Edmonton Symptom Assessment Scale Symptoms Research Articles

Alleviating breathlessness in patients with cancer with dexamethasone (ABCD): A parallel-group, double-blind, randomized clinical trial (RCT).

12112 Background: Systemic corticosteroids are commonly prescribed for palliation of dyspnea in patients with cancer; however, evidence to support their use is limited. A small RCT suggested that dexamethasone may be efficacious. In this confirmatory RCT, we compared the effect of high dose dexamethasone and placebo on dyspnea in patients with cancer. Methods: This NCI-funded, multi-site, double-blind, parallel group RCT enrolled ambulatory patients with cancer, age ≥18, dyspnea ≥4/10 and randomly assigned them to receive dexamethasone 8 mg orally every 12 hours for 7 days followed by 4 mg orally every 12 hours for 7 days or matching placebo capsules. Permuted block randomization (block size = 6, 2:1) was conducted, stratified by baseline dyspnea and study site. Patients, research staff and clinicians were blinded. The primary outcome was change in average dyspnea intensity assessed with a 0-10 numeric rating scale (0 = none, 10 = worst) between baseline and day 7. Secondary outcomes included the Edmonton Symptom Assessment Scale (ESAS) and adverse effects (CTCAE v4.02). Intention-to-treat analysis was conducted with linear models to compare between groups. The planned sample size of 201 patients provided 80% power to detect a mean difference of 1.0 between treatment groups with a two-sided α of 5%, assuming a standard deviation of 2.0 and 15% attrition. (Clinicaltrials.gov NCT03367156). Results: Between 1/11/2017 and 4/23/2021, we enrolled 149 patients and 128 received the blinded study interventions (dexamethasone n = 85, placebo n = 43). Enrollment was terminated early by the Data Safety Monitoring Board when futility criterion was met in pre-planned interim analysis. The mean change in dyspnea NRS intensity between baseline and day 7 was -1.6 (95% CI -2, -1.2) in the dexamethasone group and -1.6 (95% CI -2.3, -0.9) in the placebo group, with no significant between-group difference (mean 0, 95% CI -0.8, 0.7; P = 0.91). Secondary analyses showed that the dexamethasone group had a significantly better ESAS appetite (mean difference -1.2, 95% CI -2.2, -0.1; P = 0.03) and well being (mean -1, 95% CI -1.8, -0.2; P = 0.02), and worse ESAS anxiety (mean 1.1, 95% CI 0.3, 1.9; P = 0.01) and depression (mean 0.9, 95% CI 0.1, 1.7; P = 0.02) compared to placebo. Similar magnitude of changes in dyspnea and ESAS symptoms were observed by day 14. Adverse effects were reported more frequently in the dexamethasone group (any grade): insomnia (38% v. 12%), neuropsychiatric symptoms (31% vs. 7%), infections (21% v. 12%), dyspepsia (26% v. 12%), edema (18% v. 9%), hiccups (12% v. 7%), flushing (9% v. 5%) and respiratory distress (6% v. 0%). More patients in the dexamethasone group required hospitalization within 30 d of last study medication (25% vs. 7%, P = 0.02). Conclusions: High dose dexamethasone did not improve dyspnea in patients with cancer more than placebo and was associated with more adverse events. Clinical trial information: NCT03367156.

Symptoms, performance status and quality of life in cancer patients receiving palliative care

Aim: The aim of the study was to describe the symptoms experienced by cancer patients receiving palliative care, patients’ performance and the effects on their quality of life. Materials and Methods: This is a descriptive study and was conducted with 106 patients admitted to palliative care unit at a university hospital in Izmir, located in the west of Turkey, between December 2019 and April 2020. For data collection, Patient Information Form, “Eastern Cooperative Oncology Group (ECOG) Performance Status Scale”, “Edmonton Symptom Assessment Scale (ESAS)” and “Functional Assessment of Chronic Illness Therapy-Palliative Care (FACIT-Pal) Scale” were applied. For data analysis, descriptive statistics, Chi-square test, Kruskall Wallis Analysis and linear regression analysis were used. Results: Patients reported that the most common symptoms experienced were fatigue, sense of being unwell, anxiety, sadness (depression) and pain. According to the regression analysis, there was a statistically significant difference between the total quality of life scores of the patients and pain, fatigue and nausea from the patients' ESAS symptoms. The quality of life scores were significantly lower in the patients who were hospitalized, had an advanced disease stage, did not have metastases or did not know their metastases status and had a low performance status ECOG. There was a statistically significant difference between patients' ECOG performance status and quality of life. Conclusion: Patients have multiple symptoms and poor quality of life. Our findings support the importance of symptom assessment and management to improve quality of life.

Yoga Therapy in Cancer Care via Telehealth During the COVID-19 Pandemic.

