Associations of nutrition impact symptoms with dietary intake and eating-related distress in patients with advanced cancer.

BACKGROUND & AIMS: There is no definition of nutrition impact symptoms (NISs) in cancer care. Moreover, there is a lack of evidence on the associations of NISs with dietary intake and eating-related distress (ERD) in advanced cancer. Therefore, this study aimed to determine the associations of NISs with dietary intake and ERD in patients with advanced cancer. METHODS: This study entailed a secondary analysis of a multicenter self-reported questionnaire designed to develop measurements that assess ERD experienced by patients. Participants evaluated their dietary intake and 19 symptoms regarded as NISs using a 10-point scale. To determine the association between dietary intake and the number of NISs with a score ≥4, estimated adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for the logistic regression model were calculated. Furthermore, to assess the association between ERD and the number of NISs with a score ≥4, multiple regression analysis was performed. RESULTS: A total of 302 patients were included in the analysis. The higher the number of NISs with a score ≥4, the lower the dietary intake tended to be. In the logistic regression model, significantly higher adjusted ORs than in the no NISs with a score ≥4 group were observed in the 4-6 NISs group, 7-9 NISs group, and 10 or more group (0.19 [95% CI, 0.07-0.52], p = 0.001; 0.11 [95% CI, 0.03-0.42], p = 0.001; 0.07 [95% CI, 0.01-0.36], p = 0.002, respectively). In the multiple regression analysis, the number of NISs with a score ≥4 was identified as one of the factors significantly associated with ERD. CONCLUSIONS: Having 4 or more NISs with a score ≥4 was shown to be predictive of the likelihood of reduced dietary intake. Furthermore, the higher the number of NISs with a score ≥4, the more likely the eating-related quality of life was impaired in advanced cancer.

Cancer Pain Management in Patients Receiving Inpatient Specialized Palliative Care Services.

CONTEXT: Cancer pain is a common complication that is frequently undertreated in patients with cancer. OBJECTIVES: This study is aimed at assessing the time needed to achieve cancer pain management goals through specialized palliative care (SPC). METHODS: This was a multicenter, prospective, longitudinal study of inpatients with cancer pain who received SPC. Patients were continuously followed up until they considered cancer pain management successful, and we estimated this duration using the Kaplan-Meier method. We investigated the effectiveness of pain management using multiple patient-reported outcomes (PROs) and quantitative measures, including pain intensity change in the Brief Pain Inventory. A paired-sample t-test was used to compare the pain intensity at the beginning and end of the observation period. RESULTS: Cancer pain management based on the PROs was achieved in 87.9% (385/438) of all cases. In 94.5% (364/385) of these cases, cancer pain management was achieved within 1 week, and the median time to pain management was 3 days (95% confidence interval [CI], 2-3). The mean worst pain intensity in the last 24 h at the start and end of observation were 6.9 ± 2.2 and 4.0 ± 2.3, respectively, with a difference of -2.9 (95% CI, -3.2 to -2.6; p < 0.01). Overall, 81.6% of the patients reported satisfaction with cancer pain management, and 62 adverse events occurred. CONCLUSION: SPC achieved cancer pain management over a short period with a high level of patient satisfaction resulting in significant pain reduction and few documented adverse events.

Prevalence of opioid-induced adverse events across opioids commonly used for analgesic treatment in Japan: a multicenter prospective longitudinal study.

