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To examine the safety, effectiveness, and patient-perceived benefit of treatment with olanzapine for nausea and vomiting (N/V) in patients with advanced cancer. We conducted a multicenter prospective observational study in a tertiary care setting (Trial registration number: UMIN000020493, date of registration: 2016/1/12). We measured the following: average nausea in the last 24 h using a Numeric Rating Scale (NRS: range 0–10) at baseline and day 2, patient-perceived treatment benefit (based on a 5-point verbal scale), and adverse events (AEs; using the Common Terminology Criteria for Adverse Events version 4). The 85 participants (45% men) had a mean age of 58.7±15.8 years. Major causes of N/V were opioids (44%) and chemotherapy (34%). All patients received a daily dose of olanzapine of 5 mg or less as first-line treatment (N=35) or second- or later-line treatment (N=50). Nausea NRS decreased from 6.1±2.2 to 1.8±2.0 (differences: −4.3, 95% CI −3.7 to −4.9, p

Objective To evaluate the opioid-induced constipation burden in the subgroup of patients with lung cancer who participated in the observational Opioid-Induced Constipation in Patients with Cancer Pain in Japan (OIC-J) study. Methods The prospective, observational study, OIC-J, included 212 patients with various tumour types, 33% of whom had lung cancer. The incidence of opioid-induced constipation was evaluated using several diagnostic criteria, as well as the physician’s diagnosis and patient’s subjective assessment. Following initiation of opioids, patients recorded details of bowel movements (i.e. date/time, Bristol Stool Scale form, sensations of incomplete evacuation or anorectal obstruction/blockage and degree of straining) in a diary for 2 weeks. Relationships between patient characteristics and opioid-induced constipation onset and effects of opioid-induced constipation on quality of life were explored. Results In total, 69 patients were included in this post hoc analysis. The incidence of opioid-induced constipation varied (39.1–59.1%) depending on which diagnostic criteria was used. Diagnostic criteria that included a quality component or a patient’s feeling of bowel movement as an evaluation item (i.e. Rome IV, physician’s diagnosis, Bowel Function Index, patient’s assessment) showed higher incidences of opioid-induced constipation than recording the number of spontaneous bowel movements alone. Opioid-induced constipation occurred rapidly after initiating opioids and had a significant impact on Patient Assessment of Constipation Symptoms total score (P = 0.0031). Patient baseline characteristics did not appear to be predictive of opioid-induced constipation onset. Conclusions In patients with lung cancer, opioid-induced constipation can occur quickly after initiating opioids and can negatively impact quality of life. Early management of opioid-induced constipation, with a focus on quality-of-life improvement and patient’s assessments of bowel movements, is important for these patients., In lung cancer patients, opioid-induced constipation can occur quickly after initiating opioids and can negatively impact quality of life. Treatment with a focus on quality of life and patient’s assessments of bowel movements is important.

Background Constipation is a common side effect of opioid therapy. An observational study of opioid-induced constipation (OIC) in Japanese patients with cancer (OIC-J) included 212 patients with various tumor types. This post hoc analysis of OIC-J evaluated a subgroup of patients with gastrointestinal (GI) cancer. Methods Patients were aged ≥ 20 years, starting strong opioid therapy, had an ECOG PS of ≤ 2, and must have had ≥ 3 bowel movements during the week before enrollment. OIC was evaluated for 2 weeks after opioid initiation using the Rome IV diagnostic criteria for colorectal disorders, as well as physician’s diagnosis, number of spontaneous bowel movements, Bowel Function Index score, and patient’s self-assessment. Relationships between baseline characteristics and OIC incidence, and the effects of OIC on quality of life (QOL) were also explored. Results Fifty patients from OIC-J who had GI cancer [colon (50%), stomach (28%), and esophageal (22%)] were included. OIC incidence varied by which diagnostic criteria were used (46.0–62.0%) and occurred rapidly after initiating opioid therapy. The use of prophylactic laxatives reduced the overall incidence rate of OIC from 71.0% to 47.4%. No baseline characteristics, except comorbidities, were associated with OIC incidence. Change from baseline to day 15 in PAC-SYM total score was significantly greater for patients with OIC versus those without OIC (0.188 versus −0.362; P = 0.0011). Conclusions This post hoc analysis suggests that OIC occurs rapidly in patients with GI cancer after initiating opioid therapy, and negatively impacts QOL. Early and effective intervention strategies may be particularly useful in this group. Additional Information Coauthor Makio Gamoh is deceased.

