ImportanceThere are few robust evaluations of disease-specific question prompt sheets (QPS) in patient-physician communication among patients with advanced cancer. ObjectiveTo compare the patient perception of helpfulness, global evaluation, and preference for the QPS vs a general information sheet (GIS), and to examine the effect of the QPS on participants' anxiety, participants' speaking time, number of questions asked, and length of the clinical encounter. Design, Setting, and ParticipantsThis controlled, double-blind randomized clinical trial was conducted at an outpatient palliative and supportive care clinic in a cancer center in the US. Eligible patients were 18 years or older, had a cancer diagnosis, and were undergoing their first outpatient consultation visit with a palliative care physician from September 1, 2017, to May 31, 2019. Data analysis used a modified intention-to-treat design. Data were analyzed from May 18 to June 27, 2022. InterventionQPS, a 25-item list of questions developed by expert palliative care clinicians using a Delphi process and tested among ambulatory advanced cancer patients. The control was GIS, generic information material given routinely to patients seen at the supportive care clinic. Main Outcomes and MeasuresThe main outcome was patient perception of helpfulness. Secondary outcomes included global evaluation and preference of QPS compared with GIS immediately after the encounter. ResultsA total of 130 patients (mean [SD] age, 58.6 [13.3] years; 79 [60.8%] female) were randomized to receive either QPS (67 patients [51.5%]) or GIS (63 patients [48.5%]). Patients considered QPS and GIS equally helpful, with no statistically significant difference (mean [SD] helpfulness score, 7.2 [2.3] points vs 7.1 [2.7] points; P=.79). The QPS group, compared with the GIS group, had a higher global positive view of the material (mean [SD] global perception score, 7.1 [1.3] vs 6.5 [1.7]; P=.03) and felt it prompted them more to generate new questions (mean [SD] rating, 7.0 [2.9] vs 5.3 [3.5]; P=.005). Of 47 patients asked their preference between the items, more participants preferred the QPS to the GIS in communicating with their physicians (24 patients [51.1%] vs 7 patients [14.9%]; P=.01) at the 4-week follow-up. No significant differences between the QPS and GIS groups were observed regarding participant anxiety, speaking time, number of questions asked, or consultation length (eg, mean [SD] anxiety rating, 2.3 [3.7] vs 1.6 [2.7]; P=.19). Conclusions and RelevanceIn this randomized clinical trial, participants perceived both QPS and GIS as equally helpful, but they had a more positive global view of and preferred the QPS. QPS facilitated generation of new questions without increasing patient anxiety nor prolonging the consultation. The findings provide support for increased adoption and integration of QPS into routine oncologic care. Trial RegistrationClinicalTrials.gov Identifier: NCT03287492

Few studies have examined the long-term impact of communication skills training for oncologists. We developed a year-long communication skills curriculum for medical oncology fellows with the primary goals of fostering life-long learning of patient-centered communication skills and internalization of associated attitudes and beliefs. We engaged learners through reflection, narrative methods, and action methods, thereby creating a non-threatening, team-based environment. The purpose of the current study was to determine whether learners perceived that they had acquired enduring skills, attitudes, and knowledge years after they participated. Former fellows completed an online cross-sectional survey from June to July 2019 that included demographic information, 21 items on a numerical scale, and 3 narrative prompts. Survey items pertained to 4 domains, including skills, attitudes, confidence with specific scenarios, and overall impressions. The numerical scale ranged from “strongly agree” = 1 to “strongly disagree” = 5. A total of 114 fellows, including 27 teaching assistants, participated in the communication skills training over 8 years. The average time between the end of the training program and completion of the survey was 5.2 years. The response rate was 68/114 (64

