Edmonton Symptom Assessment Scale Time Duration of Self-Completion Versus Assisted Completion in Patients with Advanced Cancer: A Randomized Comparison.

INTRODUCTION: To compare the time duration of self-completion (SC) of the Edmonton Symptom Assessment Scale (ESAS) by patients with advanced cancer (ACPs) versus assisted completion (AC) with a health care professional. MATERIALS AND METHODS: In this randomized comparison of ACPs seen in initial consultation at the outpatient Supportive Care Center at MD Anderson, ACPs who have never completed the ESAS at MD Anderson were allocated (1:1) to either SC of the ESAS form versus AC by a nurse. Time of completion was measured by the nurse using a stopwatch. Patients completed the Rapid Estimate of Adult Literacy in Medicine (REALM) test prior to administration of the ESAS. In the SC group, the nurse reviewed the responses to verify that the reported ESAS scores were correct. RESULTS: A total of 126 ACPs were enrolled (69 patients to AC and 57 to SC). Seventy-one patients were female, median age was 60 years, and median REALM score was 65. Median (interquartile range) time (in seconds) of SC was significantly less than AC (73 [42.9-89.1] vs. 109 [79.5-136.7], p < .0001). With nurse review time included, median time of SC increased to 117 seconds, which was not significantly different from AC (p = .28). Lower literacy (REALM) score and shortness of breath were significantly associated with increased completion time (p = .007). CONCLUSION: Regular use of ESAS will have minimal impact on clinical time, as it can be completed in about 1 minute and provides a concise yet comprehensive and multidimensional perspective of symptoms that affect quality of life of patients with cancer. IMPLICATIONS FOR PRACTICE: Because the Edmonton Symptom Assessment Scale can be completed in less than 2 minutes, hopefully the routine use of this simple yet comprehensive and multidimensional symptom assessment tool will be used at all medical visits in all patients with cancer so that the timely management of symptoms affecting patients' lives and treatment courses can occur, further enhancing personalized cancer care.

Response to Oral Immediate-Release Opioids for Breakthrough Pain in Patients with Advanced Cancer with Adequately Controlled Background Pain.

BACKGROUND: There is limited evidence about the response of breakthrough pain (BTP) to the most commonly used oral immediate-release (IR) opioids. Our aim was to determine response rate to oral IR opioids for BTP control in patients with advanced cancer. MATERIALS AND METHODS: In this prospective study, palliative care outpatients, with advanced cancer and adequately managed background pain, were asked to complete a self-administered survey. We assessed patients' baseline demographics, pain characteristics, alcoholism (CAGE questionnaire), tobacco and substance abuse, and Edmonton Symptom Assessment Scores (ESAS). We determined the effectiveness of oral IR BTP opioids by using a 7-point Likert scale ranging from "very ineffective" to "very effective." "Effective" and "very effective" were defined a priori as a good response to IR opioids for BTP. RESULTS: Of 592 evaluable patients, 192 (32%) had background pain of ≤3 (ESAS pain scale 0-10). Among these 192 patients, 152 (79%) reported BTP, 143/152 (94%) took oral IR opioids for BTP, and 127/143 (89%) responded to a median dose of 10% of the total morphine equivalent daily dose. In univariate logistic regression analysis, younger age (odds ratio [OR], 0.94 per year; p = .008), higher ESAS scores for pain (OR, 1.32; p = .012), anxiety (OR, 1.24; p = .017), and dyspnea (OR, 1.31; p = .007) had statistically significant association with poor response to IR opioids for BTP. In multicovariate logistic regression, adjusted for age, a higher ESAS dyspnea score was significantly associated with poor response to oral IR opioids (OR, 1.44; p = .002). CONCLUSION: The vast majority of patients with advanced cancer with adequately controlled background pain reported a good response to oral IR opioids for BTP, supporting their use in clinical practice. IMPLICATIONS FOR PRACTICE: Oral immediate-release opioids are standard treatment for cancer breakthrough pain. However, information regarding treatment response to these commonly used opioids is limited. This study provides information that the vast majority of patients with advanced cancer, with adequately controlled background pain, reported good response to oral immediate release opioids for managing their breakthrough pain episodes. Results of this study support the use of conventional oral immediate release opioids that are relatively inexpensive and readily available for management of breakthrough pain in patients with advanced cancer.

The Impact of an Educational Program on Patient Practices for Safe Use, Storage, and Disposal of Opioids at a Comprehensive Cancer Center.

