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Purpose Radiation dermatitis is one of the most common acute toxicities induced by chemoradiation therapy (CRT) for head and neck cancer (HNC). The benefit of topical steroids in the management of radiation dermatitis is still unclear. This phase 3, multi-institutional, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of topical steroids for radiation dermatitis in patients with locally advanced HNC receiving CRT. Methods and Materials Eligible patients were scheduled to receive bilateral neck irradiation (≥66 Gy) with concurrent cisplatin (≥200 mg/m2) as definitive or postoperative CRT. Patients were randomly assigned to receive either topical steroid or placebo when grade 1radiation dermatitis was observed or the total radiation dose reached 30 Gy. Basic skin care including gentle washing and moistening in the head and neck region was performed in both groups. The primary endpoint was the frequency of grade ≥2 radiation dermatitis, in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0. Grading of radiation dermatitis was performed by independent central review using photographs taken weekly. Results A total of 211 patients were enrolled (intention to treat: steroid 101 and placebo 102). The frequency of grade ≥2 radiation dermatitis was not significantly reduced with the steroid (73.3%; 95% confidence interval, 64.6%-81.9%) compared with the placebo (80.4%; 95% confidence interval, 72.7%-88.1%; P = .23), whereas the steroid significantly reduced the frequency of grade ≥3 radiation dermatitis (13.9% vs 25.5%; P = .034). No significant differences in adverse events, including local infection or compliance with CRT, were observed between the groups. Conclusions Topical steroid may reduce the severity of radiation dermatitis in patients with HNC and thus may become an important therapeutic tool in the management of radiation dermatitis.

Background While several small groups in Japan have attempted to conduct prospective studies in the field of supportive and palliative care, development of exploratory research into multicentre confirmatory studies has been difficult. The main reason for this is the difference in clinical research methodology in supportive and palliative care compared with medical oncology in terms of the style of multidisciplinary approaches, study design and endpoints. Here, we establish a new research policy for cancer supportive and palliative care in Japan. Methods The first draft was developed by a policy working group within the Japanese Supportive, Palliative and Psychosocial Care Study Group. A provisional draft was subsequently developed after review by nine Japanese scientific societies (Japanese Association of Supportive Care in Cancer, Japanese Society of Medical Oncology, Japanese Society of Clinical Oncology, Japanese Society of Palliative Medicine, Japanese Society of Cancer Nursing, Japanese Society of Pharmaceutical Oncology (JASPO), Japan Cancer Association (JCA), Japanese Society of Therapeutic Radiation Oncology and Japanese Cancer Association) and receipt of public comments. The final research policy in the area of supportive and palliative care in Japan (Ver1.0) was completed in December 2018 and underwent its first revision (Ver1.1) in February, 2020. Results The policy includes the following components of clinical research: (i) objective of the research policy in the areas of supportive and palliative care; (ii) definitions of supportive care and palliative care; (iii) characteristics of supportive and palliative care research; (iv) target population for research; (v) research design; (vi) endpoints and assessment measures; (vii) handling of the deaths of subjects and (viii) operational structure and quality management. Conclusions We hope that studies conducted according to this policy will play important roles in the future development of the supportive and palliative field., A new research policy for supportive and palliative care was established. Studies conducted according to this policy will play important roles in the future development of these fields.

Objective To conduct the first national population-based study in Japan to characterize risks of death by suicide, other externally caused injuries and cardiovascular diseases within 6 months of cancer diagnosis. Methods Cancer patients diagnosed between 1 January and 30 June 2016 and registered in the National Cancer Registry in Japan were followed up until death or 6 months after diagnosis. We calculated standardized mortality ratios and excess absolute risks per 10 000 person-years for death by suicide, other externally caused injuries and cardiovascular diseases compared with the Japanese general population. Results Of 546 148 patients with cancer (249 116 person-years at risk), we observed 145 suicides, 298 deaths due to other externally caused injuries and 2366 cardiovascular deaths during the follow-up period. Standardized mortality ratios within 6 months were 2.68 for suicide (95% confidence interval, 2.26–3.16; excess absolute risk, 3.65), 1.49 for other externally caused injuries (95% confidence interval, 1.32–1.67; excess absolute risk, 3.92) and 1.38 for cardiovascular diseases (95% confidence interval, 1.33–1.44; excess absolute risk, 26.85). Risks were highest during the first month after cancer diagnosis (standardized mortality ratios: suicide, 4.06 [95% confidence interval, 2.90–5.53]; other externally caused injuries, 2.66 [95% confidence interval, 2.17–3.12] and cardiovascular diseases, 2.34 [95% confidence interval, 2.18–2.51]). Conclusions The first 6 months, and especially the first month, after cancer diagnosis were found to be a critical period for risks of death by suicide, other externally caused injuries and cardiovascular diseases. Our findings suggest that oncologists need to evaluate suicidal and cardiovascular risks of patients immediately after cancer diagnosis and provide preventive interventions.

Background The Japanese Psycho-Oncology Society and Japanese Association of Supportive Care in Cancer recently launched the clinical practice guidelines for delirium in adult cancer patients. The aim of the guidelines was to provide evidence-based recommendations for the clinical assessment and management of delirium in cancer patients. This article reports the process of developing the guideline 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 multidisciplinary members, formulated nine clinical questions. A systematic literature search was conducted to identify relevant articles published prior to through 31 May 2016. Each article was reviewed by two independent reviewers. The level 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 recommendation statements. Results This article provides a summary of the recommendations with rationales for each, as well as a short summary. Conclusions These guidelines will support the clinical assessment and management of delirium in cancer patients. However, additional clinical studies are warranted to further improve the management of delirium., The Japanese Psycho-Oncology Society and Japanese Association of Supportive Care in Cancer launched the guidelines for delirium. This article reports the process of developing the guideline and summarizes the recommendations.