Context. Levorphanol is a potent opioid agonist and NMDA receptor blocker with minimal drug interactions, and there are few reports of its use in cancer patients.Objectives. We aimed to determine the frequency of successful opioid rotation (OR) to levorphanol and the median opioidMethods. This is a prospective, single-group, interventional study. Cancer outpatients requiring an OR and receiving a MEDD of 60-300 mg were rotated to levorphanol using a ratio of 10:1 and assessed daily for 10-day. Successful OR was defined as a 2-point improvement in the Edmonton Symptom Assessment System (ESAS) pain score on day 10 or achieving the personalized pain goal between days 3-10 in patients with uncontrolled pain or resolution of opioid side effects (OSE) in those undergoing OR for OSE alone. The ORR to levorphanol was calculated using net-MEDD (MEDD before OR minus the MEDD of the breakthrough opioid used along with levorphanol after OR). Results. Forty patients underwent OR to levorphanol, and uncontrolled pain 35/40 (87.5%) was the most common indication. The median net-MEDD and levorphanol doses were 95 and 10 mg, respectively, and 33/40 (82.5%) had a successful OR with a median (IQR) ORR of 8.56 (7.5-10). Successful OR was associated with significant improvement in ESAS and OSE scale scores. There was a strong association between MEDD and levorphanol dose.Conclusion. This study provided preliminary data that cancer patients could be successfully rotated to levorphanol using an ORR of 8.5. Levorphanol was associated with improved pain and symptom control and was well- tolerated. J Pain Symptom Manage 2023;65:e683-e690. (c) 2023 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

12006 Background: Terminal agitation commonly occurs in the last days of life and is highly distressing. The role of neuroleptics is controversial and few studies have examined agitation as a primary outcome. We assessed the effect of 3 neuroleptic strategies on refractory agitation in cancer patients with terminal delirium. Methods: In this single-center, double-blind, double-dummy parallel group randomized trial, patients admitted to a palliative and supportive care unit with refractory agitation despite low dose haloperidol were randomized in a 1:1:1 ratio to (1) haloperidol dose escalation, (2) neuroleptic rotation to chlorpromazine, or (3) combined haloperidol and chlorpromazine. Intravenous medications at equivalent doses were scheduled every 4 h and every 1 h as needed until discharge. The primary outcome was change in Richmond Agitation Sedation Scale (RASS) from time 0 to 24 hours. With 15 patients per group and 13 measurements over time, we had 90% power to detect an effect size of 0.2 with alpha=2.5%. One way ANOVA was used to examine within group differences. We also compared among groups with the Wilcoxon rank sum test. Results: 68 patients were enrolled and 45 received the blinded study interventions. The median survival was 73 h (95% CI 49, 106 h). RASS decreased significantly within 30 minutes and remained low at 24 hours in the dose escalation group (mean RASS change between 0 and 24 h [95% CI]: -3.6 [-5, -2.2]) v. rotation group (-3.3 [-4.4, -2.2]) v. combination group (-3 [-4.6, -1.4]), with no difference among groups (P=0.71). A majority of patients were perceived to be more comfortable after treatment by blinded caregivers (escalation v. rotation v. combination: 62% v. 71% v. 60%; P=0.83) and bedside nurses (64% v. 75% v. 64%; P=0.82); however, the rotation group had significantly fewer breakthrough restlessness (escalation v. rotation v. combination: 73% v. 19% v. 50%; P=0.009), required fewer upward dose titration (escalation v. rotation v. combination: 27% v. 6% v. 50%; P=0.03) and required less rescue neuroleptics in the first 24 hours (haloperidol equivalent: 4 mg vs. 2 mg vs. 6 mg, P=0.09, trend only). Hypotension was more frequently observed with chlorpromazine. Overall survival did not differ (>0.99). Conclusions: Preliminary data from this study supported that all 3 strategies of neuroleptics reduced agitation and improved comfort in patients with terminal delirium; however, neuroleptic rotation provided better agitation control and confirmatory studies are needed. Clinical trial information: NCT03021486 .

