Treatment Patterns and Postoperative Activities of Daily Living in Patients with Non-small Cell Lung Cancer: A Retrospective Study Using Nationwide Health Services Utilization Data in Japan.

BACKGROUND: The number of older patients with cancer has been increasing. This study aimed to determine the proportion of postoperative decline in activities of daily living (ADL), hospital mortality rate, home healthcare services use, and adjuvant chemotherapy treatment patterns of patients with early-stage non-small cell lung cancer (NSCLC) across age groups. METHODS: We analyzed health service utilization data of patients aged ≥ 40 years diagnosed with clinical stage I or II NSCLC in 2015 who underwent thoracoscopy or thoracotomy. The Barthel index was used to determine the proportions of patients aged 40-64, 65-74, ≥ 75 years who experienced a decline in the ADL of ≥ 10 points at postoperative discharge compared to the ADL at admission. RESULTS: Overall, 19,780 patients were analyzed. The proportion of patients with ADL decline slightly increased with increasing age: 1.1%, 1.6%, and 3.5% after thoracoscopic surgery, and 1.4%, 2.8%, and 4.8% after thoracotomy among those aged 40-64, 65-74, and ≥ 75 years, respectively. The hospital mortality rate and proportion of home healthcare services use was fewer than 10 cases, or < 2%. The unexpected readmission rate was slightly higher among those aged ≥ 75 years (3.7% for thoracoscopic surgery, 4.7% for thoracotomy) than among those aged 40-64 years (1.8% for thoracoscopic surgery, 2.5% for thoracotomy). CONCLUSION: The difference in the proportion of patients with ADL decline between those aged 40-64 and ≥ 75 years was approximately 3%. This study provides practical information for clinicians involved in the care of older patients who undergo thoracic surgery.

Effectiveness of antipsychotics for managing agitated delirium in patients with advanced cancer: a secondary analysis of a multicenter prospective observational study in Japan (Phase-R).

PURPOSE: Delirium is a common and serious comorbidity in patients with advanced cancer, necessitating effective management. Nonetheless, effective drugs for managing agitated delirium in patients with advanced cancer remain unclear in real-world settings. Thus, the present study aimed to explore an effective pharmacotherapy for this condition. METHODS: We conducted a secondary analysis of a multicenter prospective observational study in Japan. The analysis included patients with advanced cancer who presented with agitated delirium and received pharmacotherapy. Agitation was defined as a score of the Richmond Agitation-Sedation Scale for palliative care (RASS-PAL) of ≥ 1. The outcome was defined as -2 ≤ RASS-PAL ≤ 0 at 72 h after the initiation of pharmacotherapy. Multiple propensity scores were quantified using a multinomial logistic regression model, and adjusted odds ratios (ORs) were calculated for haloperidol, chlorpromazine, olanzapine, quetiapine, and risperidone. RESULTS: The analysis included 271 patients with agitated delirium, and 87 (32%) showed -2 ≤ RASS-PAL ≤ 0 on day 3. The propensity score-adjusted OR of olanzapine was statistically significant (OR, 2.91; 95% confidence interval, 1.12 to 7.80; P = 0.030). CONCLUSIONS: The findings suggest that olanzapine may effectively improve delirium agitation in patients with advanced cancer.

Behavioral activation for depression in patients with advanced cancer: study protocol for a multicenter randomized controlled trial.

