Cancer-related fatigue among patients with advanced cancer receiving immune-checkpoint inhibitors: a prospective study.

PURPOSE: The aim of this study was to determine the frequency and factors associated with severity of cancer related fatigue (CRF) as assessed by Functional Assessment of Cancer Illness Therapy-Fatigue (FACIT-F), prior to, and during 12 weeks of immune-checkpoint inhibitors (ICIs). We also explored the effects of ICIs on fatigue dimensions and interference with daily activities (Multidimensional Functional Symptom Inventory, MFSI-SF, Patient-Related Outcome Symptom Measurement Information System Short form Fatigue 7a, PROMIS F-SF), QOL (Functional Assessment of Cancer Therapy-General, FACT-G), and cancer symptoms (Edmonton Symptom Assessment Scale, ESAS). METHODS: In this prospective, longitudinal observational study, patients with a diagnosis of advanced cancer receiving ICIs were evaluated. Patient demographics, FACT-G, FACIT-F, MFSI-SF, PROMIS F-SF, and ESAS were collected prior to, and during 12 weeks of ICIs. RESULTS: A total of 160 of the 212 enrolled patients were analyzed. The median age was 61 years, 60% were female, most common cancer was melanoma (73%), and most common ICI was nivolumab 46%. The frequency of clinically significant fatigue (defined as ≤ 34/52 on FACIT-F score) was 25.6% at baseline, 25.7% at week 8, and 19.5% at week 12. There was significant improvement in FACIT-F (P = 0.016), FACT-G physical well-being (P = 0.041), FACT-G emotional well-being (P = 0.011), ESAS anxiety (P = 0.045), and ESAS psychological distress (P = 0.03) scores from baseline to week 12 of ICIs. Multivariate analysis found significant association between clinically significant CRF and PROMIS F-SF (P < 0.001) and MFSI-SF global scores (P < 0.001). CONCLUSIONS: CRF is frequent prior to the initiation of ICI treatment. Over 12 weeks of ICI treatment, CRF significantly improved. FACT-G physical well-being, FACT-G emotional well-being, ESAS anxiety, and ESAS psychological distress scores improved overtime. Further studies are needed to validate these findings.

Interdisciplinary intervention for the management of nonmedical opioid use among patients with cancer pain.

BACKGROUND: Few studies have assessed interventions aimed at managing nonmedical opioid use (NMOU) behavior among patients with cancer. The authors developed the Compassionate High-Alert Team (CHAT) intervention to manage patients receiving opioids for cancer pain who demonstrate NMOU behavior. The objective of this study was to determine the change in frequency of NMOU behaviors, pain intensity, and opioid requirements among those who received the intervention. METHODS: A total of 130 patients receiving opioids for cancer pain that had documented evidence of NMOU and received the CHAT intervention were reviewed. Demographic and clinical information such as NMOU behaviors, pain scores, and morphine equivalent daily dose at baseline, 3, and 6 months post-intervention was obtained. RESULTS: NMOU behaviors significantly decreased from a median (interquartile range) of 2 (1-3) at baseline to 0 (0-1) at both 3 and 6 months post-intervention (p < .001). A total of 45 of 75 (60%) and 31 of 50 (62%) of CHAT recipients achieved complete response to the intervention at 3 and 6 months, respectively. Higher baseline number of NMOU behaviors was independently associated with patient response to the intervention (odds ratio [OR], 1.97; 95% confidence interval [CI],1.09-4.28, p = .049 at 3 months; OR, 2.5; 95% CI, 1.20-6.47, p = .03 at 6 months). The median pain score decreased from 7 at baseline to 6 at both 3 and 6 months (p = .01). Morphine equivalent daily dose did not significantly change during that same period (143 mg/day vs. 139 mg/day, p = .13). CONCLUSIONS: Most patients who received the CHAT intervention improved in their NMOU behaviors and pain intensity scores 3 and 6 months post-intervention. These preliminary findings support the efficacy of CHAT in managing patients receiving opioids for cancer pain who demonstrate NMOU behavior.

Open-Label Placebo for the Treatment of Cancer-Related Fatigue in Patients with Advanced Cancer: A Randomized Controlled Trial.