Yoga is an evidence-based mind-body practice known to improve physical and mental health in cancer patients. We report on the processes and patient-reported outcomes of one-on-one yoga therapy (YT) consultations delivered via telehealth. For patients completing a YT consultation between March 2020 and October 2021, we examined demographics, reasons for referral, and self-reported symptom burden before and after one YT session using the Edmonton Symptom Assessment Scale (ESAS). Changes in ESAS symptom and subscale scores [physical distress (PHS), psychological distress (PSS), and global distress (GDS)] were evaluated by Wilcoxon signed-rank test. Descriptive statistics summarized the data. Ninety-seven initial YT consults were completed, with data evaluated for 95 patient encounters. The majority were women (83.2%) and white (75.8%), The mean age for females was 54.0 and for males was 53.4; the most common diagnosis was breast cancer (48%), 32.6% had metastatic disease, and nearly half (48.4%) were employed full-time. Mental health (43.0%) was the most common reason for referral, followed by fatigue (13.2%) and sleep disturbances (11.7%). The highest symptoms at baseline were sleep disturbance (4.3), followed by anxiety (3.7) and fatigue (3.5). YT lead to clinically and statistically significant reductions in PHS (mean change = -3.1, P < .001) and GDS (mean change = -5.1, P < .001) and significant reductions in PSS (mean change = -1.6, P < .001). Examination of specific symptom scores revealed clinically and statistically significant reductions in anxiety (mean change score -1.34, P < .001) and fatigue (mean change score -1.22, P < .001). Exploratory analyses of patients scoring ≥1 for specific symptoms pre-YT revealed clinically and statistically significant improvements in almost all symptoms and those scoring ≥4 pre-YT. As part of an integrative oncology outpatient consultation service, a single YT intervention delivered via telehealth contributed to a significant improvement in global, physical, and psychosocial distress. Additional research is warranted to explore the long-term sustainability of the improvement in symptoms.

Abstract PD12-10: Patient reported outcomes and health care utilization of UPMC breast cancer survivorship clinic patients

Abstract Background. The number and longevity of cancer survivors is growing due to aging of the population, improving cancer treatments, and earlier detection. The Institute of Medicine has recommended creation of guideline-concordant models of cancer survivorship care and clinics for this growing population with unique needs. There is currently little data on how cancer survivors seen at a survivorship clinic fare compared to those seen in routine oncology clinics in terms of quality of life and health care utilization. At the University of Pittsburgh Medical Center (UPMC), we performed a descriptive analysis of healthcare utilization and patient reported outcomes (PROs) of cancer survivors seen at survivorship clinic compared to at oncology clinics. Methods. The population consisted of breast cancer patients who received care at UPMC survivorship or oncology clinics (control) between January 2012 and December 2018. PROs were collected at each clinic visit and included the SF-12, the Edmonton Symptom Assessment Scale (ESAS), Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) scales. Cancer diagnoses and staging were obtained from the UPMC Network Cancer Registry. Patient demographics, mortality, ED visits and inpatient stays were extracted from the electronic medical record. ED utilization and inpatient admissions were examined one-year prior to survivorship care compared to 90-days after the start of survivorship care. Categorical and continuous data were examined by Wilcoxon rank sum tests and likelihood-ratio chi-squared tests, respectively. A p-value &amp;lt;0.05 was considered statistically significant. Results. Data from 680 cancer survivors were included, of which 285 patients received their follow-up care in survivorship clinic and 395 patients received their follow up care in oncology clinics. Baseline demographics were comparable between the two groups, except survivorship clinic patients (SCPs) had higher 1-year mortality (3.5% vs. 0.5%, p=0.003) and cancer stage (62% vs. 48% ≥ stage II, p=0.044). SCPs had significantly more ED visits at baseline and their number of ED visits remained higher than control once enrolled in survivorship clinic, although this trended down after 90 days in survivorship clinic (table 1). Inpatient visits were significantly increased for SCPs as compared to controls at 90 days after enrollment in survivorship clinic (6.4% with ≥ 1 inpatient admission vs. 1.8%, p=0.003). SCPs had consistently worse PROs compared to controls. Prior to enrolling in survivorship clinic, SCPs had higher rates of moderate to severe depression (22.4% with PHQ-9 score of 10-24 vs. 7.8%, p=0.002) and anxiety (20.6% with GAD-7 scores of 10 - 21 vs. 9.2 %, p&amp;lt;0.001) and this remained elevated at all time points compared to controls, although these rates appeared to decrease over time. SCPs also rate their overall health lower than controls on the SF-12 and they have higher symptom severity across most ESAS symptoms. Conclusions. Cancer survivors who are referred to and receive care in survivorship clinic have poorer quality of life and higher health care utilization at baseline and over time when compared to patients who receive care in oncology clinics. This observation suggests that survivorship clinics may be seeing cancer survivors with higher symptom burden and health care needs. This warrants future efforts to better understand, support, and prevent morbidity of survivorship clinic patients. Table 1. ED and Hospital Utilization Among Survivorship Clinic Patients and Controls.Pre-Survivorship ClinicAfter Enrollment in Survivorship Clinic1 Year90 Days# ED VisitsControl (%)Survivorship (%)PControl (%)Survivorship (%)P0345 (87.3)199 (69.8)&amp;lt;0.001382 (96.7)250 (87.7)&amp;lt;0.0011+50 (12.7)86 (30.2)13 (3.3)35 (12.3)# Inpatient Admissions0319 (80.8)225 (79.0)0.341388 (98.2)267 (93.7)0.0031+76 (19.3)60 (21.0)7 (1.8)18 (6.4) Citation Format: Kristine Gade, Stefanie C. Altieri Dunn, Ellen Ormond, Andrew Bilderback, Jill W Brufsky, Emily M. Geramita, G J van Londen. Patient reported outcomes and health care utilization of UPMC breast cancer survivorship clinic patients [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr PD12-10.