BACKGROUND: Improper use, storage, and disposal of prescribed opioids can lead to diversion or accidental poisoning. Our previous study showed a large proportion of cancer patients have unsafe opioid practices. Our objective was to determine whether an improvement occurred in the patterns of use, storage, and disposal of opioids among cancer outpatients after the implementation of a patient educational program. PATIENTS AND METHODS: Our palliative care (PC) clinic provides every patient with educational material (EM) on safe opioid use, storage, and disposal every time they receive an opioid prescription. We prospectively assessed 300 adult cancer outpatients receiving opioids in our PC clinic, who had received the EM, and compared them with 300 patients who had not received the EM. The previously used surveys pertaining to opioid use, storage, and disposal were administered, and demographic information was collected. Sharing or losing their opioids was defined as unsafe use. RESULTS: Patients who received EM were more aware of the proper opioid disposal methods (76% vs. 28%; p ≤ .0001), less likely to share their opioids with someone else (3% vs. 8%; p = .0311), less likely to practice unsafe use of opioids (18% vs. 25%; p = .0344), and more likely to be aware the danger of their opioids when taken by others (p = .0099). Patients who received the EM were less likely to have unused medication at home (38% vs. 47%; p = .0497) and more likely to keep their medications in a safe place (hidden, 75% vs. 70%; locked, 14% vs. 10%; p = .0025). CONCLUSION: The use of EM on opioid safety for patients with advanced cancer was associated with improved patient-reported safe opioid use, storage, and disposal. The Oncologist 2017;22:115-121Implications for Practice: Prescription opioid abuse is a fast-growing epidemic that has become more prominent recently, even in the cancer pain population. A previous study reported that 26% of cancer outpatients seen in the supportive care center either lose their pain medications or share their pain medications with someone else. This study demonstrates that the implementation of an opioid educational program and distribution of educational material on opioid safety brings about an improvement in opioid storage, use, and disposal practices in patients being prescribed opioids for cancer-related pain. Our study highlights the importance of consistent and thorough opioid education at every instance in which opioids are prescribed.

A Double-Blind, Randomized, Placebo-Controlled Trial of Panax Ginseng for Cancer-Related Fatigue in Patients With Advanced Cancer.

Background: Despite the high frequency, severity, and effects of cancer-related fatigue (CRF) on the quality of life (QoL) of patients with cancer, limited treatment options are available. The primary objective of this study was to compare the effects of oral Panax ginseng extract (PG) and placebo on CRF. Secondary objectives were to determine the effects of PG on QoL, mood, and function. Methods: In this randomized, double-blind, placebo-controlled study, patients with CRF ≥4/10 on the Edmonton Symptom Assessment System (ESAS) were eligible. Based on a pilot study, we randomized patients to receive either 400 mg of standardized PG twice daily or a matching placebo for 28 days. The primary end point was change in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale from baseline to day 29. Results: Of 127 patients, 112 (88.2%) were evaluable. The mean (SD) FACIT-F subscale scores at baseline, day 15, and day 29 were 22.4 (10.1), 29.9 (10.6), and 30.1 (11.6) for PG (P<.001), and 24.0 (9.4), 30.0 (10.1), and 30.4 (11.5) for placebo (P<.001). Mean (SD) improvement in the FACIT-F subscale at day 29 was not significantly different in the PG than in the placebo group (7.5 [12.7] vs 6.5 [9.9]; P=.67). QoL, anxiety, depression, symptoms, and functional scores were not significantly different between the PG and placebo groups. Improvement in the FACIT-F subscale correlated with baseline scores (P=.0005), Hospital Anxiety and Depression Scale results (P=.032), and sex (P=.023). There were fewer any-grade toxicities in the PG versus placebo group (28/63 vs 33/64; P=.024). Conclusions: Both PG and placebo result in significant improvement in CRF. PG was not significantly superior to placebo after 4 weeks of treatment. There is no justification to recommend the use of PG for CRF. Further studies are needed. Trial Registration: ClinicalTrials.gov identifier: NCT01375114.

Effect of Lorazepam With Haloperidol vs Haloperidol Alone on Agitated Delirium in Patients With Advanced Cancer Receiving Palliative Care: A Randomized Clinical Trial.

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. Trial Registration: clinicaltrials.gov Identifier: NCT01949662.

Advanced cancer patients' reported wishes at the end of life: a randomized controlled trial.