Summary Background Olanzapine 10 mg added to standard antiemetic therapy including aprepitant, palonosetron, and dexamethasone has been recommended for the prevention of chemotherapy-induced nausea and vomiting. Guidelines suggest that a dose reduction to 5 mg should be considered to prevent sedation. In several phase 2 studies, olanzapine 5 mg has shown equivalent activity to olanzapine 10 mg and a favourable safety profile in relation to somnolence. We evaluated the efficacy of olanzapine 5 mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting caused by cisplatin-based chemotherapy. Methods This was a randomised, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy of olanzapine 5 mg with triplet-combination antiemetic therapy done in 26 hospitals in Japan. Key inclusion criteria were patients with a malignant tumour (excluding those with a haemopoietic malignancy) who were scheduled to be treated with cisplatin (≥50 mg/m2) for the first time, age between 20 and 75 years, and with Eastern Cooperative Oncology Group performance status of 0–2. Eligible patients were randomly assigned (1:1) to receive either oral olanzapine 5 mg or placebo once daily on days 1–4 combined with aprepitant, palonosetron, and dexamethasone (dosage based on the standard antiemetic therapy against highly emetogenic chemotherapy). Patients were randomly assigned to interventions by use of a web entry system and the minimisation method with a random component, with sex, dose of cisplatin, and age as factors of allocation adjustment. Patients, medical staff, investigators, and individuals handling data were all masked to treatment assignment. The primary endpoint was the proportion of patients who achieved a complete response, defined as absence of vomiting and no use of rescue medications in the delayed phase (24–120 h). All randomly assigned patients who satisfied eligibility criteria received a dose of cisplatin 50 mg/m2 or more, and at least one study treatment, were included in efficacy analysis. All patients who received any treatment in this study were assessed for safety. This study is registered at UMIN Clinical Trials Registry, number UMIN000024676. Findings Between Feb 9, 2017, and July 13, 2018, 710 patients were enrolled; 356 were randomly assigned to receive olanzapine and 354 were assigned to receive placebo. All eligible patients were observed 120 h after cisplatin initiation. One patient in the olanzapine group and three in the placebo group did not receive treatment and were excluded from all analyses. One patient in the olanzapine group discontinued treatment on day 1 and was excluded from the efficacy analysis. In the delayed phase, the proportion of patients who achieved a complete response was 280 (79% [95% CI 75–83] of 354 patients in the olanzapine group and 231 (66% [61–71] of 351 patients in the placebo group (p Interpretation Olanzapine 5 mg combined with aprepitant, palonosetron, and dexamethasone could be a new standard antiemetic therapy for patients undergoing cisplatin-based chemotherapy. Funding Japan Agency for Medical Research and Development.

Background There is an immense difference between large companies and small and medium-sized enterprises (SMEs) in implementation of evidence-based interventions (EBIs). Previous literature reveals various barriers that SMEs face during implementation, such as a lack of time, accessibility, and resources. However, few studies have comprehensively examined those influential factors at multi-levels. This study aims to identify the factors influencing the implementation of non-communicable disease prevention activities (tobacco, alcohol, diet, physical activity, and health check-up) in SMEs using Consolidated Framework for Implementation Research (CFIR). Methods We conducted 15 semi-structured interviews with health managers and/or employers in 15 enterprises with less than 300 employees, and four focus groups among public health nurses/nutritionists of health insurers who support SMEs in four prefectures across Japan. A qualitative content analysis by a deductive directed approach was performed. After coding the interview transcript text into the CFIR framework constructs by two independent researchers, the coding results were compared and revised in each enterprise until an agreement was reached. Results Of the 39 CFIR constructs, 25 were facilitative and 7 were inhibitory for workplace health promotion implementation in SMEs, which were across individual, internal, and external levels. In particular, the leadership engagement of employers in implementing the workplace health promotion activities was identified as a fundamental factor which may influence other facilitators, including “access to knowledge and information,” “relative priority,” “learning climate,” at organizational level, and “self-efficacy” at the health manager level. The main barrier was the beliefs held by the employer/manager that “health management is one’s own responsibility.” Conclusions Multi-level factors influencing the implementation of non-communicable diseases prevention activities in SMEs were identified. In resource-poor settings, strong endorsement and support, and positive feedback from employers would be important for health managers and employees to be highly motivated and promote or participate in health promotion. Future studies are needed to develop context-specific strategies based on identified barriers and facilitative factors, and empirically evaluate them, which would contribute to narrowing the differences in worksite health promotion implementation by company size.

Background We performed a follow up study about willingness and behaviors to quit smoking among smokers with schizophrenia in Japan. Methods Participants were outpatients with schizophrenia aged 20–69 years who had been visiting the hospital for ≥1 year as of April 1, 2016, and had visited the hospital more than once in the previous 6 months. A baseline survey on smoking behaviors including current smoking status and smoking cessation stage, was administered in 420 participants that were randomly extracted from a patient pool (n = 680) in 2016, and a follow-up survey was administered in 2017. We calculated the distribution and change in smoking cessation stage, number of smokers and nonsmokers after 1 year, and quitting rate from a naturalistic 1-year smoking-cessation follow up. Results The number of baseline respondents was 350; 113 current smokers and 68 former smokers. Among the 113 current smokers, 104 (92.0%) were followed for 1 year, 79 (70.0%) were interested in smoking cessation, and only 7 had received smoking cessation treatments at baseline. Among the tracked 104 participants, only 6 (5.8%) stopped smoking after 1 year. Among the 25 participants who had intentions to quit smoking within 6 months at baseline, 6 (24.0%) maintained their intention to quit smoking for 1 year, and 16 (64.0%) did not maintain their intention to quit smoking. Conclusions Our findings showed that many smokers with schizophrenia were interested in quitting smoking, but few patients received treatment and actually quit smoking. Timely intervention, including the option to receive smoking cessation treatment, is necessary for those patients with schizophrenia who smoke. Trial registration UMIN Clinical Trials Registry (UMIN000023874, registered on August 31, 2016).

Context When discussing end-of-life issues with cancer patients, the addition of reassurance statements is considered helpful. However, patients' preferences for such statements have not been systematically demonstrated. Objectives The objectives of this study were to clarify if phrases with additional reassurance statements would be more preferable to phrases without them and explore variables associated with patients' preferences. Methods In a cross-sectional survey, 412 cancer patients assessed their own preferences for phrases with/without additional statements using a six-point scale (1 = not at all preferable; 6 = very preferable). These included the statements of “hope for the best and prepare for the worst” (“hope/prepare”) when discussing prognosis; symptom palliation when discussing code status; and specific goals, continuity of care, and nonabandonment when discussing hospice referral. We evaluated demographic data and the coping style and conducted multivariate regression analysis. Results Compared with the phrase of life expectancy (i.e., median + typical range) alone [mean (SD), 3.5 (1.2); 95% CI, 3.4–3.6], the phrase with the additional “hope/prepare” statement was more preferable [3.8 (1.4); 3.7–3.9]. Compared with the phrase of do-not-resuscitate alone (3.1(1.3); 3.0–3.3), the phrase with the additional statement of symptom palliation was more preferable [3.9 (1.3); 3.7–4.0]. Compared with the phrase of hospice referral alone [3.4 (1.2); 3.3–3.5], phrases with the addition of a specific goal [3.9 (1.0); 3.8–4.0], specific goal and continuity (4.4(1.0); 4.3–4.5), and specific goal, continuity, and nonabandonment [4.8 (1.2); 4.7–4.9] were more preferable. In multivariate analyses, task-oriented coping was significantly correlated with preferences for phrases including additional reassurance statements. Conclusion Cancer patients systematically preferred reassurance statements. In end-of-life discussions, especially with patients with task-oriented coping, clinicians may provide additional reassurance statements.