BACKGROUND: Though behavioral activation (BA) has been shown to be effective for depression, evidence in patients with advanced cancer has not been established. This study aimed to examine the effectiveness of a BA program on depression in this population. METHODS: A randomized controlled trial with a wait-list control group (waiting group) of 38 patients with advanced cancer and depression will be conducted at three sites in Japan. The BA program consists of seven sessions. Outcome measures will be evaluated at three times in the intervention group; at the entry, at the end of the intervention and 4 months after the end of the intervention and four times in the waiting group: at the entry, before the intervention, at the end of the intervention, and 4 months after the end of the intervention. Primary outcome is Beck Depression Inventory-II (BDI-II) score. To examine the main effect of the intervention, two-way repeated measures analysis of variance (ANOVA) will be conducted, with timing and intervention status as the independent variables and BDI-II score as the dependent variable. One-way repeated measures ANOVA will be conducted to combine data from the intervention and control groups and examine changes in BDI-II scores by timing in both groups. Secondary endpoints (anxiety, quality of life, spirituality, degree of behavioral activation, value, and pain) will be evaluated with rating scales. Two-way repeated measures ANOVA will be conducted to examine whether there are differences between the groups before and after the intervention, with timing and intervention status as the independent variables and scores on each rating scale as the dependent variables. DISCUSSION: This multicenter randomized controlled trial is the first study to assess the effectiveness of BA on depression in patients with advanced cancer. Our findings will provide evidence about the effectiveness of BA on depression and provide an intervention option that is acceptable and feasible for the treatment of depression in this population. The results of this study will lead to improved mood and rebuilding to regain life purpose and value in this vulnerable population. TRIAL REGISTRATION NUMBER: jRCT, jRCT1030210687, Registered 22 March 2022, https://jrct.niph.go.jp/en-latest-detail/jRCT1030210687 .

Influence of dosing pattern of antipsychotics on treatment outcome of delirium in patients with advanced cancer.

BACKGROUND: Clinical guidelines recommend antipsychotics for the treatment of delirium; however, there has been no confirmed recommendation regarding their administrating patterns. This study aims to investigate whether different dosing patterns of antipsychotics (single or multiple administrations) influence the outcomes of delirium treatment. METHODS: This is a secondary analysis of a prospective observational study involving patients with advanced cancer and delirium receiving antipsychotics. The Delirium Rating Scale Revised-98 was administered at baseline and after 72 h of starting pharmacotherapy. Patients were classified into single administration group (received a single dosage within 24 h before the assessment) and multiple administration group (received more than one dosage). RESULTS: A total of 555 patients (single administration 492 (88.6%); multiple administration 63 (11.4%)) were subjected to analyses. The patients in the multiple administration group were more likely to be male, in psycho-oncology consulting settings, with lower performance status, with hyperactive delirium and with severer delirium symptoms. In the multivariate analysis, single administration was significantly associated with better improvement of delirium (p < 0.01, 95% confidence interval: 1.83-5.87) even after controlling covariates. There were no significant differences in the mean dosages of antipsychotics per day in chlorpromazine equivalent (single administration 116.8 mg/day, multiple administration 123.5 mg/day) and the incidence of adverse events between the two groups. CONCLUSIONS: In this observational study sample, Delirium Rating Scale severity score improvement in single administration was higher than that seen in multiple administration. There was no difference in adverse events between the two groups.

A revision of JPOS/JASCC clinical guidelines for delirium in adult cancer patients: a summary of recommendation statements.

OBJECTIVE: The Japanese Psycho-Oncology Society and the Japanese Association of Supportive Care in Cancer have recently revised the clinical practice guidelines for delirium in adult cancer patients. This article reports the process of developing the revised guidelines and summarizes the recommendations made. METHODS: The guidelines were developed in accordance with the Medical Information Network Distribution Service creation procedures. The guideline development group, consisting of multi-disciplinary members, created three new clinical questions: non-pharmacological intervention and antipsychotics for the prevention of delirium and trazodone for the management of delirium. In addition, systematic reviews of nine existing clinical questions have been updated. Two independent reviewers reviewed the proposed articles. The certainty of evidence and the strength of the recommendations were graded using the grading system developed by the Medical Information Network Distribution Service, following the concept of The Grading of Recommendations Assessment, Development, and Evaluation system. The modified Delphi method was used to validate the recommended statements. RESULTS: This article provides a compendium of the recommendations along with their rationales, as well as a short summary. CONCLUSIONS: These revised guidelines will be useful for the prevention, assessment and management of delirium in adult cancer patients in Japan.