CONTEXT: Conversations about end-of-life (EOL) wishes are challenging for many clinicians. The Go Wish card game (GWG) was developed to facilitate these conversations. Little is known about the type and consistency of EOL wishes using the GWG in advanced cancer patients. METHODS: We conducted a randomized controlled trial to assess the EOL wishes of 100 patients with advanced cancer treated at The University of Texas MD Anderson Cancer Center. The purpose of this study was to determine the EOL wishes of patients with advanced cancer and to compare patients' preference between the GWG and List of wishes/statements (LOS) containing the same number of items. Patients were randomized into four groups and completed either the GWG or a checklist of 35 LOS and one opened statement found on the GWG cards; patients were asked to categorize these wishes as very, somewhat, or not important. After 4-24 h, the patients were asked to complete the same or other test. Group A (n = 25) received LOS-LOS, group B (n = 25) received GWG-GWG, group C (n = 26) received GWG-LOS, and group D (n = 24) received LOS-GWG. All patients completed the State-Trait Anxiety Inventory (STAI) for adults before and after the first test. RESULTS: Median age (interquartile range = IQR): 56 (27-83) years. Age, sex, ethnicity, marital status, religion, education, and cancer diagnosis did not differ significantly among the four groups. All patients were able to complete the GWG and/or LOS. The ten most common wishes identified as very important by patients in the first and second test were to be at peace with God (74 vs. 71 %); to pray (62 vs. 61 %); and to have family present (57 vs. 61 %). to be free from pain (54 vs. 60 %); not being a burden to my family (48 vs. 49 %); to trust my doctor (44 vs. 45 %); to keep my sense of humor (41 vs. 45 %); to say goodbye to important people in my life (41 vs. 37 %); to have my family prepared for my death (40 vs. 49 %); and to be able to help others (36 vs. 31 %). There was significant association among the frequency of responses of the study groups. Of the 50 patients exposed to both tests, 43 (86 %) agreed that the GWG instructions were clear, 45 (90 %) agreed that the GWG was easy to understand, 31 (62 %) preferred the GWG, 39 (78 %) agreed that the GWG did not increase their anxiety and 31 (62 %) agreed that having conversations about EOL priorities was beneficial. The median STAI score after GWG was 48 (interquartile range, 39-59) vs. 47 (interquartile range, 27-63) after LOS (p = 0.2952). CONCLUSION: Patients with advanced cancer assigned high importance to spirituality and the presence/relationships of family, and these wishes were consistent over the two tests. The GWG did not worsen anxiety.

Characteristics and outcomes of patients with advanced cancer evaluated by a palliative care team at an emergency center. A retrospective study.

PURPOSE: Patients with advanced cancer may be referred for a palliative care consultation (PC) from a hospital emergency center (EC) or as inpatients. However, research about symptoms and outcomes in patients with advanced cancer who receive PC at the EC is limited. METHODS: We reviewed demographic variables, frequency and intensity of symptoms (using the Edmonton Symptom Assessment Scale (ESAS)), PC interventions, time from admission to PC consultation, hospitalization duration, and discharge destination of 200 advanced cancer patients referred to PC services from the EC ("EC patients") and 200 matched advanced cancer inpatients referred to PC services ("inpatients") from January 1, 2010, through December 31, 2011. RESULTS: The median age for all patients was 56 years (range, 48-64 years); 222 (56 %) patients were female, and 243 (61 %) were white. There were no significant demographic differences between the EC patients and inpatients. The median time from admission to PC was 12 h (range, 7-23 h) for the EC patients and 24 h (24-96 h) for the inpatients (p < 0.0001). For EC patients and inpatients, symptoms at presentation for PC consultation included uncontrolled pain (83 and 45 %, respectively; p < 0.0001), nausea/vomiting/constipation (41 and 19 %, respectively; p < 0.0001), and dyspnea (29 and 19 %, respectively; p = 0.02). The medians and interquartile ranges of baseline symptom intensities for EC patients and inpatients, respectively, were as follows: pain, 7 (5-9) and 5 (2-8) (p < 0.0001); fatigue, 7 (4-8) and 6 (4-8) (p = 0.0517); and sleep, 6 (0-8) and 4 (1-7) (p = 0.1064). At follow-up, improvement was observed in pain (125/238 [53 %]), sleep (59/131 [45 %]), well-being (32/82 [39 %]), fatigue (53/139 [38 %]), anxiety (51/132 [39 %]), appetite (46/132 [35 %]), dyspnea (49/160 [31 %]), nausea (52/170 [31 %]), depression (36/123 [29 %]), and drowsiness (37/126 [29 %]). After PC consultations, discharge/admission destinations for EC patients were as follows: home, 65 (33 %); home hospice, 13 (7 %); inpatient hospice, 8 (4 %); regular hospital floor, 65 (33 %); and PC unit, 46 (23 %). The median duration of hospitalization was 92 h (range, 69-114) for hospitalized EC patients and 125 h (range, 108-142) for inpatients (p < 0.0001). CONCLUSIONS: Referral to PC from the EC led to earlier delivery of PC with subsequent earlier control of symptoms. EC patients who received PC consultations and were hospitalized had shorter hospitalizations than PC referral in the inpatient area. More research is needed to describe the impact of PC services on symptom assessment and management and on goals and plan of care in patients with advanced illness admitted to the EC.

Frequency, intensity, and correlates of spiritual pain in advanced cancer patients assessed in a supportive/palliative care clinic.