Background Optimal cancer survivorship care needs its comprehensive guidelines. We aimed to identify English and Japanese guidelines that include cancer survivorship in their title, the issues highlighted in such guidelines, and any existing oncology practice guidelines in Japan that address these issues. Methods This literature review was performed in three stages. First, guidelines published in English or Japanese that included cancer survivorship in the title were identified. Then, the issues that each cancer survivorship guideline addressed were defined. Lastly, Japanese guidelines that include survivorship issues were sought. Results Six guidelines published in English addressed 31 cancer survivorship issues. No specific cancer survivorship guideline was available in Japanese. Thirty-four Japanese guidelines mentioned cancer survivorship issues. These guidelines addressed screening/surveillance for detecting recurrence or secondary cancer but did not address coordination of care, implications for practice, or inclusion of family. At present, Japanese guidelines poorly address the issue of promotion of a healthy lifestyle in cancer survivors. Also, poorly addressed were long-term and late effects such as pain, psychological distress, fatigue, cognitive dysfunction, cardiovascular effects (including anthracycline-induced cardiac toxicity), sleep disorders, and sexual dysfunction in cancer survivors. Conclusion There is a need for guidelines on optimal coordination of care between oncologists and other health care providers to support patients along the cancer care continuum and specifically to encourage a healthy lifestyle as part of cancer survivorship. The development of a comprehensive Japanese guideline that addresses these issues would help to improve the clinical outcome for cancer survivors in Japan.

Introduction Although various phrases to communicate prognoses based on a certain concept have been proposed, no study has systematically investigated preferences of patients with cancer for actual phrases. We investigated whether phrases with a wider range and additional “hope for the best, and prepare for the worst” (hope/prepare) statement would be more preferable and explored variables associated with patients’ preferences. Materials and Methods In a cross-sectional survey, 412 outpatients with cancer self-assessed their preferences for 13 phrases conveying prognostic information (e.g., phrases with or without median, typical range, and/or best/worst cases, and those with or without a hope/prepare statement) on a 6-point scale (1 = not at all preferable; 6 = very preferable). We evaluated demographic data and the Coping Inventory for Stressful Situations and conducted multivariate regression analysis. Results Regarding phrases with various ranges, the one including the median, typical range, and best/worst cases was more preferable (mean ± SD, 3.8 ± 1.3; 95% confidence interval [CI], 3.6–3.9) than the one with the median and typical range (3.4 ± 1.2; 3.3–3.6) or the one with only the median (3.2 ± 1.3; 3.1–3.3). Concerning the hope/prepare statement, the phrase including the median, typical range, uncertainty, and hope/prepare statement was more preferable (3.8 ± 1.4; 3.7–3.9) than the one without the statement (3.5 ± 1.2; 3.4–3.6). In multivariate analyses, task-oriented coping was significantly correlated with preferences for phrases with explicit information. Conclusion Overall, phrases with a wider range and the hope/prepare statement were preferable to those without them. When patients with cancer ask about prognoses, especially those with task-oriented coping, clinicians may provide explicit information with a wider range and the hope/prepare statement. Implications for Practice Discussing prognoses with patients with advanced cancer is among the most important conversations for clinicians. In this cross-sectional survey to systematically investigate preferences of 412 patients with cancer for phrases conveying prognostic information, phrases with the median, typical range, and best/worst cases and those with the “hope for the best and prepare for the worst” (hope/prepare) statement were the most preferred. When patients with cancer ask about prognoses, clinicians may provide explicit information with a wider range and include the hope/prepare statement.

OBJECTIVE We examined the efficacy of a case management approach to improve participation in colorectal cancer screening among people with schizophrenia. METHODS This was a randomized, parallel group trial. We recruited outpatients with schizophrenia aged 40 years or over from two psychiatric hospitals in Japan. Participants were randomly assigned (1:1) to treatment as usual or case management intervention plus treatment as usual using a web-based system. Attending clinicians and participants were unmasked to the allocation. Case management included education and patient navigation for colorectal cancer screening using a fecal occult blood test. Treatment as usual included direct mail government recommendations. The primary endpoint was participation in colorectal cancer screening assessed using municipal records. We also assessed the secondary endpoint of participation in other cancer screenings (lung, gastric, breast, and cervical). RESULTS Between 3 June and 9 September 2019, 172 eligible participants were randomly assigned to the case management plus treatment as usual group (n = 86) or treatment as usual group (n = 86). One participant was ineligible and another withdrew consent; both were excluded from analysis. A significantly higher proportion of participants received colorectal cancer screening in the case management plus treatment as usual group than in the treatment as usual group (40 [47.1%] of 85 participants vs. 10 [11.8%] of 85 participants, p

Background Young adult cancer patients often face unique challenges and have potential unmet needs. This study aimed (1) to describe unmet supportive care needs among young adults with cancer in Japan, and (2) to identify its associated factors. Methods In a cross-sectional web-based survey, 206 young adults with cancer were assessed for supportive care needs. Multiple regression analysis examined whether demographics, clinical variables and social support were associated with unmet supportive care needs. Results A total of 206 patients (180 female) with a mean age of 33.7 years (SD = 4.3, range: 22–39) participated. One hundred and fifty-eight participants (76.7%) reported at least one unmet supportive care needs. The top 20 unmet needs included 9 of the 10 psychological needs, 3 of the 5 physical and daily living needs, 8 of the 11 health system and information needs and 1 of the 5 sexuality needs. Multiple regression analysis revealed that perceived poorer PS, experience of change in work/school after a cancer diagnosis and poor social support were significantly associated with higher supportive care needs. The total score of supportive care needs was significantly associated with both psychological distress and QOL. Conclusions More than 70% of young adult cancer patients reported unmet supportive care needs and most of those were psychological needs. The findings suggest potential opportunities for intervention in addressing psychological needs rather than physical and information needs.

