Zhanni Lu

Frequency, predictors, and outcomes of urine drug testing among patients with advanced cancer on chronic opioid therapy at an outpatient supportive care clinic

Data are limited on the use and outcomes of urine drug tests (UDTs) among patients with advanced cancer. The main objective of this study was to determine the factors associated with UDT ordering and results in outpatients with advanced cancer.

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.

Predicting the Risk for Aberrant Opioid Use Behavior in Patients Receiving Outpatient Supportive Care Consultation at a Comprehensive Cancer Center: Aberrant Drug Behavior in Cancer

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.

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.

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.

Effects of high-dose Asian ginseng (Panax ginseng) to improve cancer-related fatigue: Results of a double-blind, placebo-controlled randomized controlled trial.

209 Background: Cancer related fatigue (CRF) is the most common and disabling symptom in cancer.Panax ginseng extract (PG) is frequently used as a nutraceutical treatment for fatigue. There are no well-powered placebo-controlled trials that used validated CRF outcome measures to investigate of PG effects in cancer patients. The primary objective of this trial was to evaluate the effects oral PG versus Placebo (PL) for CRF. METHODS Patients with cancer fatigue ≥ 4/10 on Edmonton Symptom Assessment Scale (ESAS) were eligible. Patients were randomized to either 400mg of standardized PG or matching PL orally twice a day for 28 days. The primary endpoint was change in the Functional Assessment of Chronic Illness-Fatigue (FACIT-F) fatigue subscale from baseline to Day 28. Secondary outcomes were Functional Assessment of Cancer Therapy-General (FACT-G), Hospital Anxiety and Depression Scale (HADS), and ESAS. RESULTS Total evaluable patients were 112 (56 for PG and PL groups). No significant differences in baseline characteristics between the two groups except cancer type (p = 0.002). There was significant improvement in FACIT fatigue and ESAS fatigue scores in PG and PL groups at Day 15 and Day 29. The mean (SD) of FACIT-F fatigue scores at baseline, Day 15, and Day 29 were 22.6 (10.4), 29.8(10.7), 30.1 (11.6) and 23.8 (9.1), 30.0 (10.1), 30.4 (11.6) for PG and PL respectively. Mean (SD) improvement in the FACIT-F subscale at Day 29 was not significantly different in PG than in the PL group [7.5 (12.7) vs 6.5 (9.9), P = 0.67]. Mean (SD) improvement in the ESAS fatigue, FACT-G, and HADS at Day 29 were also not significantly different in PG than in the PL group. In a multiple linear model analysis, the change in FACIT-F fatigue from Day 0 to Day 29 was negatively correlated with baseline FACIT-F fatigue (p = 0.0005), baseline HADS score (p = 0.032), and male gender (p = 0.023). There were a significantly higher number of any grade of toxicities in PL group than in PG group (33/62 vs. 28/64, p = 0.024). CONCLUSIONS Both PG and Placebo result in a significant improvement in CRF at Day 15 and Day 29. PG was not significantly superior to placebo after 4 weeks of treatment. Further studies are needed. CLINICAL TRIAL INFORMATION NCT01375114.

Changes in opioid type and dose among cancer patients referred to outpatient palliative care.