A multi-centre, double-blind, randomized, placebo-controlled trial to evaluate the effectiveness and safety of ramelteon for the prevention of postoperative delirium in elderly cancer patients: a study protocol for JORTC-PON2/J-SUPPORT2103/NCCH2103.

Postoperative delirium is an important issue in cancer patients, affecting surgical outcomes and the quality of life. Ramelteon is a melatonin receptor agonist with high affinity for MT1 and MT2 receptors. Clinical trials and observational studies in Japan, including in surgical cancer patients, have shown efficacy of ramelteon in delirium prevention, with no serious safety concerns. However, clinical trials from the USA have reported conflicting results. A Japanese phase II study investigated the efficacy and safety of ramelteon for delirium prevention following gastrectomy in patients aged ≥75 years, with findings suggesting the feasibility of a phase III trial. The aim of this multi-centre, double-blind, randomized placebo-controlled phase III trial is to evaluate the effectiveness and safety of oral ramelteon for postoperative delirium prevention in cancer patients aged ≥65 years as advanced medical care. The trial protocol is described here.

Association of physical restraint duration and undesirable outcomes amongst inpatients comorbid with dementia and pneumonia in acute care settings.

AIMS AND OBJECTIVES: This study aimed to examine the association between physical restraint duration and undesirable outcomes amongst inpatients comorbid with dementia and pneumonia in acute care hospitals. BACKGROUND: Physical restraints are frequently used in the management of patients, especially amongst patients with dementia. No previous study investigated the potential undesirable effects of physical restraints in patients with dementia. METHODS: This was a cohort study using a nationwide discharge abstract database in Japan. Patients aged ≥65 years with dementia hospitalised for pneumonia or aspiration pneumonia between April 1, 2016 and March 31, 2019 were identified. The exposure was physical restraint. The primary outcome was hospital discharge to the community. Secondary outcomes included hospitalisation costs, functional decline, in-hospital mortality, and institutionalisation for long-term care. RESULTS: A total of 18,255 inpatients with pneumonia and dementia in 307 hospitals were included in this study. Of them, 21.5% and 23.7% had physical restraint during full and partial days of hospital stays, respectively. Discharge to the community incidence rates was lower in the full-restraint vs. the no-restraint group (27 vs. 29 per 1000 person-days; HR, 1.05 [95% CI, 1.01-1.10]) and the partial-restraint vs. the no-restraint group (17 vs. 29 per 1000 person-days; HR, 1.79 [95% CI, 1.71-1.87]). The risks of functional decline were higher in the full-restraint vs. the no-restraint group (27.8% vs. 20.8%; RR, 1.33 [95% CI, 1.22, 1.46]) and the partial-restraint vs. the no-restraint group (29.2% vs. 20.8%; RR, 1.40 [95% CI, 1.29, 1.53]). CONCLUSIONS: The use of physical restraints was associated with a lower incidence rate of discharge to the community and an increased risk of functional decline at discharge. Further research is needed to judge the benefit-risk balance of physical restraints in acute care settings. RELEVANCE TO CLINICAL PRACTICE: Understanding the risk of physical restraints allows medical staff to improve the process of decision making in everyday practice. No Patient or Public Contribution. REPORTING METHODS: The reporting of this article conforms to the STROBE statement.

Early specialized palliative care for patients with metastatic lung cancer receiving chemotherapy: a feasibility study of a nurse-led screening-triggered programme.