OBJECTIVE: Regular assessments of spiritual distress/spiritual pain among patients in a supportive/palliative care clinic (SCPC) are limited or unavailable. We modified the Edmonton Symptom Assessment Scale (ESAS) by adding spiritual pain (SP) to the scale (0 = best, 10 = worst) to determine the frequency, intensity, and correlates of self-reported SP (≥1/10) (pain deep in your soul/being that is not physical) among these advanced cancer patients. METHOD: We reviewed 292 consecutive consults of advanced cancer patients (ACPs) who were evaluated at our SCPC between October of 2012 and January of 2013. Symptoms were assessed using the new instrument (termed the ESAS-FS). RESULTS: The median age of patients was 61 (range = 22-92). Some 53% were male; 189 (65%) were white, 45 (15%) African American, and 34 (12%) Hispanic. Some 123 of 282 (44%) of ACPs had SP (mean (95% CI) = 4(3.5-4.4). Advanced cancer patients with SP had worse pain [mean (95% CI) = 5.3(4.8, 5.8) vs. 4.5(4.0, 5.0)] (p = 0.02); depression [4.2(3.7, 4.7) vs. 2.1(1.7, 2.6), p < 0.0001]; anxiety [4.2(3.6, 4.7) vs. 2.5(2.0, 3.0), p < 0.0001]; drowsiness [4.2(3.7, 4.7) vs. 2.8(2.3, 3.2), p < 0.0001]; well-being [5.4(4.9, 5.8) vs. 4.5(4.1, 4.9), p = 0.0136]; and financial distress (FD) [4.4(3.9, 5.0) vs. 2.2(1.8, 2.7), p < 0.0001]. Spiritual pain correlated (Spearman) with depression (r = 0.45, p < 0.0001), anxiety (r = 0.34, p < 0.0001), drowsiness (r = 0.26, p < 0.0001), and FD (r = 0.44, p < 0.0001). Multivariate analysis showed an association with FD [OR (95% Wald CI) = 1.204(1.104-1.313), p < 0.0001] and depression [1.218(1.110-1.336), p < 0.0001]. The odds that patients who had SP at baseline would also have SP at follow-up were 182% higher (OR = 2.82) than for patients who were SP-negative at baseline (p = 0.0029). SP at follow-up correlated with depression (r = 0.35, p < 0.0001), anxiety (r = 0.25, p = 0.001), well-being (r = 0.27, p = 0.0006), nausea (r = 0.29, p = 0.0002), and financial distress (r = 0.42, p < 0.0001). SIGNIFICANCE OF RESULTS: Spiritual pain, which is correlated with physical and psychological distress, was reported in more than 40% of ACPs. Employment of the ESAS-FS allows ACPs with SP to be identified and evaluated in an SCPC. More research is needed.

Financial Distress and Its Associations With Physical and Emotional Symptoms and Quality of Life Among Advanced Cancer Patients.

OBJECTIVE: There are limited data on the effects of financial distress (FD) on overall suffering and quality of life (QOL) of patients with advanced cancer (AdCa). In this cross-sectional study, we examined the frequency of FD and its correlates in AdCa. PATIENTS AND METHODS: We interviewed 149 patients, 77 at a comprehensive cancer center (CCC) and 72 at a general public hospital (GPH). AdCa completed a self-rated FD (subjective experience of distress attributed to financial problems) numeric rating scale (0 = best, 10 = worst) and validated questionnaires assessing symptoms (Edmonton Symptom Assessment System [ESAS]), psychosocial distress (Hospital Anxiety and Depression Scale [HADS]), and QOL (Functional Assessment of Cancer Therapy-General [FACT-G]). RESULTS: The patients' median age was 60 years (95% confidence interval [CI]: 58.6-61.5 years); 74 (50%) were female; 48 of 77 at CCC (62%) versus 13 of 72 at GPH (18%) were white; 21 of 77 (27%) versus 32 of 72 (38%) at CCC and GPH, respectively, were black; and 7 of 77 (9%) versus 27 of 72 (38%) at CCC and GPH, respectively, were Hispanic (p < .0001). FD was present in 65 of 75 at CCC (86%; 95% CI: 76%-93%) versus 65 of 72 at GPH (90%; 95% CI: 81%-96%; p = .45). The median intensity of FD at CCC and GPH was 4 (interquartile range [IQR]: 1-7) versus 8 (IQR: 3-10), respectively (p = .0003). FD was reported as more severe than physical distress, distress about physical functioning, social/family distress, and emotional distress by 45 (30%), 46 (31%), 64 (43%), and 55 (37%) AdCa, respectively (all significantly worse for patients at GPH) (p < .05). AdCa reported that FD was affecting their general well-being (0 = not at all, 10 = very much) with a median score of 5 (IQR: 1-8). FD correlated (Spearman correlation) with FACT-G (r = -0.23, p = .0057); HADS-anxiety (r = .27, p = .0014), ESAS-anxiety (r = .2, p = .0151), and ESAS-depression (r = .18, p = .0336). CONCLUSION: FD was very frequent in both groups, but median intensity was double among GPH patients. More than 30% of AdCa rated FD to be more severe than physical, family, and emotional distress. More research is needed to better characterize FD and its correlates in AdCa and possible interventions. IMPLICATIONS FOR PRACTICE: Financial distress is an important and common factor contributing to the suffering of advanced cancer patients and their caregivers. It should be suspected in patients with persistent, refractory symptom expression. Early identification, measurement, and documentation will allow clinical teams to develop interventions to improve financial distress and its impact on quality of life of advanced cancer patients.