106 Background: Opioid prescriptions are regulated at both federal and state levels. Examples of such regulations include use of risk evaluation and mitigation strategies (REMS), mandatory sharing of prescription data with state prescription drug monitoring programs and the reclassification of hydrocodone as schedule II opioid in October 2014. One possible consequence of such changes would be earlier referral to palliative care (PC) for opioid management. Alternatively, primary oncologist may treat patients with weak opioids or use strong opioids with lower daily dose. We hypothesized that during the last six years, the number of referrals to outpatient PC has increased and the morphine equivalent daily dose (MEDD) has decreased. METHODS We reviewed 750 randomly selected patients who were seen as a new consultation from the year 2010 to 2015. Data was collected on demographics, cancer type and stage, referring specialty, symptom assessment, cancer pain classification, performance status, opioid type and MEDD. Data were also collected on first subsequent PC visit among eligible patients. MEDD over the 6 years was evaluated using general linear regression method, adjusted for covariates. RESULTS Hydrocodone was the most common opioid prescribed by the referring team throughout the six-year period. After reclassification, its use declined from 43% in 2014 to 33% in 2015. Tramadol use increased from 9% in 2014 to 19% in 2015 (p < 0.0001). Median MEDD upon referral was 78mg/day in 2010 and progressively decreased to 40mg/day in 2015 (p < 0.0001). Year to year referral increased 24% in the first quarter of 2015 (after hydrocodone rescheduling), compared to 17% in 2014 (p 0.0014). CONCLUSIONS Over the past 6 years, there has been an increase in number of referrals to PC and a decline in MEDD upon referral. Likewise, an increase in weak opioids like tramadol has also been observed. These findings suggest oncologists are sending early referrals before further opioid dose titration and rotations are considered. Further opioid regulations will likely impact the integration of PC services in comprehensive cancer care.

Frequency, types of interventions and changes in symptoms after consultation with Rapid Access Supportive Care Clinic (RASCC).

153 Background: ASCO recommends an integration of palliative care to oncology care so as to improve outcomes. Recognizing the importance our center created a pilot RASCC. The aim of the study was to determine the most frequent interventions by RASCC and symptom change at first follow-up visit. METHODS In this retrospective study all patients seen as a part of RASCC clinic (August 2012- June 2013) were reviewed. Pts with stage 4 NSCLC with oncologist estimated survival of ≤ 6 months were eligible. Delivery of standardized palliative care was ensured using Palliative Care Checklist and weekly meetings. Care followed a standardized management plan. RESULTS 156 patients were evaluable. The median age was 63, 56% were male, 74% were white. SDS scores improved at follow-up (Table 1). The most common interventions were counseling (including advance cancer planning), medication changes. At the initial consultation, all patients received counseling n = 176 (pts received counseling by more than one IDT member); among the medications, dose initiation and increase of analgesics/opioids n = 122, laxatives n = 123, antiemetics 66, appetite stimulants 18, corticosteroids 10, antidepressants 9, methylphenidate 8, gabapentin 8, neuroleptics 5, sedatives 0. Among analgesics, dose initiation/increased morphine, n = 53, hydrocodone 24, oxycodone 18, hydromorphone12, methadone and fentanyl 6, codeine 1, NSAIDS3. CONCLUSIONS RASCC was associated significant improvement of symptoms and SDS scores at 1st follow-up and the most common interventions were counseling, medication changes related to pain. Further studies are needed. [Table: see text].

Characteristics of patients referred to embedded rapid access supportive care clinic.

141 Background: ASCO recommends Palliative care and Oncology integration to improve quality care outcomes. There is limited data on the patient (pt) characteristics (PC) for those who access integrated care. Our center created a pilot rapid access supportive care clinic (RASCC) to facilitate same-day consultation. The aim of this study was to determine the PC of pts referred (R) and not referred (NR) to RASCC. We also examined the PC of those who referred early[ER] (within 12 weeks of diagnosis or registration) vs those who have referred late [LR]. METHODS We reviewed pt medical records of all pts R and NR during the pilot period (Aug 01, 2012 to June 30, 2013). To be eligible all pts had advanced Stage IV non-small cell lung cancer with oncologist estimated overall survival (OS) of ≤ 6 months. RESULTS Of a total of 419 eligible pts seen at the thoracic oncology clinic, 157 (37%) pts were referred to RASCC. R group had a higher symptom distress scores, SDS (Table 1), weight loss, worse PS and OS compared to NR. There was no difference in PC between ER and LR except in the ESAS symptoms and SDS scores were higher in ER than LR, 40(29.5,52) vs 31.5(22.25,40.125), P < .001. CONCLUSIONS R pts had higher symptom burden and worse OS. Similarly ER had a higher SDS than LR suggesting referrals to RASCC were primarily based on symptom burden. [Table: see text].