BACKGROUND: The purpose of this study was to determine the effects of an open-labeled placebo (OLP) compared to a waitlist control (WL) in reducing cancer-related fatigue (CRF) in patients with advanced cancer using Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F). MATERIALS AND METHODS: In this randomized controlled trial, patients with fatigue ≥4/10 on Edmonton Symptom Assessment Scale (ESAS) were randomized to OLP one tablet twice a day or WL for 7 days. On day 8, patients of both arms received a placebo for 3 weeks. Changes in FACIT-F from baseline to day 8 (primary outcome) and at day 29, were assessed. Secondary outcomes included FACT-G, Multidimensional Fatigue Symptom Inventory-SF, Fatigue cluster (defined as a composite of ESAS fatigue, pain, and depression), Center for epidemiologic studies-depression, Godin leisure-time physical activity questionnaire, and global symptom evaluation. RESULTS: A total of 84/90 (93%) patients were evaluable. The mean (SD) FACIT-F change at day 8 was 6.6 (7.6) after OLP, vs. 2.1 (9.4) after WL (P = .016). On days 15 and 29, when all patients received OLP, there was a significant improvement in CRF and no difference between arms. There was also a significant improvement in ESAS fatigue, and fatigue cluster score in the OLP arm on day 8 of the study (0.029, and 0.044, respectively). There were no significant differences in other secondary outcomes and adverse events between groups. CONCLUSIONS: Open-labeled placebo was efficacious in reducing CRF and fatigue clusters in fatigued advanced cancer patients at the end of 1 week. The improvement in fatigue was maintained for 4 weeks. Further studies are needed.

Do Patients Benefit from a Trial of Corticosteroids at the End of Life?

OPINION STATEMENT: Patients with advanced cancer in the last 6 months of their lives have a higher frequency of distressing and debilitating physical and psychosocial symptoms such as cancer pain, cancer-related fatigue (CRF), anorexia, shortness of breath, poor sleep, anxiety, and depression. Often these symptoms significantly impact the patients' quality of life, and therefore require prompt assessment and effective treatment. There are specific treatments for certain distressing cancer-related symptoms (e.g., opioids for pain), but for the other symptoms such as CRF, anorexia-cachexia, and shortness of breath, there are limited or no evidence-based treatments. Also, in the management of cancer pain in this population, many patients are refractory to opioids. Hence, corticosteroids are one of the most common adjuvant medications prescribed for the management of this distressing symptom. However, there is limited evidence in regard to the effectiveness of corticosteroids in the improvement of the symptoms, side-effect profile, most optimal duration of use, dose, type of steroid, and most recently, the use with immunotherapy in advanced cancer patients at the end of life. These factors significantly limit the use of this important medication in terminally ill cancer patients. Further research is therefore critical to provide the optimal prescription of corticosteroids in this highly distressed population.

Frequency and characteristics of advanced cancer patients with COVID + ve status among inpatient supportive care consults during the pandemic: experience from a tertiary cancer center.

PURPOSE: There is limited literature available regards the frequency and characteristics of COVID-19 + ve status among advanced cancer patients referred to an inpatient supportive care consultation(PC) at a tertiary cancer center. Our study aimed to determine the frequency and characteristics of COVID-19 + ve cancer patients seen by PC. METHODS: Advanced cancer patients seen as a consult by PC between June 15 and September 25, 2020, at MD Anderson Cancer Center were eligible for the study. We evaluated the patient demographics, clinical characteristics including symptoms(ESAS), delirium(MDAS), COVID + status prior to, and after PC referral(converters), and type of PC delivery(in person or virtual care). RESULTS: Sixty-six out of 1380 (4.8%) PC consults were COVID-19 + ve: 42 prior to PC (79%), and 14 (21%) were COVID-19 + ve after the PC (converters). COVID-19 + PC patients had lower depression (P = .035), spiritual distress (P = .003), and were more seen frequently virtually (P < 0.001). There was no significant difference between COVID-19-ve patients and converters. Converters had higher symptom distress (P = 0.007), lower delirium (P = 0.014), and were referred earlier (P = .011) compared to COVID + PC patients diagnosed prior to PC consult. Overall, patients seen virtually compared in-person by PC were younger (P = 0.02) and had lower delirium (P = 0.007). CONCLUSION: The burden of COVID-19 + status among patients referred to PC was low. COVID-19 + ve patients had more frequent virtual visits, lower depression, and spiritual distress scores. Patient seen virtually were significantly younger and had lower delirium. During a new pandemic, universal virtual care might be emphasized especially at initial encounters after admission and further research is needed on the potential efficacy of this intervention.