Utilizaton of patient reported outcomes measures (PROM) to characterize symptom burden and adherence associated with oral oncolytic therapy.

210 Background: The use of patient reported outcome measures (PROMs) to monitor cancer treatment tolerability has been shown to positively impact outcomes. The purpose of this study was to characterize the incidence and severity of side effects, patient self-management confidence, and medication adherence in patients receiving oral oncolytic therapy. Methods: This multicenter, cross-sectional, observational study was conducted across 6 Michigan oncology practices from July 2016-December 2018. Patients were eligible to complete PROMs during the course of their treatment if they were receiving an oral oncolytic medication (excluding endocrine therapy). Results: There were a total of 2252 PROMs completed in 695 patients. Patients were 48% female, a median age of 69 years, and most commonly receiving treatment with capecitabine (18%), palbociclib (10%), and lenalidomide (9%). 54% of PROMs had at least one Edmonton Symptom Assessment Scale (ESAS) symptom rated as moderate or severe. Patients indicated the presence of a most bothersome symptom (MBS) in 35% of PROMs. Most common MBSs were fatigue (26%), pain (16%), constitutional symptoms other than fatigue (15%), and nausea/vomiting (14%). Non-adherence was reported in 20% of PROMs. ESAS symptoms rated as moderate or severe, the presence of a MBS, and lower confidence scores all correlated with medication non-adherence. Conclusions: Patients taking oral oncolytics for their cancer treatment experience a high symptom burden with more than 50% experiencing a moderate to severe symptom. Optimizing symptom management and providing patient education that increases patient confidence in self-management may improve medication adherence and patient outcomes.

MEASUREMENT-BASED CARE: CAN TOOLS FROM PALLIATIVE CARE INFORM OUR PRACTICE IN GERIATRIC MENTAL HEALTH?