12021 Background: Despite compelling data supporting their use, patient reported outcomes (PROs) are not widely integrated into routine cancer care. In our Palliative Care (PC) practice, all patients complete the Edmonton Symptom Assessment Scale (ESAS), a simple, validated 10-item PRO tool which uses a 0 to 10 rating of 10 common symptoms (pain, fatigue, nausea, drowsiness, appetite, sleep, dyspnea, well-being, anxiety & depression). Our team has previously validated the Global Distress Score (GDS), a sum of 9 physical + psychosocial ESAS items. Here, we studied the implementation of the GDS as a streamlined way to capture the overall symptom burden while providing prognostic value. Methods: We queried a PC database for patients w metastatic cancer at time of 1st PC visit. GDS was calculated & grouped into 3 cohorts based on previous work & clinical experience: high (GDS of 35+), Moderate (16-34) or Low (0-15). Overall Survival was defined as time from 1st PC visit date to death. Regression analysis, ANOVA and t-tests were conducted. Results: 333 patients met the inclusion criteria: median age 62.4y (range 20.5-88.4y), 25 AYA (15-39y), 169 mid age (35-64y), 140 seniors (65y+); 190 female 143 male; median prior therapies 2 (range 0-11), 227 patients were in 2nd line + above therapy. Median ECOG PS 2; 124 patients w ECOG PS 3 & 33 w ECOG PS 4. 262 patients had died at time of analysis. Lower OS was associated w higher GDS (r 0.21, P < 0.001). OS in Low, Mod, High GDS cohorts was 13.1m, 7.9m, & 3.7m, respectively (p < 0.001). There were no sig OS difference between 3 age cohorts (AYA 5.2m, mid age 6m, seniors 5.4m, p0.56). Conclusions: Higher GDS score was associated with a clinically significant decrease in overall survival highlighting the potential of the ESAS as a PRO tool in prognostication and clinical decision making for patients with advanced cancers with a high symptom burden. In the realm of increasingly complex PRO instruments, the ESAS represents a simple, well-validated tool which, in our studies and 25 years of clinical experience, takes the patient less than a minute to complete, with subscores such as the GDS which carry a highly prognostic utility for patients with advanced cancers.

Palliative care is seeing cancer patients earlier in the disease trajectory with a multitude of chronic issues. Chronic non-malignant pain (CNMP) in cancer patients is under-studied. In this prospective study, we examined the prevalence and management of CNMP in cancer patients seen at our supportive care clinic for consultation. We systematically characterized each pain type with the Brief Pain Inventory (BPI) and documented current treatments. The attending physician made the pain diagnoses according to the International Association for the Study of Pain (IASP) task force classification. Among 200 patients (mean age 60 years, 69% metastatic disease, 1-year survival of 77%), the median number of pain diagnosis was 2 (IQR 1–2); 67 (34%, 95% CI 28–41%) had a diagnosis of CNMP; 133 (67%) had cancer-related pain; and 52 (26%) had treatment-related pain. In total, 12/31 (39%) patients with only CNMP and 21/36 (58%) patients with CNMP and other pain diagnoses were on opioids. There was a total of 94 CNMP diagnoses among 67 patients, including 37 (39%) osteoarthritis and 20 (21%) lower back pain; 30 (32%) were treated with opioids. In summary, CNMP was common in the timely palliative care setting and many patients were on opioids. Our findings highlight the need to develop clinical guidelines for CNMP in cancer patients to standardize its management.

Background The role of neuroleptics for terminal agitated delirium is controversial. We assessed the effect of three neuroleptic strategies on refractory agitation in patients with cancer with terminal delirium. Methods In this single-centre, double-blind, parallel-group, randomised trial, patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose haloperidol, were randomly assigned to receive intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1mg and chlorpromazine at 12.5 mg every 4 h, until death or discharge. Rescue doses identical to the scheduled doses were administered at inception, and then hourly as needed. Permuted block randomisation (block size six; 1:1:1) was done, stratified by baseline Richmond Agitation Sedation Scale (RASS) scores. Research staff, clinicians, patients, and caregivers were masked to group assignment. The primary outcome was change in RASS score from time 0 to 24 h. Comparisons among group were done by modified intention-to-treat analysis. This completed study is registered with ClinicalTrials.gov , NCT03021486. Findings Between July 5,2017, and July 1,2019,998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14). RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RAS S score change between 0 h and 24 h -3.6 [95% CI -5.0 to -2.2]), rotation group (n=11, -3.3 [-4.4 to -2.2]), and combination group (n=10, -3.0 [-4.6 to -1.4]), with no difference among groups (p=0.71). The most common serious toxicity was hypotension (escalation n=6 [40%], rotation n=5 [31%], combination n=3 [21%]); there were no treatment-related deaths. Interpretation Our data provide preliminary evidence that the three strategies of neuroleptics might reduce agitation in patients with terminal agitation. These findings are in the context of the single-centre design, small sample size, and lack of a placebo-only group. Copyright (C) 2020 Elsevier Ltd. All rights reserved.