Sleep disturbance in cancer patients referred to an ambulatory integrative oncology consultation.

BACKGROUND: Sleep disturbance (SD) is highly prevalent in oncology and negatively affects quality of life and mortality. Evidence supports the use of integrative oncology (IO) practices to treat SD, but there is limited published data on the characteristics of SD and factors associated with SD in IO. We determined the prevalence, severity, and factors associated with SD among cancer patients seen in an ambulatory IO consultation. METHODS: Patients with cancer referred for initial outpatient IO consultation in 2017 were eligible. Patient demographics, clinical characteristics, and patient-reported outcomes (Edmonton Symptom Assessment Scale (ESAS), Measure Yourself Concerns and Wellbeing (MYCaW), PROMIS-10) were retrospectively reviewed. RESULTS: One thousand five hundred twenty patients were included in the analysis. The majority (70%) were women with breast cancer (42%). Nine hundred seventy-one (64%) patients reported significant SD with ESAS Sleep ≥ 4, yet only 11% expressed poor sleep as their primary or secondary concern for the IO consultation. The median SD (IQR) was 5 (3,7). ESAS scores for fatigue (adjusted OR 1.16; CI 1.07-1.26, p < 0.001), pain (adjusted OR 1.07; CI 1.00-1.15, p < 0.05), hot flashes (adjusted OR 1.14; CI 1.07-1.22, p < 0.001), well-being (adjusted OR 1.33; CI 1.22-1.46, p < 0.001), and psychological distress score (anxiety and depression) (adjusted OR 1.16; CI 1.01-1.11, p < 0.01) were independently associated with SD in multivariate analysis. Acupuncture was the most frequent intervention prescribed, 175 (35%). Other modalities included oncology massage (15%), health psychology (5%), and meditation (1%). CONCLUSIONS: Although 64% of patients seeking IO consultation reported clinically significant SD, only 11% were seeking integrative approaches for managing SD. ESAS fatigue, hot flashes, well-being, and psychological symptoms were significantly associated with SD.

Anamorelin combined with physical activity, and nutritional counseling for cancer-related fatigue: a preliminary study.

PURPOSE: Cancer-related fatigue (CRF) is the most frequent and debilitating symptom in patients with advanced cancer. There are limited effective treatments for CRF. The objective of this prospective longitudinal study was to evaluate the change in CRF at Day 43 after treatment with combination therapy of oral Anamorelin 100 mg daily with physical activity and nutrition counseling. METHODS: In this study, patients with CRF [≤ 34 Functional Assessment of Chronic Illness Therapy-Fatigue subscales(FACIT-F)] received Anamorelin 100 mg orally daily with standardized physical activity and nutrition counseling for 43 days. Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Anorexia Cachexia(FAACT-ACS), Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF), Patient-Reported Outcomes Measurement Information System(PROMIS-Fatigue), body composition, and physical performance tests were assessed at baseline, Day 15, 29, and 43. Frequency and type of side effects were determined by NCI CTAE 4.0.(NCT03035409). RESULTS: 28/45 (62%) of patients dosed were evaluable at Day 43. The mean, SD for FACIT-F subscale improvement from baseline was 4.89 (± 13.07), P = .058, MFSI-SF (G) - 3.46 (± 6.86), P = 0.013, PROMIS-fatigue - 4.14 (± 7.88), P = 0.010, FAACT ACS 3.48 (± 8.13), P = 0.035. Godin Liesure-Time physical activity questionnaire 7.41 (± 16.50), P = 0.038. Weight (kg) 1.81 (± 2.63), P = 0.005, and Lean Body Mass 1.54 (± 1.85), P = 0.001, IGF-1 36.50 (± 48.76), P = 0.015. There was no significant improvement in physical performance outcomes. No adverse events > grade 3 related to the study drug were reported. CONCLUSION: The use of the combination therapy was associated with improvement of CRF (FACIT-F fatigue, PROMIS-fatigue, MFSI-SF-general), activity (Godin-leisure time), anorexia (FAACT), body composition, and IGF-1 levels. Further studies using combination therapy for CRF are justified.

Random urine drug testing among patients receiving opioid therapy for cancer pain.