BACKGROUND: Strategies to implement early specialized palliative care have not yet been established. The present study investigated the feasibility of a nurse-led, screening-triggered early specialized palliative care intervention programme and obtained data to design a randomized controlled trial. METHODS: Patients with metastatic lung cancer undergoing first-line platinum-based chemotherapy were eligible. The intervention consisted of (1) a questionnaire-based screening programme and (2) advanced-level nurse counselling and care coordination with interdisciplinary team approach. The primary endpoint was the completion rate of the assessment questionnaire after the second course of first-line chemotherapy (T2). Secondary endpoints included changes in Functional Assessment of Cancer Therapy-Lung scores, depression and anxiety rates based on the Patient Health Questionnaire 9 and the Hospital Anxiety and Depression Scale, and the contents of specialized palliative care. RESULTS: A total of 50 patients were enrolled between August 2012 and March 2014. Median age was 66 years (range, 40-78 year) and 84% were male. A total of 38 patients had stage IV non-small cell lung carcinoma and 12 had extensive disease small-cell lung carcinoma. The completion rate was 70% (95% confidence interval 56.0-81.0). The median duration between baseline and T2 was 53 days. Improvement from baseline were observed at T2 in Functional Assessment of Cancer Therapy-Lung scores (86.0 ± 18.1 vs 94.9 ± 18.2, P = 0.057), depression (16.0 vs 5.7%; P = 0.26) and anxiety (32.0 vs 22.9%; P = 0.65); however, these results were not statistically significant. CONCLUSIONS: This early specialized palliative care intervention is feasible and could be useful in improving patients' quality of life. The present results justify the initiation of a randomized control trial.

Safety and Effectiveness of Perospirone in Comparison to Risperidone for Treatment of Delirium in Patients with Advanced Cancer: A Multicenter Prospective Observational Study in Real-World Psycho-Oncology Settings.

The clinical benefit of perospirone for treatment of delirium in patients with advanced cancer is not sufficiently clear. The objective of this study was to compare the safety and effectiveness of perospirone to those of risperidone for the treatment of delirium in patients with advanced cancer. This is a secondary analysis of a multicenter prospective observational study in nine psycho-oncology consultation services in Japan. The study used the Delirium Rating Scale (DRS) Revised-98 to measure effectiveness and the CTCAE (Common Terminology Criteria for Adverse Events) version 4 to assess safety. Data from 16 patients who received perospirone and 53 patients who received risperidone were analyzed. The mean age was 70 years in the perospirone group and 73 years in the risperidone group. Both groups showed a significant decrease in the total score of DRS-R-98 after three days of treatment (perospirone: 11.7 (7.9-15.4) to 7.0 (3.3-10.7), difference -4.7, effect size=0.72, p=0.003; risperidone: 15.5 (13.6-17.4) to 12.2 (10.1-14.2), difference -3.3, effect size=0.55, p=0.00). The risperidone group showed significant improvements in sleep-wake cycle disturbance, orientation, attention, and visuospatial ability. In the perospirone group, there was a significant improvement of sleep-wake cycle disturbance. The median daily dose of perospirone was 4 mg/day. There were fewer episodes of somnolence as an adverse event in the perospirone group. Low-dose perospirone was thus found to be effective for the treatment of delirium in patients with advanced cancer and may be associated with fewer episodes of over-sedation as an adverse event.

A decision tree prediction model for a short-term outcome of delirium in patients with advanced cancer receiving pharmacological interventions: A secondary analysis of a multicenter and prospective observational study (Phase-R).

OBJECTIVE: There is no widely used prognostic model for delirium in patients with advanced cancer. The present study aimed to develop a decision tree prediction model for a short-term outcome. METHOD: This is a secondary analysis of a multicenter and prospective observational study conducted at 9 psycho-oncology consultation services and 14 inpatient palliative care units in Japan. We used records of patients with advanced cancer receiving pharmacological interventions with a baseline Delirium Rating Scale Revised-98 (DRS-R98) severity score of ≥10. A DRS-R98 severity score of <10 on day 3 was defined as the study outcome. The dataset was randomly split into the training and test dataset. A decision tree model was developed using the training dataset and potential predictors. The area under the curve (AUC) of the receiver operating characteristic curve was measured both in 5-fold cross-validation and in the independent test dataset. Finally, the model was visualized using the whole dataset. RESULTS: Altogether, 668 records were included, of which 141 had a DRS-R98 severity score of <10 on day 3. The model achieved an average AUC of 0.698 in 5-fold cross-validation and 0.718 (95% confidence interval, 0.627-0.810) in the test dataset. The baseline DRS-R98 severity score (cutoff of 15), hypoxia, and dehydration were the important predictors, in this order. SIGNIFICANCE OF RESULTS: We developed an easy-to-use prediction model for the short-term outcome of delirium in patients with advanced cancer receiving pharmacological interventions. The baseline severity of delirium and precipitating factors of delirium were important for prediction.