Opioid-induced constipation (OIC) can limit the clinical benefit of opioid treatment. This post-hoc analysis evaluated the association between the Rome IV diagnostic criteria and other measures for OIC, including the Bowel Function Index (BFI), correlation between demographics and OIC onset, impact of OIC on pain treatment, and impact of patient–healthcare professional (HCP) communication on patient satisfaction. Patients recorded bowel habits in paper diaries for 14 days following opioid initiation. Study-specific questionnaires were used to evaluate patient awareness of OIC and satisfaction. Patients were ≥20 years old, initiating strong opioid therapy for cancer pain, had an ECOG PS ≤ 2, and had no constipation (≥3 bowel movements within 7 days of enrollment). A total of 220 patients were enrolled. The sensitivity and specificity of BFI for identifying OIC were 81.2% and 54.7%, respectively. Age &lt, 65 versus ≥65 years (odds ratio (OR) = 0.510, 95% confidence interval (CI): 0.267–0.977) and the presence or absence of comorbidities (OR = 0.443, 95% CI: 0.221–0.885) were correlated with OIC onset. The proportion of inpatients with sustainable pain control at week 2 was similar in patients with or without OIC (60.0% vs. 67.2%, respectively). By patient assessment, there was a significant correlation between an adequate level of patient–HCP communication and satisfaction with OIC treatment (OR = 9.538 (95% CI: 1.577–57.681)). Using BFI to screen for OIC represents a valid approach in patients with cancer pain. Patient–HCP communication is essential for effective management of OIC in patients with cancer pain.

Psychological symptoms are common in patients with non-malignant respiratory disease (NMRD). Psychologists can likely play a role in NMRD palliative care. We aimed to explore the expectations of respiratory physicians from psychologists in NMRD palliative care.An ad hoc questionnaire was developed based on a free-descriptive questionnaire survey among respiratory physicians from four hospitals in Japan. Using this questionnaire, we surveyed respiratory physicians from eight hospitals in Japan and assessed their expectations of psychologists' support and outcomes. Expectations were compared between physicians with and without experience of working with psychologists.The quantitative questionnaire was completed by 129 physicians. Data analysis from 108 participants revealed that the highly expected support included "getting early information on patients' psychological distress" (97.2%) and "counseling family members regarding anxiety caused by changes in patient's condition" (96.3%). Physicians also expected "relief in patient's psychological distress" (96.3%) and "providing the psychological support that families need" (95.4%) from psychologists. Compared to physicians with experience of working with psychologists, those without expected more in terms of "giving specific advice on the way of communication and psychological support" (p = 0.035) and "providing psychological support for difficult-to-handle patients and families on behalf of other medical staff" (p = 0.036).Respiratory physicians may expect relief of psychological distress experienced by patients and their families from psychologists by getting information about their distress and providing psychological support. These results may be useful for psychologists to provide palliative care for patients with NMRD in collaboration with respiratory physicians.

Duloxetine has some effect against cancer neuropathic pain (CNP); however, predictors of duloxetine response are unclear. This study sought to identify predictors of duloxetine response in patients with CNP. Patients (N = 70) with CNP unresponsive to or intolerant of opioid–pregabalin combination therapy, with a brief pain inventory-short form (BPI-SF) Item 5 score (average pain) ≥ 4, and with a total hospital anxiety and depression scale score < 20, were randomized to a duloxetine or a placebo group. Multiple linear regression analysis was conducted to identify predictors of duloxetine response as a secondary analysis with the change in the average pain score on day 10 from day 0 as the dependent variable, and the following five covariates; baseline (day 0) average pain score, baseline opioid dose, continuation/discontinuation of pregabalin, and items 20 and 21 score of the short-form McGill pain questionnaire 2 (SF-MPQ-2) as independent variables. Of the four domains (continuous pain, intermittent pain, neuropathic pain, and affective descriptors) score of SF-MPQ-2 on day 0, significant differences were observed in the neuropathic pain domain (p = 0.040) in change on the average pain between day 10 and day 0 in the duloxetine group. Multiple linear regression analysis revealed that patients with a high score for SF-MPQ-2 Item 21 (tingling pain) on day 0 had a significantly greater change in average pain between day 10 and day 0 (p = 0.046). Patients with a high score for SF-MPQ-2 Item 21 might benefit more from duloxetine.

ObjectivesDyspnoea is a common and distressing symptom in patients with cancer. We aimed to analyse the association between dyspnoea and related factors and to estimate their causal relationship.MethodsA cross-sectional study was conducted. Patients with cancer with dyspnoea and a mean Numerical Rating Scale (NRS) of ≥3 over 24 hours were enrolled at 10 institutions in Japan from December 2019 to February 2021. The outcomes included dyspnoea, cough and pain NRS over 24 hours, Eastern Cooperative Oncology Group Performance Status, Hospital Anxiety and Depression Scale, Somatosensory Amplification Scale, opioids for dyspnoea and respiratory failure. Path analyses were conducted to estimate the direct and indirect paths with reference to dyspnoea and related factors.ResultsA total of 209 patients were enrolled and 208 patients were included in the analysis. Cough worsened dyspnoea (β=0.136), dyspnoea increased emotional distress (β=1.104), emotional distress increased somatosensory amplification (β=0.249) and somatosensory amplification worsened cough (β=0.053) according to path analysis.ConclusionThere may be a vicious circle among dyspnoea and related factors: cough worsened dyspnoea, dyspnoea increased emotional distress, emotional distress increased somatosensory amplification and somatosensory amplification worsened cough. When treating dyspnoea in patients with cancer, managing these factors aimed at interrupting this vicious circle may be useful.Trial registration numberUMIN Clinical Trials Registry (UMIN000038820).