BACKGROUND: There is limited information regarding the true frequency of nonmedical opioid use (NMOU) among patients receiving opioid therapy for cancer pain. Data to guide patient selection for urine drug testing (UDT) as well as the timing and frequency of ordering UDT are insufficient. This study examined the frequency of abnormal UDT among patients with cancer who underwent random UDT and their characteristics. METHODS: Demographic and clinical information for patients with cancer who underwent random UDT were retrospectively reviewed and compared with a historical cohort that underwent targeted UDT. Random UDT was ordered regardless of a patient's risk potential for NMOU. Targeted UDT was ordered on the basis of a physician's estimation of a patient's risk for NMOU. RESULTS: In all, 552 of 573 eligible patients (96%) underwent random UDT. Among these patients, 130 (24%) had 1 or more abnormal results; 38 of the 88 patients (43%) who underwent targeted UDT had 1 or more abnormal results. When marijuana was excluded, 15% of the random group and 37% of the targeted group had abnormal UDT findings (P < .001). It took a shorter time from the initial consultation to detect 1 or more abnormalities with the random test than the targeted test (median, 130 vs 274 days; P = .02). Abnormal random UDT was independently associated with younger age (P < .0001), male sex (P = .03), Cut Down, Annoyed, Guilty, and Eye Opener-Adapted to Include Drugs positivity (P = .001), and higher Edmonton Symptom Assessment System anxiety (P = .01). CONCLUSIONS: Approximately 1 in 4 patients receiving opioids for cancer pain at a supportive care clinic who underwent random UDT had 1 or more abnormalities. Random UDT detected abnormalities earlier than the targeted test. These findings suggest that random UDT is justified among patients with cancer pain.

Combination Therapy of Physical Activity and Dexamethasone for Cancer-Related Fatigue: A Phase II Randomized Double-Blind Controlled Trial.

BACKGROUND: Despite the high frequency of cancer-related fatigue (CRF) and its debilitating effects on the quality of life of patients with advanced cancer, there are limited treatment options available. Treatments including physical activity (PA) or dexamethasone (Dex) improve CRF; however, they have lower adherence rates (PA) or long-term adverse effects (Dex). The aim of this study was to determine the feasibility of and preliminary results for the combination of PA and Dex in improving CRF. METHODS: In this phase II randomized controlled trial, patients with advanced cancer and CRF scores of ≥4/10 on the Edmonton Symptom Assessment Scale were eligible. Patients were randomized to standardized PA for 4 weeks with either 4 mg of Dex (LoDex arm) or 8 mg of Dex (HiDex arm) twice a day for 7 days. Feasibility and change in the Functional Assessment of Cancer Illness Therapy-Fatigue subscale (FACIT-F) from baseline to day 8 and day 29 (primary outcome) were assessed. Secondary outcomes included changes in fatigue dimensions (FACIT-General, Patient-Reported Outcomes Measurement Information System [PROMIS]-Fatigue). RESULTS: A total of 60 of 67 (90%) patients were evaluable. All patients were adherent to study medication. We found that 84% and 65% of patients in the LoDex arm and 96% and 68% of patients in the HiDex arm were adherent to aerobic and resistance exercise, respectively. The FACIT-F effect size in the LoDex arm was 0.90 (P<.001) and 0.92 (P<.001) and the effect size in the HiDex arm was 0.86 and 1.03 (P<.001 for both) at days 8 and 29, respectively. We found significant improvements in the Functional Assessment of Cancer Therapy-Physical (P≤.013) and the PROMIS-Fatigue (P≤.003) at days 8 and 29 in both arms. Mixed-model analysis showed a significant improvement in the FACIT-F scores at day 8 (P<.001), day 15 (P<.001), and day 29 (P=.002). Changes in the FACIT-F scores were not significantly different between patients in the 2 arms (P=.86). CONCLUSIONS: Our study found that the combination therapy of PA with Dex was feasible and resulted in the improvement of CRF. The improvement was seen for up to 3 weeks after the discontinuation of Dex. Further larger studies are justified. CLINICALTRIALS: gov identifier: NCT02491632.

Evaluation and Management of Sleep and Circadian Rhythm Disturbance in Cancer.