Cancer patients' perceptions regarding the value of the physical examination: a survey study.

BACKGROUND: Despite its clinical utility, progressive reliance on technology can lead to devaluing the physical examination in patients with advanced cancer. The primary objective of this study was to determine whether these patients have a positive or negative perception of the physical examination. A secondary objective was to determine whether these perceptions are related to interpersonal/relational values (symbolic) or diagnostic/objective values (pragmatic). METHODS: One hundred fifty patients with cancer who were receiving concurrent oncology and palliative care were administered a 26-item survey regarding their overall perception of the physical examination. The primary outcome-patient responses to "In the last 3 months, I believe my experience while being examined has been overall: very negative (a score of -5) to very positive (a score of +5),"-was analyzed using the Sign test. Other items were predefined as either symbolic or pragmatic statements, and patient responses from strongly disagree (a score of 1) to strongly agree (a score of 5) were further analyzed. Multivariable logistic regression was used to test for associations between baseline characteristics and the primary outcome. RESULTS: Most patients (83%) indicated that the overall experience of being examined was highly positive (median score, 4; interquartile range [IQR], 2-5; P ≤ .0001). Patients valued both the pragmatic aspects (median score, 5; IQR, 4-5) and symbolic aspects (median score, 4; IQR, 4-5) of the physical examination. Increasing age was independently associated with a more positive perception of the physical examination (odds ratio, 1.07 per year; 95% confidence interval, 1.02-1.12 per year; P = .01). CONCLUSIONS: Patients with advanced cancer indicate that the physical examination is a highly positive aspect of their care. These benefits are perceived as having both symbolic and pragmatic value. The physical examination should remain a cornerstone of clinical encounters.

Patterns of storage, use, and disposal of opioids among cancer outpatients.

PURPOSE: Improper storage, use, and disposal of prescribed opioids can lead to diversion or accidental poisoning. Our objective was to determine the patterns of storage, utilization, and disposal of opioids among cancer outpatients. PATIENTS AND METHODS: We surveyed 300 adult cancer outpatients receiving opioids in our supportive care center and collected information regarding opioid use, storage, and disposal, along with scores on the CAGE (cut down, annoyed, guilty, eye-opener) alcoholism screening questionnaire. Unsafe use was defined as sharing or losing opioids; unsafe storage was defined as storing opioids in plain sight. RESULTS: The median age was 57 years. CAGE was positive in 58 of 300 patients (19%), and 26 (9%) had a history of illicit drug use. Fifty-six (19%) stored opioids in plain sight, 208 (69%) kept opioids hidden but unlocked, and only 28 (9%) locked their opioids. CAGE-positive patients (p = .007) and those with a history of illicit drug use (p = .0002) or smoking (p = .03) were more likely to lock their opioids. Seventy-eight (26%) reported unsafe use by sharing (9%) or losing (17%) their opioids. Patients who were never married or single (odds ratio: 2.92; 95% confidence interval: 1.48-5.77; p = .006), were CAGE positive (40% vs. 21%; p = .003), or had a history of illicit drug use (42% vs. 23%; p = .031) were more likely to use opioids unsafely. Overall, 223 of 300 patients (74%) were unaware of proper opioid disposal methods, and 138 (46%) had unused opioids at home. CONCLUSION: A large proportion of cancer patients improperly and unsafely use, store, and dispose of opioids, highlighting the need for establishment of easily accessed patient education and drug take-back programs.

Frequency, outcome, and predictors of success within 6 weeks of an opioid rotation among outpatients with cancer receiving strong opioids.