Essential competences for psychologists in palliative cancer care teams.

The study aim was to clarify the essential competencies for psychologists in palliative care teams. A nationwide, multicentre cross-sectional survey was conducted. A 32-item questionnaire assessing endorsement of potential competencies was completed by 70 patients and/or families, 101 consulting personnel, 747 members of palliative care teams and 203 mental health providers. All 32 competencies were judged as essential. Of the 32 items, 9 and 28 items were endorsed by >95% and 80% of participants, respectively. The most frequently endorsed essential competency was ability to coordinate with other professionals in palliative care teams. Some competencies considered essential seemed specific to oncology and medical settings. The results suggest the need for specific guidance for psychologists working in palliative care teams and the development of clinical oncology training programmes and/or systems for psychologists.

Conditions, possibility and priority for admission into inpatient hospice/palliative care units in Japan: a nationwide survey.

BACKGROUND: Known barriers to admission into inpatient hospice/palliative care units (PCUs) include poor accessibility and stringent conditions for admission. However, the exact criteria are unclear. The aim of this study was to clarify the actual conditions, possibilities and priorities for admission to PCU in Japan. METHODS: We conducted a nationwide, anonymous, self-administered questionnaire survey to the responsible physicians of all 251 PCUs in 2014. RESULTS: Responses were received from 190 institutions (response rate 76%). The most frequent condition for admission was 'either the patient or the family knows the diagnosis' [86%, 95% confidence interval (CI): 80-90]. For the conditions for admission to PCU, 10-40% fewer facilities answered that the patient's consent or understanding was required compared with those that answered the patient or family's consent was sufficient. Seventy-one percent (95% CI: 64-77) of PCUs answered that either the patient or a family member needed to agree to a do-not-resuscitate (DNR) policy. The factors most likely to result in refusal of admission to a PCU varied greatly. Ninety-four percent (95% CI: 90-97) of PCUs answered that patients who had undergone a long waiting time after applying for admission would be given higher priority, and approximately 50% of PCUs answered they gave priority to their outpatients and inpatients. CONCLUSIONS: The findings of this study should be used to modify the system so that appropriate palliative care can be provided to patients who wish to be admitted to PCU.

Are common delirium assessment tools appropriate for evaluating delirium at the end of life in cancer patients?

OBJECTIVES: The objectives of this study are to investigate how many advanced cancer patients became unconscious or non-communicative after pharmacological treatment for delirium, and to explore whether existing delirium assessment tools can successfully evaluate its severity at the end of life. METHODS: This was a secondary analysis of a registry study that examined the efficacy and safety of antipsychotics for advanced cancer patients with delirium. A total of 818 patients were recruited from 39 specialized palliative care services in Japan. The severity of delirium was measured using the Richmond Agitation-Sedation Scale-Palliative care version, the Delirium Rating Scale-Revised-98 (DRS-R-98), and the Nursing Delirium Screening Scale (Nu-DESC) on Day 3. Data from 302 patients with motor anxiety with an Agitation Distress Scale score ≥2 on Day 0 were analyzed for this study. The patients were categorized into four treatment response groups: complete response (CR: no agitation and fully communicative), partial response (PR: no/mild agitation and partially communicative), unconscious/non-communicative (UC), and no change (NC). RESULTS: On Day 3, 29 (10%; 95% confidence intervals [CI], 7-13) and 2 (1%; 95% CI, 0-2) patients became unconscious and non-communicative, respectively. Forty-four patients were categorized as CR, 97 as PR, 31 as UC, and 96 as NC. The scores of the DRS-R-98 and Nu-DESC in the UC group were rated higher than patients in the NC group were. CONCLUSIONS: A considerable number of cancer patients with delirium became unconscious or non-communicative. Existing delirium assessment tools may be inappropriate for measuring the severity of delirium in end-of-life.