IntroductionAlthough topical use of moisturisers is slightly effective for the prevention and avoiding the aggravation of hand–foot syndrome induced by multikinase inhibitors, there is still room for improvement. Hydrocolloid dressing is a type of wound dressing often used for wounds such as decubitus ulcers. The purpose of this study is to verify the usefulness of application of hydrocolloid dressings as prophylaxis against development of hand–foot syndrome induced by multikinase inhibitors by comparing the effects of this dressing and standard supportive care (moisturising care alone) within the same individuals.MethodsThis study is a phase 3 randomised, self-controlled study to compare prophylactic moisturising care with or without hydrocolloid dressing for hand–foot syndrome induced by multikinase inhibitors. Patients with radically unresectable advanced or recurrent colorectal carcinoma, gastrointestinal stromal tumour and hepatocellular carcinoma who scheduled to receive regorafenib or sorafenib therapy are eligible for enrolment.Supportive care for hand–foot syndrome will consist of basic moisturising care with or without hydrocolloid dressing. If hand–foot syndrome occurs, a steroid ointment will be applied two times per day at the affected sites. The primary endpoint is an incidence rate of grade 2 or more severe hand–foot syndrome (soles of the feet only) assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events V.4.0. Grading of hand–foot syndrome will be performed by central review using photographs taken weekly by blinded trained physicians. The ethical approval was obtained from National Cancer Center Hospital. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conference.DiscussionIf the positive results are found in this study, it is shown that hydrocolloid dressing is effective not only as a symptom management but also as a prevention in hand–foot syndrome induced by multikinase.Trial statusThe enrolment was started in January 2019, and planned to closed in January 2021. As of February 2020, 26 patients enrolled in this study.Trial registration numberUMIN Clinical Trial Registry (UMIN000034853).Protocol versionV.1.4, 9 January 2020.

Dyspnea is a common distressing symptom among patients with advanced cancer.The objective of this study was to determine the effect of fan therapy on dyspnea in patients with terminally ill cancer.This parallel-arm, randomized controlled trial included 40 patients with advanced cancer from a palliative care unit at the National Cancer Center Hospital in Japan. All patients experienced dyspnea at rest with a score of at least three points on a subjective 0- to 10-point Numerical Rating Scale (NRS), showed peripheral oxygen saturation levels of ≥90%, had an Eastern Cooperative Oncology Group grade of 3 or 4, and were aged 20 years or more. In one group, a fan was directed to blow air on the patient's face for five minutes. This group was compared to a control group wherein air was blown to the patient's legs. Patients were randomly assigned to each group. The main outcome measure was the difference in dyspnea NRS scores between fan-to-face and fan-to-legs groups.No significant differences were seen in baseline dyspnea NRS between groups (mean score, 5.3 vs. 5.1, P = 0.665). Mean dyspnea changed by -1.35 points (95% CI, -1.86 to -0.84) in patients assigned to receive fan-to-face and by -0.1 points (-0.53 to 0.33) in patients assigned to receive fan-to-legs (P 0.001). The proportion of patients with a one-point reduction in dyspnea NRS was significantly higher in the fan-to-face arm than in the fan-to-legs arm (80% [n = 16] vs. 25% [n = 5], P = 0.001).Fan-to-face is effective in alleviating dyspnea in patients with terminally ill cancer.

Background Smoking behavior among people with serious psychological distress (SPD) has not been fully investigated in Asia, although smoking has become a public health concern worldwide. Many Western population-based studies indicate that people with psychological distress are more likely to smoke. Methods This study used a national representative data set from the 2010 Comprehensive Survey of Living Conditions of Japan. SPD was defined as scores ≥13 or greater on the Kessler Psychological Distress Scale (K6). Multivariate logistic regression analyses were conducted to analyze the association between SPD and current smoking in Japanese adults. Results In both men (n = 27,937) and women (n = 30,786), SPD was significantly associated with current smoking (adjusted odds ratios [95% confidence intervals]: 1.169 [1.030–1.328] for men and 1.677 [1.457–1.931] for women). Among men, SPD was significantly associated with current smoking only in people aged ≥50 years (1.519 [1.232–1.874]) and married (1.456 [1.228–1.728]). SPD was significantly associated with current smoking in women of all ages. SPD had a greater impact on current smoking for women aged 20–49 years than for those aged ≥50 years (1.832 [1.552–2.162] and 1.445 [1.099–1.900], respectively). Limitations The cross-sectional design precludes assumptions about the direction of causality. In addition, smoking status was self-reported. Conclusions SPD was significantly associated with current smoking in Japan and the association was much stronger for younger women. Clinical strategies are needed to reduce the prevalence of smoking among people with SPD to reduce excess mortality in this population.

Postoperative delirium is a common and important complication in cancer patients. We need to identify patients at high risk of postoperative delirium such that it can be prevented preoperatively or in early postoperative phase. The aim of this study was to investigate whether preoperative anxiety predicted onset of postoperative delirium in cancer patients, not only in order to identify high-risk groups but also to help develop new preventive approaches. This was a prospective observational cohort study of cancer patients undergoing tumor resections. Postoperative delirium was assessed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). Preoperative anxiety was evaluated with the Hospital Anxiety and Depression Scale-Anxiety (HADS-A), and we defined HADS-A > 7 as clinical anxiety. We conducted multivariate logistic regression to determine which factors were predictors of delirium. The final analysis included 91 patients, 29 of whom met the criteria for postoperative delirium. In multivariable logistic regression, age (5-year increments; odds ratio (OR) = 1.565, 95% confidence interval (CI) = 1.057–2.317, p = 0.025) and HADS-A > 7 (OR = 4.370, 95% CI = 1.051–18.178, p = 0.043) predicted delirium onset. These variables explained 74.2% of the variance. Preoperative anxiety strongly predicted postoperative delirium in cancer patients. Our findings suggest that preoperative anxiety may be a new target for prevention of postoperative delirium. Trial registration number This study was registered at UMIN000018980

Context. The importance of communication between the cancer bereaved and others has been emphasized, but little is known about the more problematic aspects of this communication such as ‘‘unhelpful communication.’’ Objectives. The aim of this study was to establish which types of communication are perceived by the bereaved to be unhelpful. Methods. We conducted a cross-sectional, anonymous, nationwide survey at 103 certified hospice facilities/palliative care units in Japan. Results. A total of 630 (63%) bereaved responded. Over 60% of the bereaved experiencing such communication considered it to be unhelpful, with the most unhelpful communication being ‘‘They emphasized the positive aspects of death.’’ Thirteen items related to communication were separated into two factors (‘‘advice for recovery’’ and ‘‘comments on cancer’’) by factor analysis. ‘‘Comments on cancer’’ were more unhelpful to them and were more often provided by those around them. With regard to ‘‘advice for recovery,’’ losing a spouse was a stronger predictor with a higher odds ratio for communication distress than losing a parent (odds ratio, 5.34; 95% CI, 1.63-17.57). Conclusion. A number of the bereaved have experienced unhelpful communication regarding advice on dealing with bereavement and cancer. To prevent putting an unnecessary burden on the bereaved with such unhelpful communication, it is essential to understand problematic aspects. Even when people have no intention of hurting the bereaved, some communication may do so. Communication with the bereaved is also a core clinical skill required by health professionals, and further efforts are required to support the grieving process.