BACKGROUND: Opioid rotation is used to treat uncontrolled pain and/or opioid-related adverse effects. Our aim was to determine the frequency, indications, outcomes, and predictors of successful opioid rotation in outpatients with cancer. METHODS: Medical records of consecutive outpatients with cancer who received strong opioids and returned for follow-up visit within ≤6 weeks to our supportive care center from January to December 2008 were reviewed. Data on patient characteristics, symptoms, opioid use, indications for opioid rotation, outcomes, and morphine equivalent daily dose were collected. Successful opioid rotation was defined as a two-point or 30% reduction in the symptom score or the resolution of opioid-induced neurotoxicity and continuation of the new opioid at follow-up. RESULTS: Opioid rotation was performed in 120 of 385 patients (31%). The median patient age was 55 years. There were 6/120 patients with missing data. Of the 114 evaluable patients, 68 (60%) were men, 81 (71%) were white, 27 (24%) had gastrointestinal cancer, and 90 (80%) had advanced-stage disease. The median Eastern Cooperative Oncology Group score was 1 (interquartile range: 1-2) and the median time between opioid rotation and follow-up was 14 days (interquartile range: 7-21 days). The most common indications for opioid rotation were uncontrolled pain (95/114; 83%) and opioid-induced neurotoxicity (13/114; 12%). A total of 35 patients (31%) had partial opioid rotation. The median improvements in pain and symptom distress score were -2 (interquartile range: -4 to 0; p < .001) and -5 (interquartile range: -14 to 7; p = .004), respectively. The morphine equivalent daily dose did not change significantly after opioid rotation (p = .156). A total of 65% of patients (74/114) had successful opioid rotation. There were no clinically significant independent predictors for successful opioid rotation. CONCLUSION: Opioid rotation was conducted in 31% of outpatients with cancer, with a 65% success rate. The most frequent reason for opioid rotation was uncontrolled pain. There were no independent predictors for successful opioid rotation.

Oral moxifloxacin for outpatient treatment of low-risk, febrile neutropenic patients.

OBJECTIVES: Low-risk febrile neutropenic patients can be treated without hospitalization with oral antibiotic regimens. Combination regimens are recommended. Our objective was to evaluate the feasibility of quinolone monotherapy (moxifloxacin) in this setting. METHODS: In this open-label pilot study, eligible low-risk febrile neutropenic patients identified using pre-defined criteria (MASCC Risk Index) received oral moxifloxacin (400 mg) in our emergency center and were discharged after a 4-8 h observation period to ensure clinical stability. They subsequently received moxifloxacin 400 mg daily as outpatients. Success of monotherapy, outpatient management, the development of adverse events, and major medical complications were recorded. RESULTS: The trial was closed without reaching the target sample size of 40 patients due to slow accrual. Twenty-one evaluable patients were enrolled, with sarcoma and breast cancer being the predominant underlying neoplasms. Most patients (76%) were severely neutropenic (

Effect of Prophylactic Fentanyl Buccal Tablet on Episodic Exertional Dyspnea: A Pilot Double-Blind Randomized Controlled Trial.

CONTEXT: Episodic dyspnea is one of the most common, debilitating, and difficult-to-treat symptoms. OBJECTIVE: We conducted a pilot study to examine the effect of prophylactic fentanyl buccal tablet (FBT) on exercise-induced dyspnea. METHODS: In this parallel, double-blind randomized placebo-controlled trial, opioid-tolerant patients were asked to complete a six-minute walk test (6MWT) at baseline and then a second 6MWT 30 minutes after a single dose of FBT (equivalent to 20-50% of their total opioid dose) or matching placebo. We compared dyspnea Numeric Rating Scale (NRS, 0-10, primary outcome), walk distance, vital signs, neurocognitive function, and adverse events between the two 6MWTs. RESULTS: Among 22 patients enrolled, 20 (91%) completed the study. FBT was associated with a significant within-arm reduction in dyspnea NRS between 0 and six minutes (mean change -2.4, 95% CI -3.5, -1.3) and respiratory rate (mean change -2.6, 95% CI -4.7, -0.4). Placebo was also associated with a nonstatistically significant decrease in dyspnea (mean change -1.1). Between-arm comparison of dyspnea scores in the second 6MWT favored FBT, albeit not statistically significant (estimate -0.25, P = 0.068). Global impression revealed more patients in the FBT group than placebo group reporting their dyspnea was at least "somewhat better" in the second 6MWT (4 of 9 vs. 0 of 11, P = 0.03). The other secondary outcomes did not differ significantly between arms. CONCLUSIONS: This study supports that prophylactic FBT was associated with a reduction of exertional dyspnea and was well tolerated. Our findings support the need for larger trials to confirm the therapeutic potential of rapid-onset opioids.

Association between Daytime Activity, Fatigue, Sleep, Anxiety, Depression, and Symptom Burden in Advanced Cancer Patients: A Preliminary Report.

