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.

Physicians' use of plain language during discussions of prostate cancer clinical trials with patients.

OBJECTIVE: This study described physicians' use of plain language during patient-physician cancer clinical trial discussions. METHODS: Video-recorded clinical interactions and accompanying transcripts were taken from a larger study of communication and clinical trials (PACCT). Interactions (n = 25) were selected if they included invitations to participate in a clinical trial. We used descriptive, qualitative discourse analysis, a method that identifies language patterns at or above the sentence level. We first excerpted discussions of clinical trials, then identified instances of plain language within those discussions. Finally, we inductively coded those instances to describe physicians' plain language practices. RESULTS: The analysis identified four plain language practices. Lexical simplification replaced medical terminology with simpler words. Patient-centered definition named, categorized, and explained complex medical terminology. Metaphor explained medical terminology by comparing it with known concepts. Finally, experience-focused description replaced medical terminology with descriptions of patients' potential physical experiences. CONCLUSION: These plain language practices hold promise as part of effective information exchange in discussions of cancer clinical trials. Testing is needed to identify patient preferences and the extent to which these practices address patient health literacy needs. PRACTICE IMPLICATIONS: Pending further testing, these plain language practices may be integrated into physician clinical trial and other communication training.

Impact of Patients' Companions on Clinical Encounters Between Black Patients and Their Non-Black Oncologists.

PURPOSE: The presence of caregivers or companions during clinical encounters influences the dynamics and outcomes of the encounters. Most prior studies of companions in clinical encounters focus on non-Hispanic White patients. However, there is generally lower-quality patient-physician communication during encounters with Black patients; these communication differences may contribute to racial health disparities. The purpose of the present study was to examine effects of the presence and active participation of companions on encounters between Black patients with cancer and non-Black oncologists. METHODS: This was a secondary analysis of data collected during a larger intervention study. Participants were Black patients with breast, colon, or lung cancer who had a treatment-discussion encounter with a participating non-Black medical oncologist. Video recordings of encounters were coded for patient, companion, and oncologist communication. After the encounter, patients reported perceptions of the recommended treatment; patients and oncologists reported perceptions of each other. RESULTS: Data from 114 patients and 19 oncologists were included in analyses. Only 47% of patients brought a companion to the encounter. Oncologists spent more time with accompanied Black patients, used more patient-centered communication with them, and perceived them as having more social support compared with unaccompanied Black patients. Oncologists reported that accompanied patients asked more questions. When companions participated more actively in the encounter, oncologists used more patient-centered communication. DISCUSSION: Bringing a companion to oncology appointments may be beneficial to Black patients because oncologists spend more time with patients, use more patient-centered communication, and perceive patients more positively, all of which may ultimately improve patient health and well-being outcomes.

Preferences for notification of imaging results in patients with metastatic cancer.

OBJECTIVE: This study examines the preferences of patients with metastatic cancer regarding notification of imaging results, as well as distress surrounding the process. METHODS: On imaging day, preferences for notification, expectations of results, health literacy, and social support were measured. After receiving results, patients reported on actual delivery methods. At both times, patients were screened for overall distress, anxiety, and depression. RESULTS: The majority of patients preferred notification within 2 days and during a face-to-face visit with their oncologist. Although levels of distress, anxiety, and depression were low, patients with higher anxiety, depression, and social isolation had higher distress. There was no correlation between absolute distress levels and agreement between notification preferences and actual delivery methods. Receiving results from a preferred provider was associated with a decrease in distress from imaging day to follow-up. Face-to-face delivery of results was more important to people with lower health literacy. CONCLUSIONS: While distress regarding the receipt of results was low, it was higher for some groups of patients. Attending to the preferences of these subgroups may help to minimize distress. PRACTICE IMPLICATIONS: Receiving results from preferred personnel and diminishing patients' sense of social isolation might provide psychological benefit during the period surrounding imaging.

Unpacking Trial Offers and Low Accrual Rates: A Qualitative Analysis of Clinic Visits With Physicians and Patients Potentially Eligible for a Prostate Cancer Clinical Trial.

PURPOSE: Cancer clinical trial accrual rates are low, and information about contributing factors is needed. We examined video-recorded clinical interactions to identify circumstances under which patients potentially eligible for a trial at a major cancer center were offered a trial. METHODS: We conducted a qualitative directed content analysis of 62 recorded interactions with physicians (n = 13) and patients with intermediate- or high-risk prostate cancer (n = 43). Patients were screened and potentially eligible for a trial. We observed and coded the interactions in 3 steps: (1) classification of all interactions as explicit offer, offer pending, trial discussed/not offered, or trial not discussed; (2) in interactions with no explicit offer, classification of whether the cancer had progressed; (3) in interactions classified as progression but no trial offered, identification of factors discussed that may explain the lack of an offer. RESULTS: Of the 62 interactions, 29% were classified as explicit offer, 12% as offer pending, 18% as trial discussed/not offered, and 39% as trial not discussed. Of those with no offer, 57% included information that the cancer had not progressed. In 68% of the remaining interactions with patients whose cancer had progressed but did not receive an offer, reasons for the lack of offer were identified, but in 32%, no explanation was provided. CONCLUSION: Even in optimal circumstances, few patients were offered a trial, often because their cancer had not progressed. Findings support professional recommendations to broaden trial inclusion criteria. Findings suggest accrual rates should reflect the proportion of eligible patients who enroll.