PURPOSE: Although opioids have been shown to be effective for cancer pain, opioid-induced adverse events (AEs) are common. To date, little is known about the differences in risks of AEs by opioid type. This study was performed to compare the prevalence of AEs across opioids commonly used for analgesic treatment in Japan. METHODS: This study was conducted as a preplanned secondary analysis of a multicenter prospective longitudinal study of inpatients with cancer pain who received specialized palliative care for cancer pain relief. We assessed daily AEs until termination of follow-up. We rated the severity of AEs based on the Common Terminology Criteria for Adverse Events version 5.0. We computed adjusted odds ratios for each AE (constipation, nausea and vomiting, delirium, and drowsiness) with the following variables: opioid, age, sex, renal dysfunction, and primary cancer site. RESULTS: In total, 465 patients were analyzed. Based on the descriptive analysis, the top four most commonly used opioids were included in the analysis: oxycodone, hydromorphone, fentanyl, and tramadol. With respect to the prevalence of AEs among all analyzed patients, delirium (n = 25, 6.3%) was the most frequent, followed by drowsiness (n = 21, 5.3%), nausea and vomiting (n = 19, 4.8%), and constipation (n = 28, 4.6%). The multivariate logistic analysis showed that no single opioid was identified as a statistically significant independent predictor of any AE. CONCLUSION: There was no significant difference in the prevalence of AEs among oxycodone, fentanyl, hydromorphone, and tramadol, which are commonly used for analgesic treatment in Japan.

The effect of palliative care team intervention and symptom improvement using patient-reported outcomes: a multicenter prospective observational study.

PURPOSE: Hospital-based palliative care teams (HPCTs) are widespread internationally, but multicenter studies about their effectiveness, using patient-reported outcomes (PROs), are limited to Australia and a few other countries. We conducted a multicenter, prospective observational study in Japan to explore the effectiveness of the HPCTs using PROs. METHODS: Nationwide, eight hospitals participated in the study. We included newly referred patients for one month in 2021 and followed them for one month. We asked the patients to complete the Integrated Palliative Care Outcome Scale or the Edmonton Symptom Assessment System as PROs at the time of the intervention, three days later, and weekly after the intervention. RESULTS: A total of 318 participants were enrolled, of whom 86% were patients with cancer, 56% were undergoing cancer treatment, and 20% received the Best Supportive Care. After one week, the following 12 symptoms showed more than a 60% improvement from severe to moderate or less: vomiting (100%), shortness of breath (86%), nausea (83%), practical problems (80%), drowsiness (76%), pain (72%), poor sharing of feelings with family or friends (72%), weakness (71%), constipation (69%), not feeling at peace (64%), lack of information (63%), and sore or dry mouth (61%). Symptoms with improvement from severe/moderate to mild or less were vomiting (71%) and practical problems (68%). CONCLUSION: This multicenter study showed that HPCTs effectively improved symptoms in several severe conditions, as assessed by PROs. This study also demonstrated the difficulty of relieving symptoms in patients in palliative care and the need for improved care.

Difficulty swallowing and food bolus obstruction in advanced cancer: association with the cachexia-related quality of life.

BACKGROUND: Swallowing disorders including difficulty swallowing and food bolus obstruction, result in reduced dietary intake-a common occurrence that leads to cachexia in patients with advanced cancer. This study examined the effects of swallowing difficulty and food bolus obstruction on cachexia-related quality of life (QOL). METHODS: This study secondarily analyzed data from a self-reported questionnaire survey of adult patients with advanced cancer at 11 palliative care services. Difficulty swallowing and food bolus obstruction were measured using the 11-point Numeric Rating Scale (NRS), whereas dietary intake and cachexia-related QOL were assessed using the Ingesta-Verbal/Visual Analog Scale and the Functional Assessment of Anorexia/Cachexia Therapy Anorexia/Cachexia Subscale. A multiple logistic regression model was employed to determine the factors associated with varying degrees of difficulty swallowing and food bolus obstruction. RESULTS: Of the invited 495 patients, 378 agreed to participate (response rate 76.4%). After excluding participants with missing data, the data of 332 participants were analyzed; 26.5% had difficulty swallowing (NRS ≥1) and 28.3% had food bolus obstruction (NRS ≥1). Multivariate analysis revealed a substantial association between difficulty swallowing and food bolus obstruction and a decrease in cachexia-related QOL, regardless of performance status and the existence of cachexia. The coefficients for difficulty swallowing and food bolus obstruction were -6.34 [95% confidence interval (CI): -9.55 to -3.14, P<0.001] and -5.88 (95% CI: -8.68 to -3.09, P<0.001), respectively. CONCLUSIONS: Cachexia-related QOL deteriorated as difficulty swallowing and food bolus obstruction worsened; thus, healthcare providers must diagnose and treat swallowing disorders in a timely manner to prevent progression of cachexia and improve cachexia-related QOL.