Introduction Measurement-based care, which encompasses the use of self-report scales for tracking patients’ responses to treatment, has been systematically reviewed in the context of primary care where it has been shown to enhance communication between providers and patients1. Among older adults with mood disorders, pain and somatic symptoms are common and often under-recognized2,3. Scales for monitoring mood, anxiety and physical symptoms have been well validated in older adults with psychiatric disorders within inpatient and outpatient settings. In the palliative care context, the Edmonton Symptom Assessment Scale (ESAS) and the Patient Dignity Inventory (PDI) are commonly used to track burden of symptoms and impact of illness on dignity. We explore the utility and relevance of using self-rating scales as part of a measurement-based care initiative in geriatric mental health at Baycrest, an academic health sciences centre in Toronto, Canada. We examine the relationship between depression, anxiety and somatic symptoms and introduce the use of the ESAS and PDI in a non-palliative care context. 1) Wray LO et al. Enhancing implementation of measurement-based mental health care in primary care: a mixed-methods randomized effectiveness evaluation of implementation facilitation. BMC Health Serv Res. 2018; 18: 753. 2) Chodosh J, Solomon DH, Roth CP et al. The quality of medical care provide to vulnerable older patients with chronic pain. J Am Geriatric Soc. 2004; 52:756-761. 3) Meeks TW, Dunn LB, Kim DS et al. Chronic Pain and Depression among geriatric psychiatry inpatients. Int J of Geriatr Psychiatry. 2008; 23:637-642. Methods Participants were recruited from an inpatient geriatric mental health unit and an outpatient day hospital for mood and related disorders. Self-report rating scales tracking mood, anxiety and somatic symptoms were completed, including the Geriatric Depression Scale (GDS), Geriatric Anxiety Inventory (GAI), the ESAS and the PDI. Demographic characteristics were gathered from a retrospective chart review. Inpatient and outpatient groups were compared using Fisher's exact test for categorical variables and Wilcoxon tests for continuous variables. Longitudinal cross-sectional models used generalized estimating equations and an exchangeable working correlation (WC) matrix to adjust for repeated measures within patient across time. Cross-sectional models including time-varying covariates measured concurrently with the outcome and were adjusted for baseline values for age, number of comorbidities and medications and level of cognition. Results Data were obtained for 33 English speaking patients (inpatients N=17, outpatients N=16) with a mean age of 76.5 (SD=6.1), 69.7 % female and 48.5% married. Inpatients had a significantly higher number of comorbidities than outpatients. Self-reported scales were measured from 1 to 17 weeks (mean number of weeks was 8.2, SD=4.7). At baseline, prevalence of moderate to severe ESAS symptoms (4 or higher score) ranged from 19% to 75% (Table 1). Higher GDS scores were significantly correlated with self-ratings for poor dignity and high anxiety (p GDS and PDI scores had a similar pattern to the mean ESAS pain item score across time (Figure 1). Mean scores for all the scores increased indicating worse scores for those remaining under follow up. Some example longitudinal modelling results are as follows: GDS scores decreased over time but less rapidly for patients reporting a higher degree of pain (p=0.02, WC=0.80). PDI scores decreased across time but higher PDI scores were associated with higher ESAS drowsiness (p=0.002, WC=0.82). Conclusions Self-report scales yielded relevant clinical information including the high physical symptom burden experienced by older adults in geriatric mental health inpatient and outpatient settings. This study suggests there is value in using self-report rating scales to track mood, anxiety, dignity, pain and other symptoms. Measurement-based care can create a dialogue between patient and clinician about symptom variability over time, and its usage in geriatric psychiatry warrants further exploration. In our study, there was an association between subjective distress experienced by participants and underlying pain. Over time, Geriatric Depression Scale scores tended to remain elevated for patients who simultaneously reported higher pain. As well, the Edmonton Symptom Assessment Scale was highly correlated across time with the GDS. Incorporating a palliative care lens may suggest new approaches to care and have relevance to inpatient and outpatient geriatric mental health settings where burden of symptoms is high. While our study is limited by its small sample size, the use of self-report scales commonly used in palliative care within a geriatric mental health context merits replication in other settings. This research was funded by A stipend was provided by Baycrest's Department of Psychiatry's Academic Development Fund.

Improving the measurement of clinician response to symptom screening: Auditing the symptom management of cancer patients in Ontario.

218 Background: Since 2007, Cancer Care Ontario has provincially mandated symptom screening of cancer patients using the Edmonton Symptom Assessment Scale (ESAS). Screening rates are the primary performance metric used across 14 Regional Cancer Centres (RCCs), however this indicator does not detail how symptoms are managed during the clinic visit. The objective is to share our accomplishments using a chart audit process and share upcoming changes aimed to improve the measurement of clinician response to symptom screening. Methods: The initial chart audit tool was created by regional stakeholders who oversee cancer symptom management. The tool measures the concordance between clinician response to the patient symptom screen and best practices outlined in the Cancer Care Ontario Symptom Management Guides. RCCs conduct an annual chart audit for seven of the ESAS symptoms, and sample at least 20 patients with high symptom scores (&gt;=4). Chart documentation is analyzed to determine whether the patient received appropriate assessment and interventions. Results: 7,952 chart audits have been completed since 2012. Patients reporting symptom burden in FY 2015/16 often received an assessment (72-93%) and intervention (48-79%) during the clinic visit, depending on the symptom. Annual provincial aggregate results are intended to support quality improvement, inform clinician symptom management education, and provide a snapshot of resource utilization. Shortcomings of the audit have been identified over time. These highlight the need for more actionable items and a standardized process to ensure representative sampling, as aggregate results can be biased when RCCs co-opt the audit to measure local projects. This prompted an overhaul of the audit process: new audit tool created; results linkable to administrative data; and objectives clearly defined to balance local and provincial needs. Conclusions: Measuring the frequency of symptom screening is important, but the most clinically relevant question is whether the patient’s symptoms are being managed. Changing the chart audit process will ease the burden on auditors, improve data quality, and ensure data utility at all levels.

Characteristics of patients with unscheduled versus scheduled visits to outpatient supportive care center (SCC) at a comprehensive cancer center.

