Phase II Trial of Concurrent Nivolumab and Radiation Therapy for Muscle-Invasive Bladder Cancer of Older or Chemotherapy-Ineligible Patients.

PURPOSE: Bladder cancer is predominantly a disease of older individuals. Concurrent chemotherapy and radiation is a bladder-sparing strategy for management of muscle-invasive bladder cancer; however, many patients are not candidates for chemotherapy due to comorbidities or impaired performance status. We conducted a study in a chemotherapy-ineligible patient population with the objectives of evaluating the safety, efficacy, and quality-of-life effect of the combination of nivolumab and radiation therapy in patients with localized/locally advanced urothelial cancer. METHODS AND MATERIALS: Eligible patients had muscle-invasive bladder cancer and were not candidates for standard chemoradiation strategy due to at least one of the following: performance status of 2, creatinine clearance ≤60 mL/min, cardiac disease, neuropathy, and intolerance to previous treatment. Creatinine clearance ≥40 mL/min, normal marrow, and liver function were required. The primary endpoint was progression-free survival at 12 months. Nivolumab was started within 3 days of radiation therapy and administered at a dose of 240 mg intravenously every 2 weeks for a maximum of 6 months. Radiation therapy was per standard of care for bladder cancer. Imaging and cystoscopy and biopsy evaluation were required at months 3, 6, and 12 and then annually until progression. RESULTS: Twenty patients were enrolled, with a median age of 78.5 years (range, 58-95 years); 80% of patients were >70 years of age, and 8 (40%) were >80 years of age. Median creatinine clearance was 52 mL/min. Nine patients (48%) were progression free at 12 months. Median progression-free survival was 11.4 months (90% CI, 7.5-23.7 months), and median overall survival was 15.6 months (90% CI, 9.1-26.1 months). CONCLUSIONS: Concurrent nivolumab and radiation therapy is tolerable but demonstrated limited efficacy in an older population with multiple comorbidities. Immune correlates demonstrated that patients with baseline programmed cell death ligand 1 combined prognostic score ≥5% had numerically longer progression-free survival.

Using Music as a Tool for Distress Reduction During Cancer Chemotherapy Treatment.

PURPOSE: Music may be an effective therapeutic tool during cancer treatment to improve patient psychological and physical well-being. Current research shows a positive effect of music on psychological outcomes; however, many of these studies lacked significant sample size and rigor in monitoring type of music used and duration of music use during treatment. METHODS: Participants (N = 750) in this open-label, multisite, day-based permuted block randomization study were adult patients receiving outpatient chemotherapy infusion. Patients were randomly assigned to either music (listen to music for up to 60 minutes) or control (no music) conditions. Music patients were allowed to self-select an iPod shuffle programmed with up to 500 minutes of music from a single genre (eg, Motown, 60s, 70s, 80s, classical, and country). Outcomes were self-reported change in pain, positive and negative mood, and distress. RESULTS: Patients who listened to self-selected music during infusion showed significant benefit in improved positive mood and reduced negative mood and distress (but not pain) from pre- to post-intervention (all two-sample t-tests P < .05). LASSO penalized linear regression models showed a selective benefit for some patients on the basis of relationship (P = .032) and employment (P = .029) status with those who were married or widowed and those on disability showing better outcomes. CONCLUSION: Music medicine is a low-touch, low-risk, and cost-effective way to manage patients' psychological well-being in the often stressful context of a cancer infusion clinic. Future research should be directed to understanding what other factors may mitigate negative mood states and pain for certain groups during treatment.

Ask questions (ASQ): Implementation of a question prompt list communication intervention in a network of outpatient medical oncology clinics.

OBJECTIVE: This descriptive, single-arm study assessed the implementation and patient perceptions of an evidence-based Question Prompt List (QPL), the ASQ brochure, across a network of oncology clinics in a diverse patient population. METHOD: The QPL was revised in collaboration with stakeholders. Implementation was assessed using the RE-AIM framework. Eligible patients were scheduled for a first appointment with an oncologist at any of eight participating clinics. All participants received the ASQ brochure and completed three surveys: one at baseline, one immediately before, and one following their appointment. Surveys assessed sociodemographic characteristics; communication-related outcomes (perceived knowledge, self-efficacy in interacting with physicians, trust in physicians, distress); and perceptions of the ASQ brochure. Analyses included descriptive statistics and linear mixed-effects models. RESULTS: Reach: Participants (n = 81) represented the diverse population served by the clinic network. EFFICACY: All outcomes improved significantly, with no significant differences by clinic site or patient race. Adoption: All eight invited clinics participated and recruited patients. Patient perceptions of the ASQ brochure were overwhelmingly positive. CONCLUSION: Implementation of the ASQ brochure was successful in this oncology clinic network providing care to a diverse patient population. PRACTICAL IMPLICATIONS: This evidence-based communication intervention can be implemented widely in similar medical contexts and populations.