BACKGROUND It is unclear whether individuals who have serious psychological distress (SPD) are less likely to participate in screening tests for gastric cancer, lung cancer, and other types of cancer. Of the few studies that have examined the association between SPD and participation in cancer screening, none have reported modifying effects of educational, marital, or employment status. METHODS The authors analyzed a national representative data set from the 2010 Comprehensive Survey of Living Conditions of Japan., including individuals aged

IntroductionOne of the reasons for the high mortality rate from cancer in people with schizophrenia is delay in diagnosis. Many studies have shown lower cancer screening rates in people with schizophrenia; however, there are no interventions for people with schizophrenia to increase cancer screening. Therefore, we developed a case management (CM) intervention to encourage participation in cancer screening. The purpose of this study was to examine the efficacy of CM to encourage participation in cancer screening for people with schizophrenia, with particular focus on colorectal cancer screening by faecal occult blood testing, compared with usual intervention (UI), namely, municipal public education.Methods and analysisThis is an individually randomised, parallel group trial with blinded outcome assessments. The participants will be randomly allocated to either the CM plus UI group or UI alone group in a 1:1 ratio using a web-based program at a data management centre. The primary end point of the study is participation in colorectal cancer screening in the year of intervention, which will be assessed based on municipal records.Ethics and disseminationThis study is performed in accordance with Ethical Guidelines for Medical and Health Research Involving Human Subjects published by Japan’s Ministry of Education, Science, and Technology and the Ministry of Health, Labour, and Welfare and the modified Act on the Protection of Personal Information as well as the Declaration of Helsinki. This study was approved by the institutional ethics committee at the Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences and Okayama University Hospital on 23 April 2019 (approval number: RIN1904-003). The findings of this trial will be submitted to an international peer-reviewed journal.Trial registration numberUMIN000036017.

To develop consensus-based components used in the first evidence-based cancer survivorship guidelines in Japan. Purposive sampling was used to recruit a panel of experts in oncology clinical practice, nursing, health science, epidemiology, and patient advocacy. The panel engaged in a modified Delphi process to (1) generate consensus related to the definition of survivorship, (2) determine the aim and target users of the guideline, and (3) identify clinical issues for inclusion. A Web-based survey and panel meeting were conducted to obtain the panelists’ feedback on the initial draft proposed by the secretariat. Multiple online votes were then completed until all elements of the proposed guidelines reached an approval rate of 80% or higher. Following each round, iterative refinements were made based on all panelists’ feedback. Twenty-two experts were enrolled in the panel and participated in four rounds of online voting and two face-to-face meetings. Ultimately, the panel reached consensus on the definition of survivorship, the aim of the guidelines, and target users. Moreover, 11 of the original 17 clinical issues were retained. Finally, the panel selected two priority areas to implement immediately. The panel’s consensus on the definition of survivorship, aim and target users of the guideline, and 11 clinical issues will serve as a compass for the development of comprehensive cancer survivorship guidelines in Japan. A culturally sensitive consensus approach was developed to improve the long term health and well- being of cancer survivors in Japan.

Background:In medical practice, a patient’s loss of competency is a major obstacle when choosing a treatment and a starting treatment program smoothly. A large number of studies have revealed the lack of medical competency in patients with dementia. However, there have been only a few reports focusing on the capacity of patients with mild cognitive impairment (MCI) to make a medical choice.Methods:In this study, we evaluated the competency of 40 patients with amnestic MCI (aMCI) and 33 normal subjects to make a medical choice using the MacArthur Competence Assessment Tool-Treatment (MacCAT-T). We compared the judgement of a team conference using the recorded semi-structured interview with the clinical judgement of a chief clinician.Results:A team conference concluded that 12 aMCI patients had no competency, and the clinical judgement, without any special interview, judged that five aMCI patients had no competency. All subjects in the control groups were judged to be competent to consent to treatment by both clinicians and the team conference.Conclusions:Without supplementary tools such as explanatory documents, not a few patients with aMCI were judged by a team conference to have no competency to consent to therapy even in a relatively simple and easy case. In contrast, clinical physicians tended to evaluate the competency of aMCI patients in a generous manner.

BACKGROUND Nondisclosure of a poor prognosis to patients with advanced cancer remains a typical practice in Asia. Although the importance of prognostic communication has increasingly been recognized worldwide, little is known about whether explicit prognostic disclosure positively affects Asian patients with advanced cancer. The objective of this study was to examine the effects of explicit prognostic communication on patients with cancer recurrence. METHODS In this randomized, video-vignette study, Japanese women with breast cancer who had undergone curative surgery viewed videos of prognostic communication between a patient with recurrent, incurable breast cancer and her oncologist. The videos differed only in the presence or absence of explicit prognostic disclosure. The primary outcome was participants' uncertainty (rated from 0 to 10), and the secondary outcomes included anxiety (measured on the State-Trait Anxiety Inventory-State: range, 20-80), satisfaction (Patient Satisfaction Questionnaire; range 0-10), self-efficacy (range, 0-10), and willingness to discuss advance care planning (range, 1-4). RESULTS In total, 105 women participated (mean ± SD age, 53.8 ± 8.2 years). After viewing the video with more versus less explicit disclosure, participants showed significantly lower uncertainty (mean ± SE scores, 5.3 ±0.2 vs 5.7 ± 0.2, respectively; P = .032) and higher satisfaction (5.6 ± 0.2 vs 5.2 ± 0.2, respectively; P = .010) without increasing anxiety (changes in scores on the State-Trait Anxiety Inventory-State: 0.06 ± 0.5 vs 0.6 ± 0.5, respectively; P = .198). No significant differences were observed in self-efficacy (5.2 ± 0.2 vs 5.0 ± 0.2, respectively; P = .277) or willingness to discuss advance care planning (2.7 ± 0.1 vs 2.7 ± 0.1, respectively; P = .240). CONCLUSIONS Explicit prognostic disclosure prompted better outcomes than nondisclosure in Japanese women with breast cancer. When asked about the prognosis by Asian patients with cancer, clinicians may be encouraged to respect their wishes and explicitly discuss the prognosis if deemed appropriate.