OPINION STATEMENT: Sleep and circadian rhythm disturbance are among the most commonly experienced symptoms in patients with cancer. These disturbances occur throughout the spectrum of cancer care from diagnosis, treatment, and long into survivorship. The pathogenesis of these symptoms and disturbances is based on common inflammatory pathways related to cancer and its' treatments. The evaluation of sleep and circadian disorders requires an understanding of how these symptoms cluster with other cancer-related symptoms and potentiate each other. A thorough evaluation of these symptoms and disorders utilizing validated diagnostic tools, directed review of clinical information, and diagnostic testing is recommended. Treatment of sleep and circadian disturbance in cancer patients should be based on the findings of a detailed evaluation, including specific treatment of primary sleep and circadian disorders, and utilize integrative and personalised management of cancer-related symptoms through multiple pharmacologic and non-pharmacologic modalities. Recognition, evaluation, and treatment of sleep and circadian rhythm disturbance in cancer may lead to improved symptom management, quality of life, and outcomes.

The development of a nomogram to determine the frequency of elevated risk for non-medical opioid use in cancer patients.

OBJECTIVE: Non-medical opioid use (NMOU) is a growing crisis. Cancer patients at elevated risk of NMOU (+risk) are frequently underdiagnosed. The aim of this paper was to develop a nomogram to predict the probability of +risk among cancer patients receiving outpatient supportive care consultation at a comprehensive cancer center. METHOD: 3,588 consecutive patients referred to a supportive care clinic were reviewed. All patients had a diagnosis of cancer and were on opioids for pain. All patients were assessed using the Edmonton Symptom Assessment Scale (ESAS), Screener and Opioid Assessment for Patients with Pain (SOAPP-14), and CAGE-AID (Cut Down-Annoyed-Guilty-Eye Opener) questionnaires. "+risk" was defined as an SOAPP-14 score of ≥7. A nomogram was devised based on the risk factors determined by the multivariate logistic regression model to estimate the probability of +risk. RESULTS: 731/3,588 consults were +risk. +risk was significantly associated with gender, race, marital status, smoking status, depression, anxiety, financial distress, MEDD (morphine equivalent daily dose), and CAGE-AID score. The C-index was 0.8. A nomogram was developed and can be accessed at https://is.gd/soappnomogram. For example, for a male Hispanic patient, married, never smoked, with ESAS scores for depression = 3, anxiety = 3, financial distress = 7, a CAGE score of 0, and an MEDD score of 20, the total score is 9 + 9+0 + 0+6 + 10 + 23 + 0+1 = 58. A nomogram score of 58 indicates the probability of +risk of 0.1. SIGNIFICANCE OF RESULTS: We established a practical nomogram to assess the +risk. The application of a nomogram based on routinely collected clinical data can help clinicians establish patients with +risk and positively impact care planning.

Frequency and characteristics of drowsiness, somnolence, or daytime sleepiness in patients with advanced cancer.

INTRODUCTION: Cancer-related drowsiness (CRD) is a distressing symptom in advanced cancer patients (ACP). The aim of this study was to determine the frequency and factors associated with severity of CRD. We also evaluated the screening performance of Edmonton Symptom Assessment Scale-drowsiness (ESAS-D) item against the Epworth Sedation Scale (ESS). METHOD: We prospectively assessed 180 consecutive ACP at a tertiary cancer hospital. Patients were surveyed using ESAS, ESS, Pittsburgh Sleep Quality Index, Insomnia Severity Index, and Hospital Anxiety Depression Scale. RESULT: Ninety of 150 evaluable patients had clinically significant CRD (ESS); median (interquartile ratio): ESS. 11 (7-14); ESAS-D. 5 (2-6); Pittsburgh Sleep Quality Index. 8 (5-11); Insomnia Severity Index. 13 (5-19); Stop Bang Scoring 3 (2-4), and Hospital Anxiety Depression Scale-D 6 (3-10). ESAS-D was associated with ESAS (r, p) sleep (0.38, <0.0001); pain (0.3, <0.0001); fatigue (0.51, <0.0001); depression (0.39, <0.0001); anxiety (0.44, <0.0001); shortness of breath (0.32, <0.0001); anorexia (0.36, <0.0001), feeling of well-being [(0.41, <0.0001), ESS (0.24, 0.001), and opioid daily dose (0.19, 0.01). Multivariate-analysis showed ESAS-D was associated with fatigue (odds ratio [OR] = 9.08, p < 0.0001), anxiety (3.0, p = 0.009); feeling of well-being (OR = 2.27, p = 0.04), and insomnia (OR = 2.35; p = 0.036). Insomnia (OR = 2.35; p = 0.036) cutoff score ≥3 (of 10) resulted in a sensitivity of 81% and 32% and specificity of 70% and 44% in the training and validation samples, respectively. SIGNIFICANCE OF RESULTS: Clinically significant CRD is frequent and seen in 50% of ACP. CRD was associated with severity of insomnia, fatigue, anxiety, and worse feeling of well-being. An ESAS-D score of ≥3 is likely to identify most of the ACP with significant CRD.