Impact of taste/smell disturbances on dietary intakes and cachexia-related quality of life in patients with advanced cancer.

PURPOSE: Taste and smell are used to enjoy meals; however, impairments of these sensory perceptions seriously impact health and eating habits. This study is aimed at investigating the impact of taste and smell disturbances on dietary intakes and cachexia-related quality of life (QOL) in patients with advanced cancer. METHODS: Using a self-report questionnaire, we surveyed patients with advanced cancer undergoing treatment at 11 palliative care centers. Multivariate analyses were conducted to explore the impact of taste and smell disturbances on dietary intakes and cachexia-related QOL. Dietary intakes were assessed using the Ingesta-Verbal/Visual Analog Scale, while taste and smell disturbances were assessed using an 11-point Numeric Rating Scale (NRS). Cachexia-related QOL was assessed using the Functional Assessment of Anorexia/Cachexia Therapy Anorexia Cachexia Subscale (FAACT ACS). RESULTS: Overall, 378 patients provided consent to participate. After excluding patients with missing data, data were analyzed for 343 patients. Among them, 35.6% (n = 122; 95% [confidence interval (CI)] 0.28-0.38) and 20.9% (n = 72; 95% CI 0.17-0.25) experienced disturbances in taste (NRS ≥ 1) and smell (NRS ≥ 1), respectively. Multivariate analyses revealed that, independent of performance status and cancer cachexia, taste and smell disturbances were significantly associated with worse dietary intakes and deteriorating FAACT ACS scores. CONCLUSION: More severe taste and smell disturbances were associated with poorer dietary intakes and cachexia-related QOL. Diagnosing and treating such disturbances may improve dietary intakes and cachexia-related QOL, regardless of performance status and cachexia.

Development and validation of questionnaires for eating-related distress among advanced cancer patients and families.

BACKGROUND: Eating-related distress (ERD) is one type of psychosocial distress among advanced cancer patients and family caregivers. Its alleviation is a key issue in palliative care; however, there is no validated tool for measuring ERD. METHODS: The purpose of this study was to validate tools for evaluating ERD among patients and family caregivers. The study consisted of a development and validation/retest phase. In the development phase, we made preliminary questionnaires for patients and family caregivers. After face validity and content validity, we performed an exploratory factor analysis and discussed the final adoption of items. In the validation/retest phase, we examined factor validity with an exploratory factor analysis. We calculated Pearson's correlation coefficients between the questionnaire for patients, the Functional Assessment of Anorexia/Cachexia Therapy Anorexia Cachexia Subscale (FAACT ACS) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Cachexia 24 (EORTC QLQ-CAX24) and Pearson's correlation coefficients between the questionnaire for family caregivers and the Caregiver Quality of Life Index-Cancer (CQOLC) for concurrent validity. We calculated Cronbach's alpha coefficients (Cronbach's alpha) and intraclass correlation coefficients (ICCs) for internal consistency and test-retest reliability. We performed the Mann-Whitney U test between the questionnaires and cancer cachexia based on criteria from the international consensus for known-group validity. RESULTS: In the development phase, 162 pairs of patients and family caregivers were asked to participate, and 144 patients and 106 family caregivers responded. In the validation/retest phase, 333 pairs of patients and family caregivers were asked to participate, and 234 patients and 152 family caregivers responded. Overall, 183 patients and 112 family caregivers did the retest. Seven conceptual groups were extracted for the ERD among patients and family caregivers, respectively. Patient factors 1-7 correlated with FAACT ACS (r = -0.63, -0.43, -0.55, -0.40, -0.38, -0.54, -0.38, respectively) and EORTC QLQ-CAX24 (r = 0.58, 0.40, 0.60, 0.49, 0.38, 0.59, 0.42, respectively). Family factors 1-7 correlated with CQOLC (r = -0.34, -0.30, -0.37, -0.37, -0.46, -0.42, -0.40, respectively). The values of Cronbach's alpha and ICC of each factor and all factors of patients ranged from 0.84 to 0.96 and 0.67 to 0.83, respectively. Those of each factor and all factors of family caregivers ranged from 0.84 to 0.96 and 0.63 to 0.84, respectively. The cachexia group of patients had significantly higher scores than the non-cachexia group for each factor and all factors. CONCLUSIONS: Newly developed tools for measuring ERD experienced by advanced cancer patients and family caregivers have been validated.