The first time I met Donald S. Coffey was in late 1991 around midway through the first year of my medical oncology fellowship at Johns Hopkins. My classmates and I were attending a reception to meet prospective research mentors and to choose a lab for the ensuing 2 years, and Dr. Coffey was gracious enough to approach me to ask about my ideas and determine whether I may be a good fit to join his lab.

Oncology training focuses primarily on biomedical content rather than psychosocial content, which is not surprising in light of the enormous volume of technical information that oncology fellows assimilate in a short time. Nonetheless, the human connection, and specifically communication skills, remains as important as ever in caring for highly vulnerable patients with cancer. We previously described a year-long communication skills curriculum for oncology fellows that consisted of monthly 1-hour seminars with role play as the predominant teaching method (Epner and Baile, Acad Med. 89:578–84, 2014). Over several years, we adapted the curriculum based on learner feedback and reflection by faculty and teaching assistants and consolidated sessions into quarterly 3–4-hour workshops. We now describe integrating stories into the curriculum as a way of building empathy and warming fellows to the arduous task of dealing with highly emotional content, such as conversations with young patients about transitioning off disease-directed therapy. Learners read and discussed published, medically themed stories; discussed their own patient care stories; and completed brief writing reflections and discussions. They then worked in small groups facilitated by faculty and upper level fellows who functioned as teaching assistants to work on applying specific skills and strategies to scenarios that they chose. Fellows completed anonymous surveys on which they rated the curriculum highly for relevance, value, organization, content, and teaching methods, including storytelling aspects. We conclude that sharing stories can help highly technical learners build reflective ability, mindfulness, and empathy, which are all critical ingredients of the art of medicine.

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Palliative care specialists manage a variety of difficult medical and psychosocial situations across a wide spectrum of medical conditions. Patient–physician communication is a critical element for the provision of quality palliative care and improving patient satisfaction. It is essential for palliative care clinicians to be aware of the various challenging conversions they will encounter in their routine clinical care and to develop the necessary skill set to adequately address these. Several communication techniques, such as a sitting posture during a conversion, proper use of silence, listening, and recognizing emotional movements and responding to them, are important so as to improve clinical care for patients and their families.