144 Background: There is limited literature regarding outpatient palliative care, and even more limited literature describing factors associated with unscheduled visits. Our aim was to identify clinical characteristics of patients who walk-in (present unscheduled) to the outpatient SCC with the hypothesize that the patients who present for unscheduled visits have more severe symptom distress as compared to those patients who present for scheduled appointments. Methods: We compared 183 patients with unscheduled consults (CO) vs a random sample of 361 patients with scheduled CO and 159 patients with unscheduled follow-up (FU) visits vs a random sample of 318 patients with scheduled FU visits. Results: Among 544 total CO visits, unscheduled visits had worse median Edmonton Symptom Assessment Scale (ESAS) symptoms (on a scale from 0 to 10): pain (6.5 vs 4.7, p &lt; .0001), fatigue (p = .002), nausea (p = .017), depression (p = .003), anxiety (p = 0.02), sleep (p = .0002), and overall feeling of well-being (p = 0.0009). There was no statistical difference in shortness of breath, financial distress, nor spiritual pain. Daily opioid dose (MEDD in mg) was significantly higher in unscheduled CO visits (119.7 vs 62.9, p = .0004). Among 344 total FU visits, unscheduled visits had worse median ESAS symptoms: pain (5.7 vs 4.2, p = .0001), fatigue (p = .0006), depression (p = .019), anxiety (p = .014) and higher MEDD (111.3 vs 73.6, p = .0009). There was no difference in type of insurance coverage and better ECOG (p = .015) in unscheduled vs scheduled CO visits. Unscheduled CO visits were more likely to be from outside the Houston area (161/361, 45% vs. 40/133, 30%, p &lt; 0.0001). Conclusions: Patients who are either referred as unscheduled CO visits or who present as unscheduled FU visits have higher levels of physical and psychosocial distress and higher opioid dose. Outpatient palliative care centers need to provide opportunity for walk-in referrals for timely management of these issues.

Integrative oncology consultation and symptom palliation: Analysis of patient-reported outcomes at a comprehensive cancer center.

84 Background: Patients (pts) receiving cancer care are increasingly interested in complementary health approaches to improve symptoms and quality of life. We report on demographics and patient reported outcomes in an integrative oncology (IO) clinic. Methods: Pts presenting for IO consultation or follow-up completed: Measure Yourself Concerns and Wellbeing (MYCaW), Edmonton Symptom Assessment Scale (ESAS), Short Form 12 (SF-12) quality of life (QOL) scale, and an overall satisfaction questionnaire. Consultations were provided by medical oncologists. Results: 2,474 consultations were conducted from 9/2009 to 12/2013; 26.0% (n = 643) had ≥ 1 follow-up visit (mean 3.2; SD1.8). Most were female (69%) and white (75%); most frequent cancer types was breast (29%); 29% of pts had advanced disease. At baseline, ESAS scores were highest for Sleep (4.2; SD 2.8), Fatigue (4.0; SD 2.8), Well-Being (3.8 SD 2.6) and Anxiety (3.1; SD 2.9). Those with advanced disease had significantly higher baseline ESAS scores for pain, nausea, shortness of breath, and appetite; higher ESAS subscale scores for physical and global distress; lower SF-12 physical health scores; and were more interested in developing an integrative/holistic approach and appetite. Those with loco-regional disease were more interested in overall health, hot flashes, and dry mouth. For ESAS baseline scores ≥ 4 and follow up within 30 days of the initial consult, we observed overall improvement in ESAS symptoms (38-60% of pts with ESAS decrease ≥ 1). Overall satisfaction was high at both initial encounter (9.4; SD 1.3) and first follow up (9.5; SD 1.2). Patients were satisfied to very satisfied with how well MYCaW concern 1 and 2 were addressed: 8.0 (SD 2.2) and 9.1 (SD 1.8). No difference in overall satisfaction was observed comparing those with advanced vs loco-regional disease. Conclusions: Most pts presenting for integrative oncology consultation have early stage disease, relatively low symptom burden, and are most interested in support for overall health. Patients were overall very satisfied with how well their top concerns were addressed, with significant improvements in symptom distress.

Hope, Symptoms, and Palliative Care.

Hope is important to patients with cancer. Identifying factors that influence hope is important. Anxiety, depression, fatigue, and pain are reported to impair hope. The objective of this study was to determine whether age, gender, marital status, duration of cancer, symptoms, or symptom burden measured by the sum of severity scores on the Edmonton Symptom Assessment Scale (ESAS) correlated with hope measured by the Herth Hope Index (HHI). Patients with advanced cancer in a palliative care unit participated. Demographics including age, gender, marital status, cancer site, and duration of cancer were collected. Individuals completed the ESAS and HHI. Spearman correlation and linear regression were used to assess associations adjusting for gender (male vs female), age (< 65 vs ≥ 65 years), marital status (married or living with a partner vs other), and duration of cancer (≤ 12 vs > 12 months). One hundred and ninety-seven were participated in the study, of which 55% were female with a mean age of 61 years (standard deviation 11). Hope was not associated with gender, age, marital status, or duration of cancer. In univariable analysis, hope inversely correlated with ESAS score (-0.28), lack of appetite (-0.22), shortness of breath (-0.17), depression (-0.39), anxiety (-0.32), and lack of well-being (-0.33); only depression was clinically relevant. In multivariable analysis, total symptom burden weakly correlated with hope; only depression remained clinically significant. This study found correlation between symptom burden and hope was not clinically relevant but was so for depression. Among 9 ESAS symptoms, only depression had a clinically relevant correlation with hope.