Predicting the risk for aberrant opioid use behavior in patients receiving outpatient supportive care consultation at a comprehensive cancer center.

BACKGROUND: Opioid misuse is a growing crisis. Patients with cancer who are at risk of aberrant drug behaviors are frequently underdiagnosed. The primary objective of this study was to determine the frequency and factors predicting a risk for aberrant opioid and drug use behaviors (ADB) among patients who received an outpatient supportive care consultation at a comprehensive cancer center. In addition, the screening performance of the Cut Down-Annoyed-Guilty-Eye Opener (CAGE) questionnaire adapted to include drug use (CAGE-AID) was compared with that of the 14-item Screener and Opioid Assessment for Patients With Pain (SOAPP-14) tool as instruments for identifying patients at risk for ADB. METHODS: In total, 751 consecutive patients with cancer who were referred to a supportive care clinic were reviewed. Patients were eligible if they had diagnosis of cancer and had received opioids for pain for at least 1 week. All patients were assessed using the Edmonton Symptom Assessment Scale (ESAS), the SOAPP-14, and the CAGE-AID. SOAPP scores ≥7 (SOAPP-positive) were used to identify patients who were at risk of ADB. RESULTS: Among the 729 of 751 (97%) evaluable consults, 143 (19.6%) were SOAPP-positive, and 73 (10.5%) were CAGE-AID-positive. Multivariate analysis revealed that the odds ratio of a positive SOAPP score was 2.3 for patients who had positive CAGE-AID scores (P < .0001), 2.08 for men (P = .0013), 1.10 per point for ESAS pain (P = .014), 1.13 per point for ESAS anxiety (P = .0015), and 1.09 per point for ESAS financial distress (P = .012). A CAGE-AID cutoff score of 1 in 4 had 43.3% sensitivity and 90.93% specificity for screening patients with a high risk of ADB. CONCLUSIONS: The current results indicate a high frequency of an elevated risk of ADB among patients with cancer. Men and patients who have anxiety, financial distress, and a prior history of alcoholism/illicit drug use are at increased risk of ADB.

Perception of Curability Among Advanced Cancer Patients: An International Collaborative Study.

BACKGROUND: There are limited data on illness understanding and perception of cure among advanced cancer patients around the world. The aim of the study was to determine the frequency and factors associated with inaccurate perception of curability among advanced cancer patients receiving palliative care across the globe. MATERIALS AND METHODS: Secondary analysis of a study to understand the core concepts in end-of-life care among advanced cancer patients receiving palliative care from 11 countries across the world. Advanced cancer patients were surveyed using a Patient Illness Understanding survey and Control Preference Scale. Descriptive statistics and multicovariate logistic regression analysis were performed. RESULTS: Fifty-five percent (763/1,390) of patients receiving palliative care inaccurately reported that their cancer is curable. The median age was 58, 55% were female, 59% were married or had a partner, 48% were Catholic, and 35% were college educated. Sixty-eight percent perceived that the goal of therapy was "to get rid of their cancer," and 47% perceived themselves as "seriously ill." Multicovariate logistic regression analysis shows that accurate perception of curability was associated with female gender (odds ratio [OR] 0.73, p = .027), higher education (OR 0.37, p < .0001), unemployment status (OR 0.69, p = .02), and being from France (OR 0.26, p < .0001) and South Africa (OR 0.52, p = .034); inaccurate perception of curability was associated with better Karnofsky performance status (OR 1.02 per point, p = .0005), and being from Philippines (OR 15.49, p < .0001), Jordan (OR 8.43, p < .0001), Brazil (OR 2.17, p = .0037), and India (OR 2.47, p = .039). CONCLUSION: Inaccurate perception of curability in advanced cancer patients is 55% and significantly differs by gender, education, performance status, employment status, and country of origin. Further studies are needed to develop strategies to reduce this misperception of curability in advanced cancer patients. IMPLICATIONS FOR PRACTICE: The findings of this study indicate that inaccurate perception of curability among advanced cancer patients is 55%. Inaccurate perception of curability significantly differs by gender, education, performance status, employment status, and country of origin. There is great need to facilitate improved patient-physician communication so as to improve health care outcomes and patient satisfaction.