Background: Dyspnea is common in interstitial lung disease (ILD) patients and often refractory to conventional treatment. Little is known regarding the safety of systemic morphine in ILD p...

Objective Myofascial pain syndrome (MPS) is caused by overload or disuse of skeletal muscles. Patients with cancer are often forced to restrict their movement or posture for several reasons. The study was conducted to investigate the prevalence and risks of MPS in patients with incurable cancer. The efficacy of trigger point injection (TPI) was also explored. Methods This was a multicenter, prospective observational study. Patients with incurable cancer who started receiving specialist palliative care were enrolled. We investigated the MPS in this population and accompanying risk factors for restricting body movement. Pre- and post-TPI pain was also evaluated using a Numerical Rating Scale (NRS) in patients who received TPI. The primary outcome was the prevalence of MPS. Results A total of 101 patients were enrolled from five institutions in Japan. Most of the patients (n = 94, 93.1%) had distant metastases, and half of the patients (50, 49.5%) received anticancer treatment. Thirty-nine (38.6%) patients had MPS lesions at 83 sites. Multivariate analysis revealed that the significant risk factor for MPS was poor Performance Status (PS) (odds ratio 3.26; 95% confidence interval [CI] 1.18–9.02, P = .023). We performed TPI for 40 out of 83 MPS lesions. Mean NRS for MPS before TPI was 7.95, which improved to 4.30 after TPI (P Conclusions MPS was common in patients with incurable cancer and the risk factor identified in this study was poor performance status. TPI could be a treatment option.

To examine the safety, effectiveness, and patient-perceived benefit of treatment with olanzapine for nausea and vomiting (N/V) in patients with advanced cancer.We conducted a multicenter prospective observational study in a tertiary care setting (Trial registration number: UMIN000020493, date of registration: 2016/1/12). We measured the following: average nausea in the last 24 h using a Numeric Rating Scale (NRS: range 0-10) at baseline and day 2, patient-perceived treatment benefit (based on a 5-point verbal scale), and adverse events (AEs; using the Common Terminology Criteria for Adverse Events version 4).The 85 participants (45% men) had a mean age of 58.7±15.8 years. Major causes of N/V were opioids (44%) and chemotherapy (34%). All patients received a daily dose of olanzapine of 5 mg or less as first-line treatment (N=35) or second- or later-line treatment (N=50). Nausea NRS decreased from 6.1±2.2 to 1.8±2.0 (differences: -4.3, 95% CI -3.7 to -4.9, p0.001). The proportion of patients who did not experience vomiting episodes in the last 24 h increased from 40-89%. Mean decrease in nausea NRS by patient-perceived treatment benefit were as follows: -0.8 for "none" (n=4, 5%); -2.8 for "slight" (n=17, 20%); -3.3 for "moderate" (n=14, 16%); -4.7 for "lots" (n=25, 29%); and -6.1 for "complete" (n=25, 29%; p-for-trend0.001). The most prevalent AE was somnolence (n=15, 18%).Short-term and relatively low-dose olanzapine treatment was effective for multifactorial N/V. Confirmatory studies with longer observation periods are needed to clarify the duration of the effect and adverse events.

Background: Neuroleptics are commonly used in palliative care settings. However, adverse events of neuroleptics, known as extrapyramidal symptoms (EPSs), might be overlooked in clinical practice. We conducted this study to explore the prevalence of EPSs in palliative care setting. Methods: This multicenter, prospective, observational study included patients who 1) were referred to either a specialist palliative care team or a palliative care unit, 2) had a diagnosis of cancer, and 3) were ≥20 years of age. We investigated the prevalence of EPSs and medications used. The primary outcome was the overall Drug-Induced Extrapyramidal Symptom Scale (DIEPSS) score. Results: Between November 2015 and October 2016, 149 patients from 5 centers in Japan were enrolled. The median age was 67 years (range: 21–88 years) and the study population included 81 men (54.4%). The cancer types included lung (55 patients, 36.9%), upper gastrointestinal tract (5, 3.3%), hepatobiliary (19, 12.8%); breast (12, 8.1%); head and neck (10, 6.7%), gynecologic (10, 6.7%), genitourinary (10, 6.7%), and others (28, 18.8%). The median Karnofsky performance status was 60 (20–100). Most patients (86.6%) did not experience delirium. Thirty-nine (26.2%) patients received one or more EPS-inducing medications. EPSs occurred in 4 (2.7%) patients with a cutoff score of 5 points for 5 parkinsonism items in DIEPSS. Conclusion: A lower frequency (Trial registration: This study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) (UMIN000019810) on 16, November, 2015.