Predictors of response to palliative care intervention for chronic nausea in advanced cancer outpatients.

Nausea is a frequent and distressing symptom in advanced cancer patients. The objective of this retrospective study was to determine predictors of response to palliative care consultation for chronic nausea in advanced cancer outpatients. Eligible patients included were outpatient supportive care center seen consecutively for an initial consultation and who had one follow-up visit within 30 days of the initial consultation. We reviewed the medical records of 1,273 consecutive patients, and 444 (35 %) were found to meet the eligibility criteria. All patients were assessed using the Edmonton Symptom Assessment Scale (ESAS). Nausea response was defined as an improvement of at least 30% between the initial visit and the first follow-up. We used logistic regression models to assess the possible predictors of improvement in nausea. Overall, 112 of 444 patients (25%) experienced moderate/severe chronic nausea (ESAS item score ≥4/10). Higher baseline nausea intensity was significantly related to constipation (r = 0.158; p = 0.046) and all the symptoms assessed by the ESAS (p < 0.001). Sixty-eight of the 112 (61%) patients with moderate/severe nausea at baseline showed a significant improvement at the follow-up visit (p < 0.001). The main predictors for nausea response were improvement of fatigue (p = 0.005) and increased appetite (p = 0.003). Baseline nausea was associated with all the ESAS symptom and improvement of fatigue and lack of appetite predicted a lower frequency of nausea at follow-up. More research is necessary to better understand the association between nausea severity and other symptoms and to predict which interventions will yield the best outcomes depending on the mix and severity of symptoms.

1631 - Phyisical and Emotional Symptoms in Patients with Solid and Haematologic Malignancies Without Metastases, On Cure or Follow-Up: Are They Overlapping?

ABSTRACT In a prospective study carried out on 88 patients with solid cancer on cure and 20 on follow up (Group A) and 86 patients with haematologic malignancies (68 on cure) (Group B), we assessed the presence and intensity of physical and emotional symptoms through the Edmonton Symptom Assessment Scale (ESAS). In both groups, whereas no correlation was observed between age or religiousness and ESAS symptoms, a score above the clinical cut off for HADS (10/11) was associated with higher intensity of almost all symptoms. Drowsiness was less reported by patients with HADS 90 for group A only. Whereas, for group B the associations with low KPS were for uncontrolled anorexia, not-well being and dyspnoea (p = 0.002; p = 0.029; p = 0.018 respectively). In both groups patients with higher proportion of uncontrolled depression or drowsiness were significantly associated to receiving psychological support. Pain, anxiety and not-well being were correlated with psychological support for group A only. We believe that the routinary assessment of physical and emotional symptom in patients with both malignancies is mandatory to recognize all the symptoms with a particular attention to the emotional ones. Phyisical and emotional symptoms in patients with solid and haematologic malignancies without metastases, on cure or follow-up: are they overlapping? Disclosure All authors have declared no conflicts of interest.

1617 - Edmonton Symptom Assessment Scale (ESAS) For Routine Symptom Assessment of Non-Advanced Patients with Solid or Haematological Malignancies on Oncological Therapies

ABSTRACT The Edmonton Symptom Assessment Scale (ESAS) was developed for use in daily symptom assessment of palliative care patients. We used the ESAS validated version in Italian Language to assess the presence and intensity of symptoms (not at all = 0; mild 1-4, not controlled ≥5) in 108 patients with solid and 86 with haematologic malignancies and no metastases, on active oncological treatments (156 patients) or during follow-up. In haematologic group, dyspnoea was ≥ 5 in 12% of the patients in respect to 3% of solid tumour group (chi2 test, p = 0.002). Not controlled fatigue, drowsiness and dyspnoea were significantly more frequent in patients on cure (p = 0.041; p = 0.026; p = 0.010 respectively). The intensity of all the symptoms was higher in patients with a KPS of 70-90 in respect to those with KPS > 90, and in patients above the clinical HADS cutoff (10/11) in respect to those below. The intensity of psychological suffering was higher for patients who requested psychological support. The correlation (rho of Pearson) between the anxiety and depression items of ESAS with HADs was >.5, whereas the feeling of well- being in ESAS inversely strongly correlated with all the other ESAS symptoms (rho > .4); anorexia with nausea and drowsiness; drowsiness with fatigue; and anxiety with depression. As the ESAS assesses the most frequent symptoms referred to by the patients during oncological treatments, its administration to the patients in the routine practice before each visit with the oncologist can give him/her the information on the presence and intensity of physical and emotional symptoms. Disclosure All authors have declared no conflicts of interest.