IMPORTANCE The use of benzodiazepines to control agitation in delirium in the last days of life is controversial.OBJECTIVE To compare the effect of lorazepam vs placebo as an adjuvant to haloperidol for persistent agitation in patients with delirium in the setting of advanced cancer.DESIGN, SETTING, AND PARTICIPANTS Single-center, double-blind, parallel-group, randomized clinical trial conducted at an acute palliative care unit at MD Anderson Cancer Center, Texas, enrolling 93 patients with advanced cancer and agitated delirium despite scheduled haloperidol from February 11, 2014, to June 30, 2016, with data collection completed in October 2016.INTERVENTIONS Lorazepam (3 mg) intravenously (n = 47) or placebo (n = 43) in addition to haloperidol (2 mg) intravenously upon the onset of an agitation episode.MAIN OUTCOMES AND MEASURES The primary outcome was change in Richmond Agitation-Sedation Scale (RASS) score (range, -5 [unarousable] to 4 [very agitated or combative]) from baseline to 8 hours after treatment administration. Secondary end points were rescue neuroleptic use, delirium recall, comfort (perceived by caregivers and nurses), communication capacity, delirium severity, adverse effects, discharge outcomes, and overall survival.RESULTS Among 90 randomized patients (mean age, 62 years; women, 42 [47%]), 58 (64%) received the study medication and 52 (90%) completed the trial. Lorazepam + haloperidol resulted in a significantly greater reduction of RASS score at 8 hours (-4.1 points) than placebo + haloperidol (-2.3 points) (mean difference, -1.9 points [95% CI, -2.8 to -0.9]; P<.001). The lorazepam + haloperidol group required less median rescue neuroleptics (2.0 mg) than the placebo + haloperidol group (4.0 mg) (median difference, -1.0 mg [95% CI, -2.0 to 0]; P=.009) and was perceived to be more comfortable by both blinded caregivers and nurses (caregivers: 84% for the lorazepam + haloperidol group vs 37% for the placebo + haloperidol group; mean difference, 47%[95% CI, 14% to 73%], P=.007; nurses: 77% for the lorazepam + haloperidol group vs 30% for the placebo + haloperidol group; mean difference, 47%[95% CI, 17% to 71%], P=.005). No significant between-group differences were found in delirium-related distress and survival. The most common adverse effect was hypokinesia (3 patients in the lorazepam + haloperidol group [19%] and 4 patients in the placebo + haloperidol group [27%]).CONCLUSIONS AND RELEVANCE In this preliminary trial of hospitalized patients with agitated delirium in the setting of advanced cancer, the addition of lorazepam to haloperidol compared with haloperidol alone resulted in a significantly greater reduction in agitation at 8 hours. Further research is needed to assess generalizability and adverse effects.

10003 Background: Agitated delirium is a highly distressing neuropsychiatric syndrome common in the last days of life. The use of benzodiazepines for agitated delirium is highly controversial. We compared the effect of lorazepam versus placebo as an adjuvant to haloperidol for persistent agitated delirium. Methods: In this double-blind trial, we randomly assigned patients with advanced cancer admitted to an acute palliative care unit with agitated delirium despite scheduled haloperidol to either lorazepam 3 mg IV or placebo, in addition to haloperidol 2 mg IV upon the onset of agitation. The primary outcome was the Richmond Agitation Sedation Scale (RASS) over the first 8 hours, ranging from -5 (unarousable) to +4 (combative). Secondary endpoints were rescue neuroleptic use, perceived comfort, delirium-related distress, adverse effects and overall survival. 26 patients per arm provided 80% power to detect a between arm difference of 0.5 effect size in mean RASS with a=5%. We used the Wilcoxon Rank Sum test for primary comparison. Results: 52 of 58 (90%) patients who received the medications completed 8 h of observation. RASS decreased significantly within 30 min of treatment in both arms (Table). The lorazepam arm was associated with significantly greater reduction of RASS (Table), less rescue neuroleptics (mean haloperidol equivalent dose 1 mg v. 3 mg, P=0.02), and greater comfort as perceived by blinded caregivers (84% v. 37%, P=0.007) and nurses (77% v. 30%, P=0.005) compared to placebo. We found no significant between-group differences in delirium-related distress, adverse effects and overall survival (median 68 v. 73 h, P=0.56). Conclusions: The combination of lorazepam/haloperidol resulted in rapid and significant reduction of agitation compared to haloperidol alone. Our study supports the judicious use of single dose lorazepam/haloperidol for persistent agitated delirium. Clinical trial information: NCT01670097. [Table: see text]

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A patient-centered approach to medical decision making empowers patients but it also imposes new responsibilities upon them. Shared decision making neither relieves physicians of their obligation to guide patients when necessary nor obligates them to agree to patient requests that run counter to their deeply held moral convictions and professional integrity. The patient–physician relationship is now a reciprocal one, with rights and responsibilities on both sides. In this chapter, we will present clinical scenarios that illustrate ethical challenges that often arise during shared decision making, outline ethical principles that pertain to the scenarios, and describe key strategies and skills that physicians need to partner with the patient and family to develop the best plan of care.