Management of cancer pain due to bone metastasis.

Bone metastases frequently occur in patients with cancer. Skeletal-related events (SREs), including pain, impaired mobility, hypercalcemia, pathological fracture, spinal cord and nerve root compression, and bone marrow infiltration, can decrease the quality of life of the patients and increase the risk of morbidity. The mechanism of pain due to bone metastasis is complicated and involves various interactions among tumor cells, bone cells, activated inflammatory cells, and bone-innervating neurons. Cancer pain due to bone metastasis can be crippling and a chronic state that causes sarcopenia. For pain management, it is important to diagnose whether the pain is based on background pain or breakthrough pain due to bone metastasis. In addition, the management goal of cancer pain due to bone metastasis is not only to achieve pain relief but also to prevent pain progression and SREs. Pain mechanisms should be applied to achieve optimal management. This review aims to discuss the mechanisms of cancer pain due to bone metastasis and review the recommended drug therapies.

Difficulties Facing Junior Physicians and Solutions Toward Delivering End-of-Life Care for Patients with Cancer: A Nationwide Survey in Japan.

Background: Junior physicians' perceived difficulty in end-of-life care of patients with cancer has not been structurally investigated; therefore, current challenges and solutions in this area remain unknown. Objectives: To identify some difficulties junior physicians face in delivering end-of-life care for patients with cancer and to clarify the support required to reduce these difficulties. Design: A nationwide survey was conducted in over 300 institutions selected randomly from 1037 clinical training hospitals in Japan. Participants: From each of these institutions, two resident physicians of postgraduate year (PGY) 1 or 2, two clinical fellows of PGY 3-5, and an attending physician were requested to respond to the survey. Measurements: The survey investigated issues regarding end-of-life care using the palliative care difficulties scale with two additional domains ("discussion about end-of-life care" and "death pronouncement"). Items related to potential solutions for alleviating the difficulties as well were investigated. Results: A total of 198 resident physicians, 134 clinical fellows, and 96 attending physicians responded to the survey (response rate: 33.0%, 22.3%, and 32.0%). The results revealed that junior physicians face difficulties within specific domains of end-of-life care. The most challenging domain comprised communication and end-of-life discussion with patients and family members, symptom alleviation, and death pronouncement. The most favored supportive measure for alleviating these difficulties was mentorship, rather than educational opportunities or resources regarding end-of-life care. Conclusion: The findings of this study reveal the need for further effort to enrich the mentorship and support systems for junior physicians delivering end-of-life care.

Beliefs and Perceptions About Parenteral Nutrition and Hydration by Advanced Cancer Patients.