BACKGROUND: There is limited research in advanced cancer patients (ACP) regarding association between objectively measured daytime activity and sleep (as measured by actigraphy), patient characteristics, and cancer symptoms (fatigue, sleep, anxiety, depression, cachexia, and symptom distress scores [SDSs]). OBJECTIVES: Our aim of the study was to determine the association between mean daytime activity (MDTA) and the following items: fatigue (FACIT-F), SDSs (Edmonton Symptom Assessment Scale [ESAS]), sleep quality (Pittsburg Sleep Quality Index [PSQI]), objective sleep variables (OSV) (sleep onset, sleep efficacy, wake after sleep onset, total sleep time), anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), body composition scores, and overall survival (OS). We also examined the association between sleep [PSQI and OSV scores] and FACIT-F, HADS, and ESAS. METHODS: Secondary analysis of a recent clinical trial of cancer-related fatigue in advanced cancer (NCT00424099). Association between MDTA and OSV (measured by actigraphy) during the first week of the study and patient characteristics, symptoms (FACIT-F, ESAS, HADS, and PSQI), and OS were analyzed. RESULTS: Seventy-nine eligible patients were evaluable. The median age was 57 years. Median MDTA was 248.43 counts/minute. Multivariate analysis shows that low MDTA was significantly associated with age, gender, Functional Assessment of Cancer Therapy (FACT)-Functional Well-Being (FWB), ESAS dyspnea, HADS-anxiety, and total sleep time. MDTA was not associated with FACIT-F (p = 0.997) and OS (p = 0.18). Sleep quality (PSQI) was significantly associated with FACIT-F, HADS, ESAS anxiety, and depression, but none of these variables was associated with OSV. CONCLUSION: In ACP, lower MDTA was significantly associated with age, gender, FACT-FWB, ESAS dyspnea, HADS-anxiety, and total sleep time. Both sleep quality and cancer-related fatigue scores were strongly associated with depression and anxiety. More research is needed.

Dexamethasone for Dyspnea in Cancer Patients: A Pilot Double-Blind, Randomized, Controlled Trial.

CONTEXT: Dexamethasone is often used to treat dyspnea in cancer patients, but evidence is lacking. OBJECTIVES: We determined the feasibility of conducting a randomized trial of dexamethasone in cancer patients and estimated the efficacy of dexamethasone in the treatment of dyspnea. METHODS: In this double-blind, randomized, controlled trial, patients with dyspnea ≥4 were randomized to receive either dexamethasone 8 mg twice daily × four days then 4 mg twice daily × three days or placebo for seven days, followed by an open-label phase for seven days. We documented the changes in dyspnea (0-10 numeric rating scale), spirometry measures, quality of life, and toxicities. RESULTS: A total of 41 patients were randomized and 35 (85%) completed the blinded phase. Dexamethasone was associated with a significant reduction in dyspnea numeric rating scale of -1.9 (95% CI -3.3 to -0.5, P = 0.01) by Day 4 and -1.8 (95% CI -3.2 to -0.3, P = 0.02) by Day 7. In contrast, placebo was associated with a reduction of -0.7 (95% CI -2.1 to 0.6, P = 0.38) by Day 4 and -1.3 (95% CI -2.4 to -0.2, P = 0.03) by Day 7. The between-arm difference was not statistically significant. Drowsiness improved with dexamethasone. Dexamethasone was well tolerated with no significant toxicities. CONCLUSION: A double-blind, randomized, controlled trial of dexamethasone was feasible with a low attrition rate. Our preliminary data suggest that dexamethasone may be associated with rapid improvement in dyspnea and was well tolerated. Further studies are needed to confirm our findings. TRIAL REGISTRATION: ClinicalTrials.govNCT01670097.

Patient Perception of Physician Compassion After a More Optimistic vs a Less Optimistic Message: A Randomized Clinical Trial.

IMPORTANCE: Information regarding treatment options and prognosis is essential for patient decision making. Patient perception of physicians as being less compassionate when they deliver bad news might be a contributor to physicians' reluctance in delivering these types of communication. OBJECTIVE: To compare patients' perception of physician compassion after watching video vignettes of 2 physicians conveying a more optimistic vs a less optimistic message, determine patients' physician preference after watching both videos, and establish demographic and clinical predictors of compassion. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial at an outpatient supportive care center in a cancer center in Houston, Texas, including English-speaking adult patients with advanced cancer who were able to understand the nature of the study and complete the consent process. Actors and patients were blinded to the purpose of the study. Investigators were blinded to the videos observed by the patient. INTERVENTION: One hundred patients were randomized to observe 2 standardized, roughly 4-minute videos depicting a physician discussing treatment information (more optimistic message vs less optimistic message) with a patient with advanced cancer. Both physicians made an identical number of empathetic statements (5) and displayed identical posture. After viewing each video, patients completed assessments including the Physician Compassion Questionnaire (0 = best, 50 = worst). MAIN OUTCOMES AND MEASURES: Patients' perception of physician compassion after being exposed to a more optimistic vs an equally empathetic but less optimistic message. RESULTS: Patients reported significantly better compassion scores after watching the more optimistic video as compared with the less optimistic video (median [interquartile range], 15 [5-23] vs 23 [10-31]; P < .001). There was a sequence effect favoring the second video on both compassion scores (P < .001) and physician preference (P < .001). Higher perception of compassion was found to be associated with greater trust in the medical profession independent of message type: 63 patients observing the more optimistic message ranked the physician as trustworthy vs 39 after the less optimistic message (P = .03). CONCLUSIONS AND RELEVANCE: Patients perceived a higher level of compassion and preferred physicians who provided a more optimistic message. More research is needed in structuring less optimistic message content to support health care professionals in delivering less optimistic news. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02357108.