ObjectivesOpioids are often administered for cancer-related pain relief. However, few reports have evaluated the association between opioids and immune checkpoint inhibitor treatment for patients with non-small-cell lung cancer (NSCLC). The aim of this retrospective study was to reveal the effect of opioids on the prognosis of patients harbouring NSCLC treated with nivolumab.MethodsThe medical records of consecutive patients with NSCLC receiving nivolumab at our institution were retrospectively reviewed. We collected clinical data at the time of nivolumab treatment initiation. Propensity score matching (PSM) was performed to minimise potential selection bias. We compared clinical outcomes with and without baseline opioid use.ResultsOf the 296 patients identified in the study, after PSM, 38 cases with opioid use and matched 38 cases without opioid use were selected. The overall response rate was significantly lower in patients with opioid use than in those without (2.63%, 95% CI 0.47% to 13.49%, vs 21.05%, 95% CI 11.07% to 36.35%; p=0.0284). The median progression-free survival in patients with opioid use was significantly shorter than that in patients without (1.17, 95% CI 0.93 to 1.73 months, vs 2.07 95% CI 1.23 to 4.73 months; p=0.002). The median overall survival in patients with opioid use was significantly shorter than that in patients without (4.20, 95% CI 2.53 to 6.20 months, vs 9.57, 95% CI 2.23 to not reached months; p=0.018).ConclusionsPatients with NSCLC receiving regular opioid administration at nivolumab treatment initiation had a worse nivolumab treatment outcome than patients without opioid use.

Dyspnea is highly prevalent in patients with idiopathic interstitial pneumonias (IIPs).The objective of this study is to examine the effectiveness and safety of continuous subcutaneous morphine for dyspnea in terminally ill IIP patients.We retrospectively reviewed cases of terminally ill IIP patients who received continuous subcutaneous morphine for dyspnea.We reviewed dyspnea severity measured using numerical rating scale (NRS) and respiratory rate (RR) before and two and four hours after morphine initiation. We conducted subgroup analyses of patients with and without noninvasive positive pressure ventilation (NPPV).Twenty-five patients were included in this study. Median morphine dose at morphine initiation and two and four hours after treatment was 0.25, 0.25, and 0.5 mg/hour, respectively. Dyspnea NRS decreased significantly four hours after (mean ± standard deviation: 5.32 ± 2.58, p = 0.04) but not two hours (5.52 ± 2.43, p = 0.11) after morphine initiation compared with baseline (7.08 ± 2.33). RR did not change significantly either two or four hours after treatment compared with baseline. The median survival after morphine initiation was 47 hours. Patients who were not using NPPV showed significantly improved dyspnea both two and four hours after treatment compared with baseline, although patients who used NPPV showed no significant improvement with morphine. RR did not significantly change in either subgroup.Morphine might improve dyspnea in terminally ill IIP patients without decrease in RR.

© 2019, Springer-Verlag GmbH Germany, part of Springer Nature. Purpose: Duloxetine has some effect against cancer neuropathic pain (CNP); however, predictors of duloxetine response are unclear. This study sought to identify predictors of duloxetine response in patients with CNP. Methods: Patients (N = 70) with CNP unresponsive to or intolerant of opioid–pregabalin combination therapy, with a brief pain inventory-short form (BPI-SF) Item 5 score (average pain) ≥ 4, and with a total hospital anxiety and depression scale score < 20, were randomized to a duloxetine or a placebo group. Multiple linear regression analysis was conducted to identify predictors of duloxetine response as a secondary analysis with the change in the average pain score on day 10 from day 0 as the dependent variable, and the following five covariates; baseline (day 0) average pain score, baseline opioid dose, continuation/discontinuation of pregabalin, and items 20 and 21 score of the short-form McGill pain questionnaire 2 (SF-MPQ-2) as independent variables. Results: Of the four domains (continuous pain, intermittent pain, neuropathic pain, and affective descriptors) score of SF-MPQ-2 on day 0, significant differences were observed in the neuropathic pain domain (p = 0.040) in change on the average pain between day 10 and day 0 in the duloxetine group. Multiple linear regression analysis revealed that patients with a high score for SF-MPQ-2 Item 21 (tingling pain) on day 0 had a significantly greater change in average pain between day 10 and day 0 (p = 0.046). Conclusion: Patients with a high score for SF-MPQ-2 Item 21 might benefit more from duloxetine.