Background: The beliefs and perceptions of parenteral nutrition and hydration (PNH) by advanced cancer patients have not been elucidated. Objectives: To clarify their beliefs and perceptions and to explore the relationships between their beliefs and perceptions and cachexia stages. Design/setting/subjects: A questionnaire survey of advanced cancer patients receiving palliative care across Japan. Measurements: We asked patients to answer 15 items regarding their beliefs and perceptions of PNH. Frequencies were calculated for the patient characteristics and survey parameters. Comparisons were performed using the Mann-Whitney U test. We conducted a factor analysis and a multiple logistic regression analysis to identify the independent factors affecting cancer cachexia stages. Results: Among 495 patients, 378 responded. Due to missing data, 357 remained in the frequency distribution analysis, and 344 were classified into the noncachexia group (n = 174) and cachexia group (n = 170). Approximately 60% thought that PNH were beneficial. Approximately 70% considered PNH a standard medical practice. Approximately 70% did not feel that they received a sufficient explanation. There were no significant differences in any items between the two groups. We extracted four conceptual groups. The concept of "Belief that PNH are harmful" was identified as an independent factor [odds ratio 2.57 (95% confidence intervals 1.10-6.01), p = 0.030]. Conclusion: More than half of the patients thought that PNH were beneficial and standard medical practices with or without cancer cachexia. The negative perception of PNH decreased in patients with cancer cachexia.

Development of the opioid self-management scale for advanced Cancer patients with pain and examination of its validity and reliability.

BACKGROUND: Approximately 60% of outpatients with advanced cancer experience pain; therefore, self-management of opioid use is important for appropriate pain relief. To date, no studies have clearly described the concept of opioid self-management or assessed the factors involved, including the improvement of self-management abilities. This study developed, and evaluated the validity and reliability of an opioid self-management scale for advanced cancer patients with pain (OSSA). Opioid self-management in advanced cancer patients with pain was defined as the management of opioid medication performed by patients with advanced cancer to relieve cancer pain on their own. METHODS: Three phases were required for validation and reliability of the OSSA: 1) testing content validity, 2) testing face validity, and 3) testing construct validity, concurrent validity and reliability. RESULTS: After a three-phase process, the OSSA consisted of 33 items on six subscales. The structural equation modeling was such that the χ2 value was 709.8 (p < 0.001, df = 467), goodness-of-fit index was 0.78, adjusted goodness-of-fit index was 0.73, root mean squares of approximation was 0.063, and comparative fit index was 0.92. The Pearson correlation coefficients between the total OSSA score and the 24-hour average pain or pain relief over 24 hours were - 0.21 (p < 0.05) and 0.26 (p < 0.01), respectively. Cronbach's α was 0.93. The intraclass correlation coefficient range was 0.59-0.90. CONCLUSION: The findings of this study show that the OSSA has acceptable validity and reliability, and that better self-management leads to greater pain relief. The OSSA can be considered effective for use in research, but shortened version should be prepared for realistic and practical clinical use.

Development of a national health policy logic model to accelerate the integration of oncology and palliative care: a nationwide Delphi survey in Japan.

BACKGROUND: Despite recommendations to deliver palliative care to cancer patients and their caregivers, their distress has not been alleviated satisfactorily. National health policies play a pivotal role in achieving a comprehensive range of quality palliative care delivery for the public. However, there is no standardised logic model to appraise the efficacy of these policies. This study aimed to develop a logic model of a national health policy to deliver cancer palliative care and to reach consensus towards specific policy proposals. METHODS: A draft version of the logic model and specific policy proposals were formulated by the research team and the internal expert panel, and the independent external expert panel evaluated the policy proposals based on the Delphi survey to reach consensus. RESULTS: The logic model was divided into three major conceptual categories: 'care-delivery at cancer hospitals', 'community care coordination', and 'social awareness of palliative care'. There were 18 and 45 major and minor policy proposals, which were categorised into four groups: requirement of government-designated cancer hospitals; financial support; Basic Plan to Promote Cancer Control Programs; and others. These policy proposals were independently evaluated by 64 external experts and the first to third Delphi round response rates were 96.9-98.4%. Finally, 47 policy proposals reached consensus. The priority of each proposal was evaluated within the four policy groups. CONCLUSIONS: A national health policy logic model was developed to accelerate the provision of cancer palliative care. Further research is warranted to verify the study design to investigate the efficacy of the logic model.