Availability of home palliative care services and dying at home in conditions needing palliative care: A population-based death certificate study.

BACKGROUND: Avoiding inappropriate care transition and enabling people with chronic diseases to die at home have become important health policy issues. Availability of palliative home care services may be related to dying at home. AIM: After controlling for the presence of hospital beds and primary care physicians, we examined the association between availability of home palliative care services and dying at home in conditions requiring such services. DESIGN: Death certificate data in Japan in 2016 were linked with regional healthcare statistics. SETTING/PARTICIPANTS: All adults (18 years or older) who died from conditions needing palliative care in 2016 in Japan were included. RESULTS: There were 922,756 persons included for analysis. Malignant neoplasm (37.4%) accounted for most decedents, followed by heart disease including cerebrovascular disease (31.4%), respiratory disease (14.7%) and dementia/Alzheimer's disease/senility (11.5%). Of decedents, 20.8% died at home or in a nursing home and 79.2% died outside home (hospital/geriatric intermediate care facility). Death at home was more likely in health regions with fewer hospital beds and more primary care physicians, in total and per condition needing palliative care. Number of home palliative care services was negatively associated with death at home. The adjustment for home palliative care services disappeared in heart disease including cerebrovascular disease and reversed in respiratory disease. CONCLUSION: Specialised home palliative care services may be suboptimal, and primary care services may serve as a key access point in providing baseline palliative care to people with conditions needing palliative care. Therefore, primary care services should aim to enhance their palliative care workforce.

Treatment Optimization for Hepatocellular Carcinoma in Elderly Patients in a Japanese Nationwide Cohort.

OBJECTIVE: We reviewed nationwide follow-up data to determine outcomes of different treatments for early-stage hepatocellular carcinoma (HCC) in elderly patients. SUMMARY BACKGROUND DATA: Outcomes of early-stage HCC treatments in elderly patients have not been prospectively compared. METHODS: We included 6490 HCC patients, aged ≥75 years at treatment, who underwent curative hepatic resection (HR, n = 2020), radiofrequency ablation (RFA, n = 1888), microwave ablation (MWA, n = 193), or transcatheter arterial chemoembolization (TACE, n = 2389), and compared their characteristics and survival. We used matching propensity score analysis (PSA) between the HR and RFA subgroups with tumors ≤3 cm to overcome baseline bias. RESULTS: The HR group had significantly longer recurrence-free survival (RFS) than the RFA, MWA, and TACE groups [RFA vs HR-hazard ratio: 1.22, 95% confidence interval (CI): 1.09-1.37, P < 0.001; MWA vs HR-hazard ratio: 1.51, 95% CI: 1.22-1.88, P < 0.001; TACE vs HR-hazard ratio: 2.70, 95% CI: 2.44-2.99, P < 0.001). HR and RFA patients had significantly longer overall survival (OS) than the TACE group (RFA vs HR-hazard ratio: 1.01, 95% CI: 0.87-1.17, P = 0.919, TACE vs HR-hazard ratio: 2.11, 95% CI: 1.86-2.40, P < 0.001). PSA successfully matched HR and RFA patients from with primary HCC tumors ≤3.0 cm and similar liver function and tumor characteristics; and showed significantly longer RFS (hazard ratio: 1.64, 95% CI: 1.29-2.10, P < 0.001) and OS (hazard ratio: 1.57, 95% CI: 1.12-2.20, P = 0.009) for HR than for RFA (including subgroup analyses). In Cox proportional hazard analysis, HR offered better prognosis than RFA. CONCLUSIONS: HR decreases recurrence risk and improves OS in patients aged ≥75 years with primary HCC tumors ≤3.0 cm.