Background: Olanzapine 10 mg added to standard antiemetic therapy, including aprepitant, palonosetron, and dexamethasone, has been recommended for the prevention of chemotherapy-induced nausea and vomiting. Guidelines suggest that a dose reduction to 5 mg may be considered to prevent sedation. In several phase II studies, olanzapine 5 mg has shown equivalent activity and a favourable safety profile in relation to somnolence. We conducted a randomised, double-blinded, placebo-controlled, phase III study (J-FORCE) to evaluate olanzapine 5 mg combined with standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting caused by cisplatin-based chemotherapy. Methods: This was a multicentre, phase III study to evaluate olanzapine 5 mg with triplet-combination therapy. Patients receiving cisplatin ((≥50 mg/m2) were randomly assigned to receive oral olanzapine 5 mg or placebo once daily on days 1-4 combined with aprepitant, palonosetron, and dexamethasone (dosage based on the standard antiemetic therapy against highly emetogenic chemotherapy). The primary endpoint was the proportion of complete response (CR), defined as absence of vomiting and no use of rescue medications in the delayed phase (24-120 hours). Findings: Between February 9, 2017 and July 13, 2018, 710 patients were enrolled from 26 hospitals in Japan. Of those, 356 and 354 patients were randomly assigned to the olanzapine and placebo groups, respectively. In the delayed phase, CR was 79% (95% CI: 75-83) in the olanzapine 5 mg group and 66% (95% CI: 61-71)a€€in the placebo group (p

12012 Background: Geriatric assessment (GA) is recommended in various guidelines for older adults with cancer, but is not widely used in daily practice. This study aims to identify multi-level barriers and facilitators of GA implementation in daily oncology practice, based on a theoretical implementation framework. Methods: We conducted 20 semi-structured interviews with healthcare providers and managers in 14 hospitals treating older adults with cancer in Japan. The Consolidated Framework for Implementation Research (CFIR) was used to guide the collection and analysis of interview data using a deductive approach. CFIR consists of 5 major domains (I. intervention characteristics, II. outer setting, inner setting,. individual characteristics, and V. process), including 39 constructs. Differences in the constructs influencing GA implementation between hospitals where GA is routinely performed (high implementation, HI) and hospitals where GA is not performed or performed only in clinical trials (low implementation, LI) were explored. Results: Among constructs identified as barriers or facilitators of GA implementation, 15 multi-level constructs greatly differed between 5HI and 5LI, including 4 constructs from intervention characteristics, 6 from inner setting, 1 from individual characteristics, and 4 from process. In HI, GA was self-administered (I. adaptability), or administered on a mobile app with interpretation (I. design quality and packaging). In HI, healthcare providers strongly perceived the need to change the practice for older adults (III. tension for change), and recognized GA as fitting in with existing workflow as part of their jobs (III. compatibility). In LI, they did not realize the need to change practice, and rejected GA as an extra burden on their heavy workload. In HI, the usefulness of GA was widely recognized by healthcare providers (IV. knowledge and beliefs about the intervention), GA was given high priority (III. relative priority), had strong support from hospital directors and nursing chiefs (V. leadership engagement), and multiple stakeholders were successfully engaged, such as healthcare providers, especially nurses (V. key stakeholders), directors and nursing chiefs (V. opinion leaders), and those who dedicated themselves to implementing GA (champions). Conclusions: This is the first study to reveal the multi-level barriers and facilitators of GA implementation in daily oncology practice. The findings highlight the need to focus not only on individual or intervention characteristics, but also on the inner setting and the process of implementing GA. Our findings suggest future strategies, such as devising the administration of GA using technology, conducting local needs assessment and consensus discussions about the usefulness and priority of GA, and engaging multiple stakeholders.

12097 Background: The integration of palliative care into standard cancer treatment during the early phase of the disease can improve cancer patients’ quality of life (QOL). The current study examined the effectiveness of a nurse-led, screening-triggered, early specialized palliative care intervention program for patients (pts) with advanced lung cancer. Methods: Pts with advanced lung cancer undergoing initial chemotherapy were randomized (1:1) to the intervention group (IG) or the usual care group (UG) between January 2017 and September 2019. The intervention, which was triggered using by a brief, self-administered screening tool, comprised comprehensive need assessments, counseling, and service coordination by advanced-leveled nurses. The primary endpoint was the change from baseline of the Functional Assessment of Cancer Therapy -Lung Trial Outcome Index (TOI) at week 12, and the secondary endpoints were TOI at week 20, depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), and survival. Results: Pts were randomly allocated (102 for each group). The median age was 69 y (range, 27-91) and 77.5% were male. Seventy-two pts had extensive disease small-cell lung carcinoma and 132 Pts had stage IV non-small cell lung carcinoma. Because there was not a significant time-by-group interaction, we estimated main effects and the IG did not show a significant improvement in TOI from the baseline at week 12 and 20 compared to the UG (Mean group difference [the same applies hereafter] 2.13; 90% CI: -0.70, 4.95; P =.107, one-tailed). However, when we considered time-by-group interaction effects exploratorily, the IG did show significant improvement in TOI from baseline at week 20 compared to the UG (3.58; 90% CI: 0.15, 7.00; P = 0.043). There was no significant difference in change from baseline depression and anxiety between the two groups either at week 12 (depression −0.38; 95% CI: -1.81, 1.05; P = 0.60, anxiety -0.18; 95% CI: -1.45, 1.09; P = 0.78) or at week 20 (depression -1.27; 95% CI: -2.79, 0.25; P =.10, 1.26; 95% CI: -2.61, 0.09; P =.067). The 1-year survival rates were 49.5% (95% CI: 39.3, 58.9) in the IG and 43.4% (95% CI: 33.6, 52.8) in the UG. Conclusions: This trial failed to show statistical superiority of nurse-led, screening-triggered, early specialized palliative care intervention program over usual care, however, it’s possible delayed clinical benefits of improvement in QOL (TOI), depression and anxiety were suggested. The study design that some pts in the IG received later or no intervention, may dilute the difference of intervention between group differences. Further investigation, including the mixed method approach adopted in this study, is needed to uncover mediating factors for the effect of this low-cost, novel model of early palliative care. Clinical trial information: UMIN000025491.

Objective Guidelines for supportive care in cancer patients have recommended routine psychological screening in clinical practice, and a Japanese national project has recommended screening for depression using the Distress and Impact Thermometer. However, a previous study advocating the validity of the Distress and Impact Thermometer may have overestimated its effectiveness, as the study included already-treated patients who were not screening targets. This study re-evaluated the performance and usefulness of the Distress and Impact Thermometer using an adequate sample size and appropriate study design. Methods Patients were consecutively recruited at two highly specialized hospitals and three university hospitals in Japan. Inclusion criteria were (i) undergoing aggressive anti-cancer treatment, (ii) the Eastern Cooperative Oncology Group performance status score 20 years. Patients who were receiving psychiatric treatment were excluded from the study. After completing the Distress and Impact Thermometer, patients were evaluated with the gold-standard Composite International Diagnostic Interview by researchers who were blinded to the patients' Distress and Impact Thermometer scores. Results Forty-four patients (9%) who were receiving psychiatric treatment were excluded. Of 468 subjects included in the final analysis, only 3 had current depression (0.6%). Using cutoff points recommended by the previous study, the positive and negative predictive values were 0.02 and 0.99, respectively. Conclusions Our data indicated that screening for untreated depression in cancer patients was not useful in the specific clinical settings that were studied, and such screening should be implemented in appropriate contexts. Since there are no evidence-based recommendations regarding contexts in which psychological screening is essential, further research is needed.