Context Although opioids and pregabalin are widely used for cancer-related neuropathic pain (CNP), no clinical trials exist to determine which medications are effective when an opioid-pregabalin combination therapy fails. Objectives We investigated the efficacy of duloxetine for CNP nonresponsive or intolerant to opioid-pregabalin combination therapy. Methods A multicenter, randomized, double-blind, placebo-controlled trial was performed at 12 specialized palliative care services in Japan. Patients with CNP average pain scores (Brief Pain Inventory [BPI]–Item 5) ≥ 4 in the previous 24 hours and nonresponsive or intolerant to opioid-pregabalin combination therapy were eligible. Patients with chemotherapy-induced peripheral neuropathies were excluded. Patients were administered duloxetine 20 mg/day titrated to 40 mg/day or placebo for 10 days. The primary endpoint was BPI-Item 5 on Day 10. Responder analysis measured proportions of patients with 30% and 50% pain decreases. Results Seventy patients were enrolled. Complete case analysis revealed mean BPI-Item 5 on Day 10 of 4.03 for Group D vs. 4.88 for Group P (P = 0.053). Baseline observation carried forward analysis revealed mean BPI-Item 5 on Day 10 of 4.06 and 4.91 for Groups D and P, respectively (P = 0.048). Clinically meaningful pain improvement (≥30%) was reported by 44.1% (n = 15) of patients in Group D vs. 18.2% (n = 6) in Group P (P = 0.02); 32.4% (n = 11) vs. 3.0% (n = 1) of patients in Groups D and P, respectively, reported pain reduction ≥ 50% (P = 0.002). Conclusion Adding duloxetine to opioid-pregabalin therapy might have clinical benefit in alleviating refractory CNP. Further studies are needed to conclude the efficacy of adding duloxetine.

This multicenter, prospective, observational cohort study assessed opioid induced constipation (OIC) in Japanese patients with cancer. Eligible patients had stable cancer and an ECOG PS of 0‐2. OIC incidence based on the Rome IV diagnostic criteria was determined by patient diary entries during the first 14 days of opioid therapy. The proportion of patients with OIC was calculated for each 1‐week period and the overall 2‐week study period. Secondary measurements of OIC included the Bowel Function Index (BFI) score (patient assessment administered by physician), spontaneous bowel movements (SBMs) per week (patient assessment), and physician assessments. Medication for constipation was allowed. Two hundred and twenty patients were enrolled. The mean morphine‐equivalent dose was 22 mg/day. By Rome IV criteria, the cumulative incidence of OIC was 56% (95% CI: 49.2%‐62.9%); week 1, 48% (95% CI: 40.8%‐54.6%); week 2, 37% (95% CI: 30.1%‐43.9%). The cumulative incidence of OIC was lower in patients who received prophylactic agents for constipation (48% [95% CI: 38.1%‐57.5%]) than in patients who did not (65% [95% CI: 55.0%‐74.2%]). The cumulative incidences of OIC were 59% (95% CI: 51.9%‐66.0%), 61% (95% CI: 54.3%‐68.1%), and 45% (95% CI: 38.0%‐51.8%) based on BFI scores, physician assessments, and SBM frequency, respectively. Frequency of BMs/week before starting opioids was the most influential factor for the occurrence of OIC. Utilization of prophylactic agents for constipation was associated with a modest effect on reducing the incidence of OIC. The incidences of OIC reported were variable depending on the diagnostic tool involved.

Context Many patients who have cancer consider opioid-induced constipation (OIC) to be a burdensome side effect of opioid treatment. Objectives To evaluate patient-reported outcomes in Japanese patients with cancer pain and OIC. Methods This prospective observational study evaluated OIC incidence for two weeks in patients with cancer after they initiated strong opioid therapy. Rome IV diagnostic criteria, a physician's diagnosis, spontaneous bowel movements, Bowel Function Index score, and patients' daily self-assessments were used. Changes from baseline in Patient Assessment of Constipation Symptoms and Patient Assessment of Constipation Quality of Life (PAC-QOL) scores were compared between patients with and without OIC. Patients and health care providers (HCPs) completed study-specific questionnaires regarding OIC burden, treatment satisfaction, and patient-provider communications. Results Among 212 enrolled patients, the incidence of OIC was 47.6% by patients' self-assessments, with a cumulative incidence of 30.2% by Day 3 and 43.5% by Day 7. Patient Assessment of Constipation Symptoms and PAC-QOL overall scores from patients with OIC worsened significantly from baseline compared with patients without OIC by all diagnostic criteria, except for spontaneous bowel movement frequency for PAC-QOL. Patients and HCPs were generally satisfied with OIC treatment; however, 53.5% of patients and approximately 40.0% of HCPs reported that OIC affected pain management. Most patients and HCPs reported that OIC conditions were sufficiently or essentially communicated. Conclusion After starting opioid therapy, patients recognized OIC onset and its impact on cancer pain management, highlighting the need for effective patient-provider communications, diagnosis, and treatment of OIC to improve QOL for patients with cancer receiving opioid analgesics.