Current Pharmacotherapy Does Not Improve Severity of Hypoactive Delirium in Patients with Advanced Cancer: Pharmacological Audit Study of Safety and Efficacy in Real World (Phase-R).

BACKGROUND: Pharmacotherapy is generally recommended to treat patients with delirium. We sought to describe the current practice, effectiveness, and adverse effects of pharmacotherapy for hypoactive delirium in patients with advanced cancer, and to explore predictors of the deterioration of delirium symptoms after starting pharmacotherapy. SUBJECTS, MATERIALS, AND METHODS: We included data of patients with advanced cancer who were diagnosed with hypoactive delirium and received pharmacotherapy for treatment of delirium. This was a pharmacovigilance study characterized by prospective registries and systematic data-recording using internet technology, conducted among 38 palliative care teams and/or units. The severity of delirium and other outcomes were assessed using established measures at days 0 (T0), 3 (T1), and 7 (T2). RESULTS: Available data were obtained from 218 patients. The most frequently used agent was haloperidol (37%). A total of 67 and 42 patients (31% and 19%) had died or discontinued pharmacotherapy by T1 and T2, respectively. Delirium symptoms deteriorated between T0 and T1, but this trend did not reach statistical significance. The most prevalent adverse event was sedation (9%). Delirium severity worsened after starting pharmacotherapy in 121 patients (56%) at T1. In patients whose death was expected within a few days and those with delirium caused by organ failure, symptoms of delirium were significantly more likely to deteriorate after starting pharmacotherapy. CONCLUSION: Current pharmacotherapy for hypoactive delirium in patients with advanced cancer is not recommended, especially in those whose death is expected within a few days and in those with delirium caused by organ failure. IMPLICATIONS FOR PRACTICE: Delirium is common among patients with advanced cancer, and hypoactive delirium is the dominant motor subtype in the palliative care setting. Pharmacotherapy is recommended and regularly used to treat delirium. This article describes the effectiveness and adverse effects of pharmacotherapy for hypoactive delirium in patients with advanced cancer. The findings of this study do not support the use of pharmacotherapy for treatment of hypoactive delirium in the palliative care setting. Pharmacotherapy should especially be avoided in patients whose death is expected within a few days and in those with delirium caused by organ failure.

Geriatric Research Policy: Japan Clinical Oncology Group (JCOG) policy.

Due to the rapid aging of Japan's population, clinical research focusing on older patients with cancer is urgently needed. The Japan Clinical Oncology Group (JCOG) has conducted several such clinical trials, but there has been no formal policy for geriatric research. We have therefore established a JCOG policy for geriatric cancer research. We defined the patient selection policy based on treatment tolerance and chronological age. Older patients are categorized into three conceptual groups: 'fit patients' who can undergo the same standard treatment given to younger patients, 'frail patients' for whom best supportive or palliative care is indicated and 'vulnerable patients' who fall between the fit and frail categories. Unmet needs often exist for vulnerable patients. The policy recommends that study endpoints include not only survival but also other endpoints such as physical and cognitive function because the objective of therapy in older patients is not only extended life expectancy but also maintenance of the patient's general condition. In this viewpoint, co-primary or composite endpoints that incorporate geriatric assessment in the study design are often applicable. Study design will differ depending on the study population, clinical question, and treatment. Even for older patients, a randomized clinical trial is still the gold standard when the clinical question asks which treatment is better. An observational study of a broader population is applicable for investigating actual conditions of older patients. This JCOG Geriatric Research Policy includes several practical solutions for various issues in geriatric research. We plan to revise this policy periodically to guide future geriatric research.

Posttraumatic growth in bereaved family members of patients with cancer: a qualitative analysis.