Many patients with schizophrenia have poor clinical and social outcomes. Some risk alleles closely related to the onset of schizophrenia have been reported to be associated with their clinical phenotypes, but the direct relationship between genetic vulnerability to schizophrenia and clinical/social outcomes of schizophrenia, as evaluated by both practical clinical scales and 'real-world' function, has not been investigated. We evaluated the clinical and social outcomes of 455 Japanese patients with schizophrenia by severity of illness according to the Clinical Global Impression-Severity Scale (CGI-S) and social outcomes by social adjustment/maladjustment at 5 years after the first visit. We examined whether 46 single nucleotide polymorphisms (SNPs) selected from a Japanese genome-wide association study of susceptibility to schizophrenia were associated with clinical and social outcomes. We also investigated the polygenic risk scores of 46 SNPs. Allele-wise association analysis detected three SNPs, including rs2623659 in the CUB and Sushi multiple domains-1 (CSMD1) gene, associated with severity of illness at end point. The severity of illness at end point was associated with treatment response, but not with the severity of illness at baseline. Three SNPs, including rs2294424 in the C6orf105 gene, were associated with social outcomes. Point estimates of odds ratios showed positive relationships between polygenic risk scores and clinical/social outcomes; however, the results were not statistically significant. Because these results are exploratory, we need to replicate them with a larger sample in a future study.

BACKGROUND: Pharmacists are expected to play a key role in modern cancer care. Research suggests that an empathic approach and attitude in medical staff improves the quality of patient care. An empathic attitude and psychological distress are thought to be associated with autistic-like traits, but little is known about such traits. OBJECTIVE: In this study, we aimed to clarify the associations among autistic-like traits, empathic attitude in a medical context, and psychological health in hospital pharmacists. SETTING: Eligibility criteria for inclusion were certified pharmacists working at hospitals for patient care who returned their questionnaires. METHOD: Eight hundred and twenty-three hospital pharmacists completed a number of self-administered questionnaires anonymously by mail. MAIN OUTCOME MEASURES: Scores were obtained on the Autism-Spectrum Quotient, the Jefferson Scale of Empathy, the General Health Questionnaire-12, and subscales of the Interpersonal Reactivity Index (Perspective Taking, IRI-Empathic Concern, IRIPersonal Distress). We performed correlation and mediation analyses to confirm that the empathy and general health questionnaires were associated with autism-spectrum quotient scores, and with each IRI subscale. RESULTS: Complete responses were obtained from 379 pharmacists comprising 151 males (39.8 %) with a mean age of 37.7 ± 10.8 years (missing data, n = 13) and a median of 11 years after qualification as a pharmacist. Autism-Spectrum Quotient scores were inversely correlated with empathy (r = -0.22, p < 0.001) and positively correlated with general health scores (r = 0.40, p < 0.001). In the models with mediation, the inverse correlation between autism-spectrum quotient and empathy scores was mediated indirectly by IRI-Perspective Taking and IRI-Empathic Concern, and the positive correlation between autism-spectrum quotient and general health was mediated indirectly by IRI-Personal Distress. There were also direct effects, with significant effects of autism-spectrum quotient on empathy and general health scores. CONCLUSION: Our findings suggest that autistic-like traits affect both empathic attitude in a medical context and the psychological health of pharmacists. We recommend that to improve empathy in those with high levels of autistic-like traits, we may need to develop specialized interventions, such as improving communication skills training.

IntroductionIt has been suggested that palliative care integrated into standard cancer treatment from the early phase of the disease can improve the quality of life of patients with cancer. In this paper, we present the protocol for a multicentre randomised controlled trial to examine the effectiveness of a nurse-led, screening-triggered, early specialised palliative care intervention programme for patients with advanced lung cancer.Methods and analysisA total of 206 patients will be randomised (1:1) to the intervention group or the control group (usual care). The intervention, triggered with a brief self-administered screening tool, comprises comprehensive need assessments, counselling and service coordination by advanced-level nurses. The primary outcome is the Trial Outcome Index of the Functional Assessment of Cancer Therapy (FACT) at 12 weeks. The secondary outcomes include participants’ quality of life (FACT-Lung), depression (Patient Health Questionnaire-9), anxiety (Generalized Anxiety Disorder-7), illness perception (Prognosis and Treatment Perceptions Questionnaire), medical service use and survival. A mixed-method approach is expected to provide an insight about how this intervention works.Ethics and disseminationThis study has been approved by the Institutional Review Board of the National Cancer Center Japan (approval number: 2016-235). The findings will be disseminated through peer-reviewed publications and conference presentations and will be reflected on to the national healthcare policy.Trial registration numberUMIN000025491.

To determine whether the downward trend in the smoking rate over time in Japan differs between individuals with and without serious psychological distress (SPD), we used nationally representative data sets from the 2007, 2010, 2013, and 2016 Comprehensive Survey of Living Conditions of Japan. SPD was defined as a score ≥ 13 on the six-item Kessler Psychological Distress Scale. We conducted multivariate logistic regression analyses including the interaction terms between SPD and survey year. A total 187,685 participants were included. The interaction terms between SPD and survey year among men were significant for 2010 and 2016 but not for 2013. Among women, the interaction terms between SPD and survey year were not significant for any year. In conclusion, we confirmed that the gap in the rate of smoking between men with SPD and those without SPD decreased from 2007 to 2016. Among women, the gap in the smoking rate between those with SPD and those without SPD remained unchanged. Our findings suggest a need for specific support strategies including pharmacological interventions, especially for women smokers with SPD. Further studies are warranted to identify factors contributing to these sex differences.

Surgery is one of the main treatments component against cancer. Although the basic principle of surgical treatment of cancer is curability, safety, and functionality, early recovery after surgery is also important. While some previous studies focus on physical recovery, there are few studies regarding the perioperative period of cancer patients and their impact on postoperative recovery. This study is aim to clarify psychosocial factors that affect postoperative recovery in cancer patients. The study design is a secondary data analysis of a prospective observational cohort study whose primary purpose was to investigate whether preoperative anxiety predicted onset of postoperative delirium in cancer patients at the National Cancer Center Hospital in Japan. The primary outcome of this study was the length of postoperative hospital stay, and the secondary outcome was postoperative complications. We conducted multivariable regression analysis to determine psychosocial predictors of primary and secondary outcomes. The final analysis included 109 patients. The mean length of postoperative hospital stay was 23.4 (SD = 12.4) days and the incidence rate of postoperative complications was 32.1%. In multivariable regression, preoperative anxiety was positively associated with the length of postoperative hospital stay, while sex (female) and alcohol dependence showed a negative association. Cognitive function was marginally associated with postoperative complications. In conclusion, Appropriate management of preoperative anxiety contributes to early discharge after surgery in cancer patients.