Decisional control preferences among patients with advanced cancer: An international multicenter cross-sectional survey.

BACKGROUND: Understanding patients' decision control preferences is important in providing quality cancer care. Patients' decisional control preference can be either active (patients prefer to make decisions themselves), shared (collaborative between patient, their physician, and/or family), or passive (patients prefer that the decisions are made by either the physician and/or their family). AIM: To determine the frequency and predictors of passive decision control preferences among advanced cancer patients. We also determined the concordance between actual decision-making and decision control preferences and its association with patient satisfaction. DESIGN: In this cross-sectional survey of advanced cancer patients referred to palliative care across 11 countries, we evaluated sociodemographic variables, Control Preference Scale, and satisfaction with the decisions and care. RESULTS: A total of 1490 participants were evaluable. Shared, active, and passive decision control preferences were 33%, 44%, and 23%, respectively. Passive decision control preferences (odds ratio, p value) was more frequent in India (4.34, <0.001), Jordan (3.41, <0.001), and France (3.27, <0.001). Concordance between the actual decision-making and decision control preferences was highest in the United States ( k = 0.74) and lowest in Brazil (0.34). Passive decision control preference was significantly associated with (odds ratio per point, p value) better performance status (0.99/point, 0.017), higher education (0.64, 0.001), and country of origin (Brazil (0.26, <0.0001), Singapore (0.25, 0.0003), South Africa (0.32, 0.0002), and Jordan (2.33, 0.0037)). CONCLUSION: Passive decision control preferences were less common (23%) than shared and active decision control preference even among developing countries. Significant predictors of passive decision control preferences were performance status, education, and country of origin.

Factors associated with patient-reported subjective well-being among advanced lung or non-colonic gastrointestinal cancer patients.

OBJECTIVE: The aim of this study was to determine the factors associated with a feeling of well-being using the Edmonton Symptom Assessment Scale (ESAS)-Feeling of Well-Being item (ESAS-FWB; where 0 = best and 10 = worst) among advanced lung or non-colonic gastrointestinal cancer patients who were referred to an outpatient palliative care clinic (OPCC). We also examined the association of performance on the ESAS-FWB with overall survival (OS). METHOD: We reviewed the records of consecutive patients with incurable advanced lung cancer and non-colonic gastrointestinal cancer presenting to an OPCC from 1 January 2008 through to 31 December 2013. Descriptive statistics were employed to summarize patient characteristics. Multivariate regression analysis was used to determine the factors associated with ESAS-FWB severity. We also examined the association of ESAS-FWB scores and survival using Kaplan-Meier survival analysis. RESULTS: A total of 826 evaluable patients were analyzed (median age = 62 years, 57% male). Median ESAS-FWB scores were five times the interquartile range (5 × IQR; 3-7). ESAS-FWB score was found to be significantly associated with ESAS fatigue (OR = 2.31, p < 0.001); anxiety (OR = 1.98, p < 0.001); anorexia (OR = 2.31, p < 0.001); cut down, annoyed, guilty, eye opener (CAGE) score (hazard ratio [HR] = 1.80, p = 0.008); and family caregiver distress (HR = 1.93, p = 0.002). A worse ESAS-FWB score was significantly associated with decreased OS (r = -0.18, p < 0.001). However, ESAS-FWB score was not independently associated with OS in the final multivariate model (p = 0.35), which included known major clinical prognostic factors. CONCLUSIONS: Worse ESAS-FWB scores were significantly associated with high scores on ESAS fatigue, anorexia, anxiety, CAGE, and family caregiver distress. More research is necessary to understand how palliative care interventions are capable of improving the contributory factors related to ESAS-FWB score.

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.

Characteristics of patients with advanced lung cancer referred to a rapid-access supportive care clinic.