BACKGROUND: The death of a loved one has great impact on family members even when the death was expected. While negative changes are reported, some individuals also report personal growth, known as posttraumatic growth (PTG). Many studies on PTG have been performed using quantitative methods and suggest that PTG may differ according to the traumatic event and cultural background. PURPOSE: This study aimed to explore how Japanese bereaved family members of patients with cancer express their experience of PTG after the patient's death by analyzing open-ended answers provided in a cross-sectional survey. METHODS: Qualitative data were collected through a survey, and thematic analysis was used to analyze the data. The present study was part of a larger cross-sectional survey of bereaved families of patients with cancer. Data analyzed in the current study were obtained from 162 bereaved family members of patients with cancer. RESULTS: We identified 18 sub-themes within five predefined major domains of PTG. Moreover, we also identified two additional themes: changed view of life and death, and awareness of health management. CONCLUSIONS: The experience of PTG of bereaved family members varied considerably. Future research on PTG experiences among groups from diverse cultural backgrounds would be beneficial for understanding the concept and its clinical implications.

What determines the timing of discussions on forgoing anticancer treatment? A national survey of medical oncologists.

PURPOSE: End-of-life discussions (EOLd) including the option of forgoing anticancer treatment infrequently occur until treatment options have been exhausted for advanced cancer patients. We aimed to identify oncologist-related factors contributing to the timing of discussing the option of forgoing anticancer treatment. METHODS: In this nationwide survey of 864 medical oncologists, we asked about physicians' attitudes toward the timing of discussing the option of forgoing anticancer treatment for a simulated patient with newly diagnosed metastatic cancer, physicians' experience of EOLd, perceptions of a good death, and beliefs. Multivariate analyses identified determinants of early discussions. RESULTS: Among 490 physicians (response rate = 57%), 167 (35%) would discuss the option of forgoing anticancer treatment "now (at the diagnosis)." Physicians' attitudes toward discussing the option "now" were significantly correlated with a greater physician-perceived importance of life completion (odds ratio (OR) = 1.30, 95%CI = 1.00-1.69, p = 0.048) and dying in a preferred place (OR = 1.29, 95%CI = 1.01-1.65, p = 0.045) for a good death, and not perceiving EOLd as being severely distressing for patients/families (OR = 0.70, 95%CI = 0.54-0.95, p = 0.021). In multivariate analyses, independent determinants of the attitude toward discussing the option now included a greater physician-perceived importance of life completion for a good death (OR = 1.38, 95%CI = 1.05-1.81, p = 0.019), and not perceiving EOLd as being severely distressing for patients/families (OR = 0.70, 95%CI = 0.52-0.94, p = 0.017). CONCLUSIONS: Reflection by oncologists on their own perception regarding a good death and beliefs about EOLd may help oncologists individualize the timing of discussing the option of forgoing anticancer treatment.

Quality of care in hospitalized cancer patients before and after implementation of a systematic prevention program for delirium: the DELTA exploratory trial.

BACKGROUND: We evaluated whether the DELirium Team Approach (DELTA) program-a systematic management program aimed at screening high-risk groups and preventing delirium-would improve quality of care in patients hospitalized with cancer. METHODS: A retrospective before-after study was conducted during a pre-intervention period (between October 2012 and March 2013) and a post-intervention period (between October 2013 and March 2014) at a Japanese hospital providing specialized treatments for cancer. A total of 4180 inpatients were evaluated before the implementation of the DELTA program and 3797 inpatients were evaluated after implementation. RESULTS: After program implementation, the incidence of delirium decreased from 7.1 to 4.3% (odds ratio [OR], 0.52; 95% CI, 0.42-0.64). The incidence of adverse events, including falls or self-extubation, also decreased, from 3.5 to 2.6% (OR, 0.71; 95% CI, 0.54-0.92). There was a significant decrease in the prescription of benzodiazepines (OR, 0.79; 95% CI, 0.71-0.87), increase in the level of independence in activities of daily living at discharge (OR, 1.94; 95% CI, 1.11-3.38), and decrease in the length of stay (risk ratio 0.90; 95% CI, 0.90-0.90). CONCLUSIONS: The systematic management program for delirium decreased the incidence of delirium and improved several clinical outcomes. These data suggest that this simple cost-effective program is feasible and implementable as routine care in busy wards.