Frequency, indications, outcomes, and factors associated with successful opioid rotation in cancer patients presenting to an outpatient supportive care center.

e19599 Background: Opioids are first line medications for cancer pain. Opioid rotation (OR) is recommended for uncontrolled cancer pain (UCP) and opioid induced neurotoxicity (OIN). Limited data exist on frequency, indications and outcomes of OR in ambulatory cancer patients in outpatient setting. Methods: We reviewed consecutive outpatient visits to the Supportive Care Center in 2008 for OR. Data regarding demographics, Edmonton Symptom Assessment Scale (ESAS), Memorial Delirium Assessment Scale, pain characteristics, opioid use, indication for OR, outcomes, morphine equivalent daily dose (MEDD) and supportive counseling was collected in all patient visits who followed up within 5 weeks of OR. Successful OR was defined as a 2 point or 30% reduction in ESAS symptom score, resolved symptoms of OIN and continuation of new opioid at follow up. Stepwise logistic regression analysis was performed to determine factors associated with successful OR. Results: 244/2471(10%) patient visits had OR and 142 (58%) were followed up within 5 weeks. 40% (57/142) were consult visits. 74% (105/142) were white, 60% (85/142) male. Median age and performance status were 55 and 1. GI (24%) and lung (22%) were the most common cancer types with 77% (110/142) advanced cancer. Median time (Q1-Q3) between OR and follow up was 14 (7-21) days. Most common indications for OR were UCP 82% and OIN 13%. 34% had partial OR and 16% had more than one reason for OR. Pain characteristics were 49% nociceptive, 21% mixed and 11% neuropathic. Median (Q1-Q3) pain and symptom distress score improved: -2 (-4-0, P=.003) and -5 (-14-7, P=.004). Median MEDD (Q1-Q3) decreased from 162 (90-287) to 156 (90-280, P=.82). 66% (94/142) had successful OR. Fentanyl (34%) before and Methadone (55%) after OR were most common opioids. 17% (24/142) had another OR at follow up visit. High MEDD (P=.05) prior to OR was associated with successful OR. Conclusions: 10% of outpatient visits had OR with a 66% success rate in treating UCP and OIN. Further research is needed to determine predictors of successful OR.

Symptom Burden, Medication Detriment, and Support for the Use of the 15D Health-Related Quality of Life Instrument in a Chronic Pain Clinic Population

Chronic noncancer pain is a prevalent problem associated with poor quality of life. While symptom burden is frequently mentioned in the literature and clinical settings, this research highlights the considerable negative impact of chronic pain on the individual. The 15D, a measure of health-related quality of life (HRQOL), is a user-friendly tool with good psychometric properties. Using a modified edmonton symptom assessment scale (ESAS), we examined whether demographics, medical history, and symptom burden reports from the ESAS would be related statistically to HRQOL measured with the 15D. Symptom burden, medication detriment scores, and number of medical comorbidities were significant negative predictors of 15D scores with ESAS symptom burden being the strongest predictor. Our findings highlight the tremendous symptom burden experienced in our sample. Our data suggest that heavier prescription medication treatment for chronic pain has the potential to negatively impact HRQOL. Much remains unknown regarding how to assess and improve HRQOL in this relatively heterogeneous clinical population.

Symptom clusters in patients with advanced cancers

It has been observed that certain cancer symptoms frequently occur together. Prior research on symptom patterns has focused mainly on inpatients, early stage cancers, or a single cancer type or metastatic site. Our aim was to explore symptom clusters among outpatients with different advanced cancers. Symptom scores by the Edmonton Symptom Assessment Scale (ESAS) were routinely collected for patients attending the Oncology Palliative Care Clinics at Princess Margaret Hospital from January 2005 to October 2007. Principal component analysis (PCA) was performed for the entire patient cohort and within specific disease sites to determine inter-relationships of the nine ESAS symptoms. A total of 1,366 patients was included: 682 (50%) were male and 684 (50%) were female. The median age was 64 years (range 18 to 74 years). The most common primary cancer sites were gastrointestinal (27%), lung (14%), and breast (11%). The three most distressful symptoms were fatigue, poor general well-being, and decreased appetite. PCA of symptoms for the entire patient cohort revealed two major symptom clusters: cluster 1 included fatigue, drowsiness, nausea, decreased appetite, and dyspnea, which accounted for 45% of the total variance; cluster 2 included anxiety and depression, which accounted for 10% of the total variance. There was high internal reliability in the clusters (Cronbach's alpha coefficient approximately 0.80). PCA of symptoms within the various primary cancer sites revealed differences in the pattern of symptom clusters. In patients with advanced cancers, distinct symptom clusters can be identified, which are influenced by primary cancer site. Treatments directed at symptom clusters rather than individual symptoms may provide greater therapeutic benefit. Further prospective studies are warranted in order to develop more effective targeted palliative interventions for the advanced cancer patient population.