Development and pilot test of a physician-focused cancer clinical trials communication training intervention.

Objective: We describe the development and pilot test of a physician-focused, web-based training module designed to improve physician communication related to clinical trials in a diverse cancer patient population. Methods: Researchers and stakeholders developed the training module, which included a video explaining patient-centered communication strategies for discussing trials, and re-enactments of actual clinical interactions. For the pilot test, the module was provided to physician participants in the Partnering Around Cancer Clinical Trials (PACCT) trial at two major urban cancer centers. Questionnaires assessed change in beliefs, behavioral attitudes, knowledge and comfort; and perceptions of the module. Results: Nineteen physicians participated in the pilot test. Most were experienced in discussing trials. Assessments of change were mixed regarding beliefs; they showed marginal improvement in attitudes, and significant improvement in knowledge, but no change in comfort. Feedback on the module was favorable. Conclusions: This stakeholder-developed physician communication training module was acceptable and effective, albeit in this small and highly-experienced physician sample. Future research should determine its effectiveness on communication in clinical settings. Innovation: This is the first physician training module to focus on communicating about clinical trials in a diverse patient population. It offers a web-based format and re-enactments of naturally-occurring clinical interactions.Trial Registration Number: NCT02906241.

Characterizing patient-oncologist communication in genomic tumor testing: The 21-gene recurrence score as an exemplar.

OBJECTIVE: Women with early-stage, ER + breast cancer are recommend to receive genomic profiling tests, such as the 21-gene Recurrence Score (RS) test, to guide treatment decisions. We examined test- and treatment-related information discussed and the associations between RS categories and aspects of communication during patient-oncologist clinical encounters. METHODS: As part of a larger trial, clinical encounters (N = 46) were audiorecorded and coded for 1) RS- and treatment-related information, 2) shared decision making, 3) patient active participation, and 4) oncologist patient-centered communication. We examined differences by RS category using mixed models, adjusting for nesting within oncologist. RESULTS: Patients with a high RS were more likely to receive a chemotherapy recommendation (p < .01), hear about the risks/side effects of chemotherapy (p < .01), and offer their preferences (p = .02) than those with intermediate or low RS. Elements of shared decision making increased with RS. Oncologist patient-centered communication (M = 4.09/5, SD = .25) and patient active participation (M = 3.5/4, SD = 1.0) were high across RS. CONCLUSION: Findings suggest that disease severity, rather than clinical uncertainty, impact treatment recommendations and shared decision making. PRACTICE IMPLICATIONS: Oncologists adjust test- and treatment-related information and shared decision making by disease severity. This information provides a framework to inform decision making in complex cancer and genomics settings.

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.

The influence of a question prompt list on patient-oncologist information exchange in an African-American population.

OBJECTIVES: Question Prompt Lists (QPL) increase patient active participation in oncology interactions, but questions remain regarding how QPLs influence patient-oncologist information exchange. We examined how a QPL influenced information exchange during oncology interactions with African-American patients. METHODS: Data were self-reports and video recordings from a parent study testing the effects of a QPL in the outpatient clinics of two urban cancer hospitals. In this secondary analysis, we investigated which QPL questions patients identified as ones they wanted to ask their oncologists, how frequently patients/companions used patient active participation statements to seek information related to each QPL question, whether oncologists provided QPL-related information unprompted or prompted by patients/companions, and how frequently patients' QPL-related information needs were addressed or unaddressed. RESULTS: The QPL influenced information exchange by increasing patients' and companions' (if present) prompting for QPL-related information from their oncologists. Patients/companions most often prompted for QPL-related information about side effects and patient experience. CONCLUSION: This study builds on prior research on QPL interventions by expanding the object of study to information exchange and by analyzing patients' information needs. PRACTICE IMPLICATIONS: This research demonstrates that a QPL supports patient/companion participation in oncology consultations by making information exchange more interactive.