To compare the efficacy of antipsychotics (APs) for delirium treatment in patients with cancer, 27 patients treated with 1 of the 4 APs, haloperidol (HPD), risperidone (RIS), olanzapine (OLZ), and quetiapine (QTP), were divided into 2 groups: long half-life (T1/2; HPD, RIS, and OLZ) versus short T1/2 (QTP) or the multiacting receptor-targeted APs (MARTAs; OLZ and QTP) versus the non-MARTA (HPD and RIS). The symptom severity was evaluated by the memorial delirium rating scale (MDAS) on days 0, 3, and 7 following intervention. Significant improvements in total MDAS scores were found in all groups on day 3. However, on day 7, only the short T1/2 group and MARTA group showed significant improvement. Consideration of an AP’s pharmacological properties may be helpful for improving the outcomes of pharmacological delirium intervention in patients with cancer.

Objective:Little is known about the associations between family satisfaction with end-of-life care and caregiver burden. We conducted a researcher-assisted questionnaire survey to clarify the impact of caregiver burden on family satisfaction and to determine the types of burden that decrease family satisfaction.Method:Bereaved family caregivers of patients with advanced cancer who received our outreach palliative care service were retrospectively identified. Family satisfaction with the end-of-life care provided by the palliative care service and caregiver burden were quantified using the Japanese versions of the FAMCARE Scale and the Zarit Burden Interview (ZBI), respectively.Results:Our study subjects included 23 family caregivers. The mean scores on the FAMCARE Scale and the ZBI for the total population were 72.8 ± 11.2 and 22.8 ± 17.3, respectively, indicating moderate-to-high satisfaction and low-to-moderate burden. Caregiver burden had a strong negative correlation to family satisfaction with end-of-life care (Spearman's rho [ρ] = −0.560, p = 0.005), which remained after adjustment for potential confounders (standardized beta [β] = −0.563, p = 0.01). Several burden items—including loss of control, personal time, social engagement with others, feeling angry with the patient, feeling that the patient wants more help than he/she needs, and a wish to leave the care to someone else—were associated with decreased satisfaction. The major cause of dissatisfaction for family members included the information provided regarding prognosis, family conferences with medical professionals, and the method of involvement of family members in care decisions.Significance of results:Caregiver burden can be a barrier to family satisfaction with end-of-life care at home. A home care model focused on caregiver burden could improve end-of-life experiences for patients and family caregivers.

Background: Smoking cessation is often followed by weight gain, which may attenuate motivation to sustain a quit attempt. Objectives: The aim was to identify factors associated with weight gain in smokers who received smoking cessation therapy (SCT) in Japan. Methods: The weight change in 283 smokers between baseline and 12 months after finishing SCT was observed. Factors associated with marked weight gain of 3.5 kg or more were identified using stepwise logistic regression. Results: Smoking cessation success was 83% (234/283) at the completion of SCT but decreased to 69% (194/283) 12 months later. Twelve months after the end of SCT, age 50 and over (OR = 0.38, 95% CI [0.19, 0.76]) and varenicline use (OR = 0.30, 95% CI [0.11, 0.78]) were protected against marked weight gain, whereas presence of a comorbidity (OR = 3.33, 95% CI [1.10, 10.00]), high level of nicotine dependence at baseline (OR = 2.07, 95% CI [1.09, 3.92]), and successfully quitting smoking (OR = 4.57, 95% CI [1.94, 10.08]) were associated with marked weight gain. Discussion: Understanding the factors associated with weight gain after smoking cessation can help in the design of nursing interventions to lessen or prevent weight gain among smokers who try to quit.

Intramedullary spinal cord metastasis of non-small cell lung cancer is rare, and it has a short prognosis. We report a 53-year-old man diagnosed with cT4N0M0, stage IIIA squamous cell lung cancer. Ten months after left pneumonectomy (pT4N0M0), an intramedullary spinal cord tumor developed at the axis level. The intramedullary spinal cord tumor was resected, and he was diagnosed with metastatic squamous cell lung cancer. Radiotherapies and another tumor resection were conducted, as he had a good performance status and the discrete lesion was associated with the risk of brain stem compression. Multimodal local treatments for intramedullary spinal cord metastasis caused the tumor to shrink, and he lived for 25 months after the spinal metastasis occurred.