Physicians' Beliefs and Attitudes Toward Hypoactive Delirium in The Last Days of Life.

CONTEXT: The perspective toward hypoactive delirium in the last days of life could be different among physicians. OBJECTIVES: To clarify the attitudes, beliefs, and opinions of palliative care physicians and liaison psychiatrists toward hypoactive delirium in the last days of life and to explore the association among these factors. METHODS: A nationwide cross-sectional questionnaire survey was conducted among 1667 physicians who were either certified palliative care specialists or liaison psychiatrists. Physicians' agreement with the appropriateness of pharmacological management (e.g., antipsychotics) (one item), their beliefs (11 items), and their opinions (four items) were measured. RESULTS: 787 (47%) physicians responded. 481 (62%) agreed to use of medications for hypoactive delirium in the last days of life, whereas 296 (38.1%) disagreed. More than 95% agreed with "hypoactive delirium at the end of life can be considered as a part of natural dying process." Multivariate analysis identified two belief subscales of "hypoactive delirium at the end of life is a natural dying process" and "antipsychotics are futile and harmful in managing hypoactive delirium" had a significant negative correlation with the use of medications. On the other hand, one belief subscale of "hypoactive delirium can be distressing even if patients' consciousness is impaired" had significant positive correlations with the use of medications. CONCLUSION: Pharmacological management of hypoactive delirium in the last days of life differs depending on physicians' beliefs. Future research is needed to clarify the efficacy and safety of pharmacological management of hypoactive delirium.

Development and Validation of the Death Pronouncement Burden Scale for Oncology Practice.

Background: Informing families of a patient's death is one of the most challenging responsibilities of clinicians who provide care for terminally ill patients. Although death pronouncement can be a highly stressful event for clinicians, no previous study has reported qualitative characteristics of the burden experienced by clinicians related to death pronouncements. Moreover, no scale has been developed to assess this burden. Objective: This study sought to develop a scale to evaluate clinicians' burden related to death pronouncement (Death Pronouncement Burden Scale for oncology practice [DPBS-oncol]) and examine its reliability and validity in Japan. Methods: We presented the DPBS-oncol to clinicians involved in oncology practice and examined its reliability and discriminant validity. To investigate the test-retest reliability of the scale, the DPBS-oncol was presented a second time to a subsample of the clinicians. Results: Factor analysis required a grouping of the 15 DPBS-oncol items into one factor. Cronbach's α coefficient of the total score of DPBS-oncol was 0.94, and the intraclass correlation coefficient of the total score of DPBS-oncol was 0.89. Regarding discriminant validity, DPBS-oncol total score was moderately correlated with other available scales for assessing clinicians' attitudes to end-of-life care. Conclusion: This study was the first to develop a scale to evaluate clinicians' burden related to death pronouncement. The DPBS-oncol, which includes 15 items, was validated and shown to have sufficient reliability.

Current practice of pharmacological treatment for hyperactive delirium in terminally ill cancer patients: results of a nationwide survey of Japanese palliative care physicians and liaison psychiatrists.