OBJECTIVE: There is a limited number of pragmatic studies to evaluate the criteria for referral to outpatient palliative care. The aim of our study was to compare the characteristics, symptoms, and survival of patients with advanced non-small-cell lung cancer (NSCLC) referred (RF) versus not referred (NRF) to a novel embedded same-day rapid-access supportive care clinic (RASCC) and to compare the subgroups among referred patients. METHOD: We reviewed the medical records of all patients who received treatment at the thoracic oncology clinic for advanced non-small-cell lung cancer between August 1, 2012, and June 30, 2013, who were referred to the RASCC and those who were not referred. An oncology-estimated prognosis of ≤6 months and/or severe symptom distress was employed as criteria for referral to the RASCC. RESULTS: Of 410 eligible patients, 155 (37.8%) were referred to the RASCC. RF patients had significantly higher patient-reported scores for pain, fatigue, lack of appetite, and symptom distress, as well as worse performance status and shorter survival than NRF patients. Among the RF patients, those who were referred early (≤3 months) had significantly worse symptom distress and shorter overall survival than patients who were referred later on. The patients treated by thoracic oncologists who referred a smaller proportion of their patients to the RASCC had significantly worse anxiety, well-being, spiritual pain, and symptom distress than patients treated by those who referred a larger proportion of their patients to the RASCC. SIGNIFICANCE OF RESULTS: We found that patients who were referred to the RASCC had higher reported symptom distress and worse survival ratings. Further studies are needed to evaluate the optimal criteria for timely integration of palliative care and oncology care.

The opioid rotation ratio of strong opioids to transdermal fentanyl in cancer patients.

BACKGROUND: Transdermal fentanyl (TDF) is 1 of the most common opioids prescribed to patients with cancer. However, the accurate opioid rotation ratio (ORR) from other opioids to TDF is unknown, and various currently used methods result in wide variation of the ORR. The objective of this study was to determine the ORR of the oral morphine equivalent daily dose (MEDD) to the TDF dose when correcting for the MEDD of breakthrough opioids (the net MEDD) in cancer outpatients. METHODS: The records of 6790 consecutive patients were reviewed at the authors' supportive care center from 2010 to 2013 to identify those who underwent rotation from other opioids to TDF. Data regarding Edmonton Symptom Assessment Scale scores and MEDDs were collected for patients who returned for a follow-up visit within 5 weeks. Linear regression analysis was used to estimate the ORR between the TDF dose and the net MEDD (the MEDD before opioid rotation [OR] minus the MEDD of the breakthrough opioid used along with TDF after OR). RESULTS: In total, 129 patients underwent OR from other opioids to TDF. The mean patient age was 56 years, 59% were men, and 88% had advanced cancer. Uncontrolled pain (80%) was the most frequent reason for OR. In 101 patients who underwent OR and had no worsening of pain at follow-up, the median ORR from net MEDD to TDF (in mg per day) was 0.01 (range, -0.02 to 0.04), and the correlation coefficient of the TDF dose to the net MEDD was 0.77 (P < .0001). The ORR was not significantly impacted by body mass index or serum albumin. The ORR of 0.01 suggests that an MEDD of 100 mg is equivalent to 1 mg TDF daily or approximately 40 micrograms per hour of TDF (1000 micrograms/24 hours). CONCLUSIONS: The median ORR from MEDD to TDF in mg per day was 0.01. These results warrant further studies.

Effects of Dexamethasone and Placebo on Symptom Clusters in Advanced Cancer Patients: A Preliminary Report.

OBJECTIVE: Advanced cancer patients frequently experience debilitating symptoms that occur in clusters, but few pharmacological studies have targeted symptom clusters. Our objective was to examine the effects of dexamethasone on symptom clusters in patients with advanced cancer. METHODS: We reviewed the data from a previous randomized clinical trial to determine the effects of dexamethasone on cancer symptoms. Symptom clusters were identified according to baseline symptoms by using principal component analysis. Correlations and change in the severity of symptom clusters were analyzed after study treatment. RESULTS: A total of 114 participants were included in this study. Three clusters were identified: fatigue/anorexia-cachexia/depression (FAD), sleep/anxiety/drowsiness (SAD), and pain/dyspnea (PD). Changes in severity of FAD and PD significantly correlated over time (at baseline, day 8, and day 15). The FAD cluster was associated with significant improvement in severity at day 8 and day 15, whereas no significant change was observed with the SAD cluster or PD cluster after dexamethasone treatment. CONCLUSION: The results of this preliminary study suggest significant correlation over time and improvement in the FAD cluster at day 8 and day 15 after treatment with dexamethasone. These findings suggest that fatigue, anorexia-cachexia, and depression may share a common pathophysiologic basis. Further studies are needed to investigate this cluster and target anti-inflammatory therapies.