Context. Hospital-based palliative care consultation teams (PCCTs) are rapidly being disseminated throughout Japan. The roles of PCCTs have changed during the past decade, particularly with the introduction of a modified national cancer care act to promote early palliative care and integrated oncology and palliative care. Objectives This study aimed to develop a consultation team standard for hospital-based palliative care in Japan. Methods We developed a provisional standard based on literature review and used a modified questionnaire-based Delphi method. Our Delphi panel comprises 20 experts selected from all relevant disciplines. Results All experts selected responded to the surveys over all rounds, and 14 of the 20 participated in the panel meeting. In the first round, 79 of 109 statements were judged to be appropriate, and 30 of 109 statements led to disagreements. About 16 of those 30 statements underwent minor revision, 1 was divided into two statements, and 13 remained unchanged. We then added six statements based on a discussion among participants and authors. In addition, based on comments from an external reviewer, we revised the standard, resulting in four statements being combined into two for a new total of 114 statements. In the second round, 108 of 114 statements were judged to be appropriate, and in the third round, none of the six controversial statements were judged to be appropriate. The final version comprises 108 statements. Conclusion We developed a standard for PCCTs in Japanese cancer hospitals. This standard provides a useful guide for clinical activities and a tool to evaluate quality of palliative care.

10102Background: Management of cancer patients experiencing neuropathic pain (NP) refractory to opioids remains an important challenge. Gabapentinoids are one of the most widely used therapies for ...

The purpose of this study was to examine the feasibility of a physical activity intervention program and the relationship between physical activity and psychological adjustment in Japanese advanced lung cancer patients in chemotherapy. The study was designed as an intervention study and the sample was comprised of advanced lung cancer patients in chemotherapy, all of whom provided written informed consent. Physical activity was recorded by uniaxial accelerometry monitors (Lifecoder®, Suzuken, Co., Ltd), and psychological adjustment was measured by the Hospital Anxiety and Depression Scale (HADS). Each participant received 1) feedback about the data of their footsteps, 2) positive reinforcement for being physically active, 3) enhancement of autonomy for being physically active and 4) information about setting goals related to physical activity in the first, second, and fourth week. Drop out rate of participants was 33.3% (3/9). None of the variables changed over the four weeks of the study. Spearman's correlational analysis revealed that higher steps were correlated with lower depression (r= −.90, p

This study examined the application of the trans-theoretical model (TTM) for readiness for decision-making of outpatient chemotherapy of Japanese advanced lung cancer patients by a cross sectional questionnaire survey. A questionnaire was conducted with 105 Japanese patients diagnosed with advanced lung cancer receiving chemotherapy. We classified them according to the TTM stages, including 4 in precontemplation, 42 in contemplation, 22 in preparation, and 35 in action. The valid model (chi(2) (37) = 42.56, p = 0.24; GFI = 0.93; AGFI = 0.88; CFI = 0.98; RMSEA = 0.04; AIC = 100.56) derived from structural equation modeling (SEM) revealed that stage of outpatient chemotherapy was significantly affected mostly by decisional-balance (beta = 0.60, p < 0.001) and partially by time from the patient's house to the hospital (beta = -0.15, p < 0.10), and that decisional-balance was significantly affected by self-efficacy (beta = 0.48, p < 0.001) and nausea (beta = -0.23, p < 0.01). The findings from our study provided encouraging results for adopting the TTM in decision making for outpatient chemotherapy in Japanese cancer care and several clinical implications were obtained from the results.

Significant others play an important role in providing support in patients' lives, but some types of support negatively affect the patients. This study was conducted in early-stage breast cancer patients to examine the structure of support, which was provided by their significant others and assessed negatively by the patients, and to identify negative support relating to the psychological adjustment of these patients. Thus, we first conducted interviews among 28 breast cancer patients to identify these support items assessed as negative; next, we conducted a questionnaire survey using the resulting items in 109 postoperative patients who had early-stage breast cancer. We performed exploratory and confirmatory factor analyses and obtained a valid second-order factor structure, including superordinate factors (excessive engagement, avoidance of problems and underestimation) and subordinate factors (overprotection, encouragement and management). Among these factors, the avoidance of problems was the only factor to be negatively associated with psychological adjustment of the patients, suggesting that these patients receive problem-avoiding support. The results of our study suggest that such problem-avoiding support from significant others can be counter-productive and potentially worsen the psychological adjustment of breast cancer patients.

Background A randomized trial of vinorelbine plus gemcitabine followed by docetaxel (VGD) versus paclitaxel plus carboplatin (PC) in patients with advanced non-small-cell lung cancer showed no difference in overall survival (median survival time: 13.6 versus 14.1 months) between the two treatment groups. We report here the results of quality-of-life (QOL) study initiated in the mid-course of this randomized trial. Methods The patients themselves assessed the Functional Assessment of Cancer Therapy (FACT)-Lung (FACT-L), FACT-Taxane and the Functional Assessment of Chronic Illness Therapy - Spirituality (FACIT-Sp) QOL instruments at baseline and 6, 12 and 18 weeks after the treatment. The primary endpoint was a comparison of total QOL score for each assessment instrument between the two groups. Results Sixty-eight patients from the trial (VGD, 34; PC, 34) who submitted baseline questionnaires and at least one questionnaire over the course of treatment were eligible. Longitudinal analysis showed a significant difference in slope of the FACT-Taxane score (p = 0.004) between treatment regimens over time, but no difference was found in FACT-L score (p = 0.311) and FACIT-Sp score (p = 0.466) between the two groups. Conclusions The significant difference in slope of FACT-Taxane score favored the VGD regimen. These data should be considered in treatment decision-making for patients with advanced non-small-cell lung cancer. Trial registration NCT00242983.