OBJECTIVE: The objective of this survey was to identify areas where doctors have divergent practices in pharmacological treatment for hyperactive delirium in terminally ill patients with cancer. METHODS: We conducted a survey of Japanese palliative care physicians and liaison psychiatrists. Inquiries were made regarding: (i) choice of drug class in the first-line treatment, (ii) administration methods of the first-line antipsychotic treatment, (iii) starting dose of antipsychotics in the first line treatment and maximum dose of antipsychotics in refractory delirium, and (iv) choice of treatment when the first-line haloperidol treatment failed. Respondents used a five-point Likert scale. RESULTS: Regarding choice of drug class in the first-line treatment, more doctors reported that they 'frequently' or 'very frequently' use antipsychotics only than antipsychotics and benzodiazepine (oral: 73.4 vs. 12.2%; injection: 61.3 vs. 11.6%, respectively). Regarding administration methods of the first-line antipsychotic treatment, the percentage of doctors who reported that they used antipsychotics as needed and around the clock were 55.4 and 68.8% (oral), 49.2 and 45.4% (injection), respectively. There were different opinions on the maximum dose of antipsychotics in refractory delirium. Regarding the choice of treatment when the first-line haloperidol treatment failed, the percentage of doctors who reported that they increased the dose of haloperidol, used haloperidol and benzodiazepines, and switched to chlorpromazine were 47.0, 32.1 and 16.4%, respectively. CONCLUSIONS: Doctors have divergent practices in administration methods of the first-line antipsychotic treatment, maximum dose of antipsychotics, and choice of treatment when the first-line haloperidol treatment failed. Further studies are needed to determine the optimal treatment.

Appropriate referral timing to specialized palliative care service: survey of bereaved families of cancer patients who died in palliative care units.

Few studies have investigated appropriate referral timing of specialized palliative care (SPC) from the perspective of cancer patients' and families' experiences. We aimed to clarify appropriate SPC referral timing for patients with advanced cancer and their families. We used data from a nationwide bereaved family survey in Japan. We sent a questionnaire to 999 bereaved families of cancer patients who died in 164 palliative care units (PCUs) and analyzed the first SPC referral timing and how patients evaluated it. We defined SPC as outpatient or inpatient palliative care service comprising certified palliative care physicians, advanced-practice nurses, and multidisciplinary practitioners. Finally, 51.6% (n = 515) of all responses were analyzed. The SPC referral timing was evaluated as appropriate (26.1%), late or too late (20.2%), early or too early (1.2%), or none of these (52.5%). Of these, 32.3% reported that they were referred to an SPC when diagnosed with advanced or incurable cancer or during anti-cancer treatment, and 62.6% reported they were referred after anti-cancer treatment. Patient-perceived appropriateness of SPC referral timing was associated with their good death process. After excluding "none of these" responses, a significantly higher proportion of respondents who reported being referred to SPC at diagnosis and during anti-cancer treatment evaluated the response timing as appropriate, compared to those who reported being referred after anti-cancer treatment. Appropriate timing for SPC referrals relates to quality of death; findings suggest that appropriate timing is at the time of diagnosis or during anti-cancer treatment.

Dexamethasone 8 mg for Cancer-Related Fatigue in Inpatients with Advanced Cancer Undergoing Palliative Care: A Multicenter Phase II Trial.

Objective: No standard treatment for cancer-related fatigue (CRF) for inpatients in a palliative care setting exists. The aim of this study was to validate the previous study-derived efficacy of dexamethasone 8 mg for CRF among inpatients in a palliative care setting. Methods: Inpatients with moderate fatigue (≥4/10) were enrolled in a multicenter phase II trial. Dexamethasone 8 mg p.o. or 6.6 mg i.v. was administered for seven days and 4 mg p.o. or 3.3 mg i.v. for seven consecutive days. The primary endpoint was a threshold average change of Functional Assessment of Chronic Illness Therapy (FACIT)-fatigue subscale score of 3. The secondary endpoints were evaluated with the anorexia-cachexia subscale (ACS), and the Edmonton symptom assessment scale-revised Japanese version. Results: A total of 32 patients were enrolled. On day 8, the mean change of FACIT-fatigue subscale from day 1 was 5.2 (95% confidence interval 0.8-10.0), in which the lower bound was above 0 but not above the prespecified threshold value of 3.0 (p = 0.72). Edmonton symptom assessment system (ESAS)-fatigue was significantly improved by day 3 (p = 0.02), but not on day 8 or day 15. ACS, physical well-being, and ESAS-lack of appetite significantly improved by day 8 and day 15. Adverse events were tolerable. Conclusion: This study showed that dexamethasone 8 mg failed to achieve the preset efficacy for CRF among inpatients in a palliative care setting. However, this treatment improved fatigue and would be an option for CRF. jRCT (jRCTs031180068).