Symptom Clusters in Patients with Advanced-Stage Cancer Referred for Palliative Radiation Therapy in an Outpatient Setting

PurposeThe aim of this study was to explore the presence of symptom clusters in patients with advanced cancer. Patients and MethodsPatients with metastatic cancer referred to an outpatient palliative radiation therapy clinic were asked to rate their symptom distress using the Edmonton Symptom Assessment Scale (ESAS). Baseline demographic data were obtained. To determine interrelationships between symptoms, a principal component analysis with “varimax rotation” was performed on the 9 ESAS symptoms. ResultsBetween January 1999 and January 2002, a total of 1296 patients with metastases provided complete baseline data on the ESAS. The most common primary cancer sites were lung, breast, and prostate. Fatigue was the highest scored symptom, followed by poor sense of well-being, pain, lack of appetite, and drowsiness. The 4 most prevalent symptoms were poor sense of well-being (92.7%), fatigue (92.2%), drowsiness (79.7%), and anxiety (78.7%). Three symptom clusters were found. Cluster 1 included lack of appetite, nausea, poor sense of well-being, and pain. Cluster 2 included fatigue, drowsiness, and shortness of breath. Cluster 3 included anxiety and depression. ConclusionMore work needs to be done on symptom cluster research, especially in setting a consensus in methodology.

Symptom clusters in cancer patients with bone metastases

The purpose of this study is to explore whether bone pain "clusters" with other symptoms in patients with bone metastases. Patients with bone metastases referred to a palliative radiotherapy clinic were asked to rate their symptom distress using the Edmonton Symptom Assessment Scale (ESAS). Analgesic consumption during the previous 24 h was captured at initial consultation. To determine interrelationships between symptoms, a principal component analysis (PCA) with "varimax rotation" was performed on the nine ESAS symptoms. This study defined a "symptom cluster" as two or more symptoms that occur together, are stable, and are relatively independent of other clusters. Patients were followed 1, 2, 4, 8, and 12 weeks post-radiation treatment by telephone. Statistical analysis was performed at each time point for both responders and nonresponders to radiation (response was defined in accordance to the International Bone Metastases Consensus Working Party). Five hundred eighteen patients with bone metastases provided complete baseline data using the ESAS. The four most prevalent symptoms were poor sense of well-being (93.5%), fatigue (92.3%), pain (84.1%), and drowsiness (81.8%). Three clusters were identified and accounted for 66% of the total variance at baseline. Cronbach's alpha coefficient demonstrated high internal reliability in the clusters, with a coefficient ranging from 0.61 to 0.81. It was observed that the clusters changed post-radiation in both responders and nonresponders and that pain clustered with different symptoms (or remained a separate symptom in responders). In nonresponders, three symptom clusters were consistently present, except in week 8. Radiotherapy influenced the structure of symptom clusters in both responders and nonresponders. There was evidence that pain clustered out in responders of radiation to pain. It was found that pain clustered with fatigue, drowsiness, and poor sense of well-being at baseline. However, these findings must be heeded with caution, as more work is needed to clearly define symptom clusters and to understand the effects of radiation in the symptom experience of patients with bone metastases.

Gender Differences in Patient-Rated Symptoms Following Whole Brain Radiotherapy for Brain Metastases

AbstractGoals of Work. To examine if gender differences exist in patient-rated symptoms following whole brain radiotherapy for treatment of brain metastases.Patients and Methods. Patients with brain metastases treated with palliative whole brain radiotherapy were asked to rate their symptoms using the Edmonton Symptom Assessment Scale (ESAS) before, and 1, 2, 4, 8 and 12 weeks following treatment. The mean difference of each ESAS symptom at follow up was compared with the baseline value. Mean differences with a p value < 0.01 were considered statistically significant.Main Results. From January 1999 to January 2002 one hundred and seventy patients (102 female and 68 male) were accrued. The median age for males was 67 years (range 40–82) and 64 years for females (range 33–84). At baseline, there were no significant gender differences in age, symptomatology and Karnofsky Performance score. Following treatment, there was a statistically significant deterioration from the baseline for females in the following ...