High-Dose Asian Ginseng (Panax Ginseng) for Cancer-Related Fatigue: A Preliminary Report.

INTRODUCTION AND OBJECTIVE: Cancer-related fatigue (CRF) is the most common and severe symptom in patients with cancer. The number and efficacy of available treatments for CRF are limited. The objective of this preliminary study was to assess the safety of high-dose Panax ginseng (PG) for CRF. METHODS: In this prospective, open-label study, 30 patients with CRF (≥4/10) received high-dose PG at 800 mg orally daily for 29 days. Frequency and type of side effects were determined by the National Cancer Institute's Common Terminology Criteria for Adverse Events, version 4.0. Scores on the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale, Edmonton Symptom Assessment System (ESAS), and Hospital Anxiety and Depression Scale (HADS) were assessed at baseline, day 15, and day 29. Global Symptom Evaluation (GSE) was assessed at day 29. RESULTS: Of the 30 patients enrolled, 24 (80%) were evaluable. The median age was 58 years; 50% were females, and 84% were white. No severe (≥grade 3) adverse events related to the study drug were reported. Of the 24 evaluable patients, 21 (87%) had an improved (by ≥3 points) FACIT-F score by day 15. The mean ESAS score (standard deviation) for well-being improved from 4.67 (2.04) to 3.50 (2.34) (P = .01374), and mean score for appetite improved from 4.29 (2.79) to 2.96 (2.46) (P = .0097). GSE score of PG for fatigue was ≥3 in 15/24 patients (63%) with median improvement of 5. CONCLUSION: PG is safe and improves CRF fatigue as well as overall quality of life, appetite, and sleep at night. Randomized controlled trials of PG for CRF are justified.

In vitro antimicrobial activity of moxifloxacin compared to other quinolones against recent clinical bacterial isolates from hospitalized and community-based cancer patients.

The in vitro spectrum of moxifloxacin (a C-8-methoxyquinolone) was compared to that of ciprofloxacin and levofloxacin against 924 recent clinical isolates from cancer patients. Moxifloxacin was more active than the comparator agents against Gram-positive pathogens, with potent activity against Aerococcus spp., Listeria monocytogenes, Micrococcus spp., Rhodococcus equi, and Stomatococcus mucilaginous, methicillin-susceptible Staphylococcus spp., all beta hemolytic streptococci, viridans streptococci and Streptococcus pneumoniae. It also had good to moderate activity against Bacillus spp., Corynebacterium spp., Enterococcus faecalis, and methicillin-resistant staphylococci. Although ciprofloxacin was the most active agent tested against the Enterobacteriaceae, moxifloxacin inhibited the majority of these isolates at < or =2.0 microg/ml. Moxifloxacin was the least active of the three agents tested against Pseudomonas aeruginosa, but had significant activity against other non-fermentative Gram-negative bacilli including Acinetobacter spp., Flavobacterium spp., Pseudomonas spp. other than P. aeruginosa, and Stenotrophomonas maltophilia. The overall broad spectrum of moxifloxacin, and its availability for both oral and parenteral administration, warrants its evaluation for the prevention and treatment of infections in cancer patients.

Antimicrobial activity of a novel des-fluoro (6) quinolone, garenoxacin (BMS-284756), compared to other quinolones, against clinical isolates from cancer patients.

The in vitro spectrum of a novel des-fluoro (6) quinolone, garenoxacin (BMS-284756), was compared with that of ciprofloxacin, levofloxacin, and trovafloxacin against 736 clinical isolates from cancer patients. Garenoxacin was the most active agent overall against Gram-positive organisms, with potent activity against Aerococcus spp., Micrococcus spp., Rhodococcus equi, Stomatococcus mucilaginous, Bacillus spp., Enterococcus faecalis, Listeria monocytogenes, methicillin-susceptible Staphylococcus spp., and all beta-hemolytic and viridans streptococci. Although ciprofloxacin was the most active agent tested against the Enterobacteriaceae garenoxacin inhibited the majority of these isolates at