Is the 1-day surprise question a useful screening tool for predicting prognosis in patients with advanced cancer?-a multicenter prospective observational study.

BACKGROUND: For cancer patients nearing death, the prediction of their prognosis by physicians is crucial. This study examined the usefulness of the 1-Day Surprise Question (1DSQ). METHODS: This study was conducted as part of a multicenter prospective observational study. The physicians answered the 1DSQ "Would I be surprised if this patient died in the next 1 day?" when patients have palliative performance scale (PPS) ≤20. We calculated the sensitivity and specificity of the 1DSQ. Moreover, using multivariate analysis, we evaluated the characteristics of patients who died among those whose physicians answered the 1DSQ as "not surprised". RESULTS: Overall, 1,896 patients were enrolled, and 1,411 (74.4%) were analyzed between January and December 2017. Among these, 847 (60.0%) patients were placed in the "not surprised" group. The sensitivity, specificity, and positive and negative predictive values of the 1DSQ were 82.0% [95% confidence interval (CI): 77.5-85.8%], 45.5% (95% CI: 44.4-46.4%), 27.4% (95% CI: 25.9-28.7%), and 91.0% (95% CI: 88.9-92.9%), respectively. Multivariate analysis revealed that urine output over last 12 hours <100 mL, decreased response to visual stimuli, respiration with mandibular movement, pulselessness of radial artery, and saturation of percutaneous oxygen <90% were characteristics of patients who died as predicted by the physicians. CONCLUSIONS: The 1DSQ is a helpful screening tool for identifying cancer patients with impending death.

Tapentadol Safety and Patient Characteristics Associated with Treatment Discontinuation in Cancer Therapy: A Retrospective Multicentre Study in Japan.

INTRODUCTION: Tapentadol has analgesic effects comparable to those of conventional opioids and is associated with fewer side effects, including gastrointestinal symptoms, drowsiness, and dizziness, than other opioids. However, the safety of tapentadol in the Japanese population remains unclear; the present multicentre study aimed to examine the safety of tapentadol and the characteristics of patients likely to discontinue this treatment owing to adverse events. METHODS: The safety of tapentadol was assessed retrospectively in patients with any type of cancer treated between August 18, 2014 and October 31, 2019 across nine institutions in Japan. Patients were examined at baseline and at the time of opioid discontinuation. Multivariate analysis was performed to identify factors associated with tapentadol discontinuation owing to adverse events. RESULTS: A total of 906 patients were included in this study, and 685 (75.6%) cases were followed up until tapentadol cessation for any reason. Among patients who discontinued treatment, 119 (17.4%) did so because of adverse events. Among adverse events associated with difficulty in taking medication, nausea was the most common cause of treatment discontinuation (4.7%), followed by drowsiness (1.8%). Multivariate analysis showed that those who were prescribed tapentadol by a palliative care physician (odds ratio [OR] 2.60, 95% confidence interval [CI] 1.36-4.99, p = 0.004), patients switching to tapentadol due to side effects from previous opioids (OR 2.19, 95% CI 1.05-4.56, p = 0.037), and patients who did not use naldemedine (OR 5.06, 95% CI 2.47-10.37, p < 0.0001) had an increased risk of treatment discontinuation owing to adverse events. CONCLUSIONS: This study presents the safety profile of tapentadol and the characteristics of patients likely to discontinue this treatment owing to adverse events in the Japanese population. Prospective controlled trials are required to evaluate the safety of tapentadol and validate the present findings. TRIAL REGISTRATION NUMBER: UMIN 000044282 (University Hospital Medical Information Network).