from their physician. Future research is needed to investigate ways to eliminate this potential source of disparities in access to information.

Influence of clinical communication on patients' decision making on participation in clinical trials.

PURPOSE: To investigate how communication among physicians, patients, and family/companions influences patients' decision making about participation in clinical trials. PATIENTS AND METHODS: We video recorded 235 outpatient interactions occurring among oncologists, patients, and family/companions (if present) at two comprehensive cancer centers. We combined interaction analysis of the real-time video-recorded observations (collected at Time 1) with patient self-reports (Time 2) to determine how communication about trial offers influenced accrual decisions. RESULTS: Clinical trials were explicitly offered in 20% of the interactions. When offers were made and patients perceived they were offered a trial, 75% of patients assented. Observed messages (at Time 1) directly related to patients' self-reports regarding their decisions (2 weeks later), and how they felt about their decisions and their physicians. Specifically, messages that help build a sense of an alliance (among all parties, including the family/companions), provide support (tangible assistance and reassurance about managing adverse effects), and provide medical content in language that patients and family/companions understand are associated with the patient's decision and decision-making process. CONCLUSION: In two urban, National Cancer Institute-designated comprehensive cancer centers, a large percentage of patients are not offered trials. When offered a trial, most patients enroll. The quality and quantity of communication occurring among the oncologist, patient, and family/companion when trials are discussed matter in the patient's decision-making process. These findings can help increase physician awareness of the ways that messages and communication behaviors can be observed and evaluated to improve clinical practice and research.

Communication and consumer decision making about cancer clinical trials.

Communication between patients and physicians likely mediates traditional patient and physician predispositions in determining patient outcomes, including perceptions and decision making. However, the extent to which a mediating effect occurs is unclear. The purpose of this essay is to outline the need for conceptualizing more holistic models of consumer-provider interaction that demonstrate the role of the therapeutic relationship in treatment outcomes. We focus on an important communicative context for exploring this question: the situation where patients, with the help of oncologists, are faced with making treatment choices, particularly whether to enroll in a clinical trial in response to their life-threatening cancer diagnosis. We explore the question from the perspectives of the medical provider, the patient, and the accompanying family member, in order to better frame the complex interactional dynamics occurring during the interaction.