IntroductionCancer-related fatigue greatly influences quality of life in cancer patients; however, no specific treatments have been established for cancer-related fatigue, and at present, no medication has been approved in Japan. Systematic research using patient-reported outcome to examine symptoms, particularly fatigue, has not been conducted in palliative care settings in Japan. The objective was to evaluate fatigue, pain, and quality of life in cancer patients at the point of intervention by palliative care teams.Materials and methodsPatients who were referred to palliative care teams at three institutions and met the inclusion criteria were invited to complete the Brief Fatigue Inventory, Brief Pain Inventory, and European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative.ResultsOf 183 patients recruited, the majority (85.8%) were diagnosed with recurrence or metastasis. The largest group (42.6%) comprised lung cancer patients, of whom 67.2% had an Eastern Cooperative Oncology Group Performance Status of 0-1. The mean value for global health status/quality of life was 41.4, and the highest mean European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 15-Palliative symptom item score was for pain (51.0). The mean global fatigue score was 4.1, and 9.8%, 30.6%, 38.7%, and 20.8% of patients' fatigue severity was classified as none (score 0), mild (1-3), moderate (4-6), and severe (7-10), respectively.DiscussionCancer-related fatigue, considered to occur more frequently in cancer patients, was successfully assessed using patient-reported outcomes with the Brief Fatigue Inventory for the first time in Japan. Results suggested that fatigue is potentially as problematic as pain, which is the main reason for palliative care.

The soluble form of Fas (sFas) can block apoptosis induced by the Fas ligand in vitro. A recent report demonstrated that mice injected with sFas displayed autoimmune features. Therefore, an elevated serum concentration of sFas may be associated with lymphoproliferation and autoimmune diseases. We measured the serum concentrations of sFas in 77 patients with non-Hodgkin's lymphoma (NHL) [8 angioimmunoblastic T-cell lymphoma (AIL), 12 T-cell NHL, 53 B-cell NHL, and 4 natural killer-cell NHL]. Elevated concentrations of sFas were detected only in AIL, which is frequently accompanied by autoimmune diseases (P < 0.005 compared with age-matched controls). A possible association of sFas and autoimmune features in AIL is discussed. Am. J. Hematol. 58:334–336, 1998. © 1998 Wiley-Liss, Inc.

Adult T-cell leukemia-lymphoma (ATL) is resistant to currently available chemotherapy and has a poor prognosis. We describe here a patient with ATL successfully treated with 2-chlorodeoxyadenosine (2-CdA). A 75-year-old Japanese male with an acute type of ATL, who had become resistant to the initial cytotoxic chemotherapy, was treated with 2-CdA administered by continuous drip infusion of 0.09 mg/kg/d for seven consecutive days in one month (one cycle). After three cycles of treatment, partial remission (PR) was achieved. Surprisingly, 249 days after the administration of 2-CdA, ATL cells completely disappeared from the peripheral blood. PR was maintained during 10 weeks until evidence of a new lymphadenopathy. No remarkable toxicity of 2-CdA occurred.

18043 Background: JMTO LC00–03, a randomized trial of VGD versus PC in patients with advanced NSCLC, showed differences between the two treatment groups in response rate (25 vs 37.1%) and regimens’ specific toxicities including taxane-related toxicities such as numbness (0 vs 16.2%) and neuropathy (0.5 vs 9.6%), but not in overall survival (MST, 13.6 vs 14.1 mos) and progression-free survival (MST, 5.5 vs 5.8 mos). (Kawahara et al, # 7013, ASCO, 2006). Methods: Patients with advanced NSCLC were randomly assigned to VGD or PC. The patients were assessed with Functional Assessment of Cancer Therapy- FACT-L and FACT-Taxane score in baseline, and at 6-, 12-, 18-weeks after the treatment. The longitudinal analysis was used to compare mean changes of the QOL score over the two treatment groups. Results: Sixty-eight patients from the trial (VGD: 34, PC: 34) who submitted both baseline questionnaire and at least one questionnaire over the course of the treatment were subjects of the study. The table presents the estimated changes in mean scores in treatment arms over the time period. The longitudinal analysis showed significant difference in FACT-Taxane (p [Table: see text] [Table: see text]