IntroductionOne of the most common distressing conditions experienced by breast cancer survivors is fear of cancer recurrence (FCR). There is, however, no standard intervention for ameliorating FCR. Our clinical experience and previous studies have suggested the potential benefits of problem-solving therapy (PST) and behavioural activation (BA). Given the huge number of cancer survivors and limited number of therapists to competently conduct PST and BA, we have developed PST and BA smartphone applications. This study aimed to evaluate the efficacy of the smartphone-based PST (Kaiketsu-App) and BA (Genki-App) apps in reducing FCR in patients with breast cancer.Methods and analysisThe SMartphone Intervention to LEssen fear of cancer recurrence project is an open-label, individually randomised, parallel-group trial. Allocation will be managed by a central server using a computer-generated random allocation sequence provided by an independent data centre. Participants will be randomised to smartphone-based intervention plus treatment as usual (TAU) or waitlist control with TAU alone. The primary endpoint of the study is the Japanese version of the Concerns About Recurrence Scale, which will be administered as an electronic patient-reported outcome on the patients’ smartphone after 8 weeks.Ethics and disseminationThe present study is subject to the ethical guidelines for clinical studies published by Japan’s Ministry of Education, Science and Technology and Ministry of Health, Labour and Welfare and the modified Act on the Protection of Personal Information as well as the ethical principles established for research on humans stipulated in the Declaration of Helsinki and further amendments thereto. The protocol was approved by the Institutional Review Board of Nagoya City University on 15 January 2018 (ID: 60-00-1171).Trial statusThe randomised trial, which commenced on 2 April 2018, currently enrols participants. The estimated end date for this study is in March 2020.Trial registration numberUMIN000031140; Pre-results.

Background To date, the clinical benefit of topical steroid use has only been demonstrated for radiation dermatitis induced by 50–60 Gy irradiation in breast cancer. However, these agents are also often used clinically for the control of radiation dermatitis induced by high-dose (>60Gy) irradiation with chemotherapy in head and neck cancer. Despite this, the prophylactic efficacy of topical steroids for radiation dermatitis induced by high-dose irradiation is still unclear. The aim of this study is to clarify the benefit of topical steroids in basic nursing care for radiation dermatitis induced by chemoradiotherapy in patients with head and neck cancer. Methods The study is being conducted as a multicenter 2-arm randomized double-blinded placebo-controlled Phase 3 trial in Japan. The study was started in May 2017, with participant enrollment between May 2017 and April 2019. Patients scheduled to receive definitive or postoperative chemoradiotherapy for head and neck cancer are eligible for enrollment. All patients will receive chemoradiotherapy, consisting of single agent CDDP and 70-Gy irradiation. Bilateral neck irradiation is mandatory. Supportive care for radiation dermatitis will consist of basic nursing care with topical steroid or placebo. When radiation dermatitis grade 1 is seen or total radiation dose reaches 30 Gy, minimally required intervention will be started as a first step. If radiation dermatitis worsens to grade 2, the irradiated area will be covered with a moderately absorbent surgical pad and steroid or placebo topical cream. The primary endpoint is a comparison of the proportion of patients with ≥ grade 2 radiation dermatitis by NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. Ethical approval has been obtained from all participating sites. The results of this study will be submitted for publication in international peer-reviewed journals and the key findings will be presented at international scientific conferences. Discussion Evidence supporting the benefit of adding topical steroids in general nursing care for radiation dermatitis induced by high-dose irradiation with chemotherapy is insufficient. This trial aims to clarify the clinical benefit of topical steroid for radiation dermatitis induced by high-dose irradiation with chemotherapy. The trial is ongoing and is currently recruiting. Trial registration number UMIN000027161. Protocol version 3.0, 18 April 2017.

PURPOSE To investigate whether physicians' intrapersonal empathy increased after a communication skills training (CST) workshop. METHOD Participants were oncologists from across Japan with three or more years of clinical experience in oncology. They were recruited through the Internet and via direct contact by the workshop organizers. Participants attended 1 of 132 two-day CST workshops, held between November 2007 and March 2011. Prior to the workshop (baseline/T1), participants completed a survey with demographic questions, the Jefferson Scale of Physician Empathy (JSPE), and the Interpersonal Reactivity Index (IRI). The JSPE was administered again immediately after completion of the workshop (follow-up/T2). Then the JSPE and IRI were administered as part of a three-month follow-up (T3) survey. Changes in participants' mean total JSPE scores, JSPE subscale scores, and IRI subscale scores were compared using multivariate analysis of variance. RESULTS Of the 507 workshop participants who received the three-month follow-up survey, 383 responded (response rate: 75.5%). Total JSPE scores and JSPE subscale scores at T2 and T3 were significantly higher than those at T1 (P < .01). IRI-Perspective Taking and IRI-Empathic Concern subscale scores increased significantly from T1 to T3 (P < .01), whereas IRI-Fantasy and IRI-Personal Distress subscale scores showed no significant changes. The JSPE scores of palliative care physician participants were significantly higher than those of medical oncologist participants at T1 and T3. No signifi cant differences were found by specialty at T2. CONCLUSIONS The intrapersonal empathy of oncologists in Japan increased after a two-day CST workshop.

Background Preoperative anxiety and postoperative delirium affect both short- and long-term prognoses in patients with cancer; therefore, these conditions require early prevention and treatment. However, no standard preventive or therapeutic methods have been established for them. Yokukansan, a Japanese herbal medicine for the treatment of insomnia and anxiety, causes relatively few adverse drug reactions and effectively improves the behavioral and psychological symptoms of dementia. Thus, it is expected to be useful for treating and/or preventing perioperative psychiatric symptoms in patients with cancer. The objective of this study is to clarify the therapeutic effect of Yokukansan for preoperative anxiety and its preventive effect on postoperative delirium in cancer patients, as well as to confirm its safety profile. Methods This study is a randomized, double-blind, placebo-controlled study in cancer patients scheduled to undergo tumor resection. Patients who provide consent are randomly allocated to receive oral administration of Yokukansan or placebo, and study drug administration is continued for 4 days or longer prior to surgery. We defined two primary endpoints, change in preoperative anxiety and incidence of postoperative delirium. Secondary endpoints are severity score of postoperative delirium, duration of postoperative delirium, amount of benzodiazepines used prior to surgery, amount of antipsychotic agents used after surgery, and number of postoperative hospitalization days. We plan to complete the analysis on March 31, 2021. The target number of registered patients is 110 per group, or 220 in total. Discussion This study is the first randomized, double-blind, placebo-controlled study intended to clarify the effects of a Japanese herbal medicine, Yokukansan, in the prevention and treatment of perioperative psychiatric symptoms in patients with cancer. The trial was initiated on August 14, 2017, with 195 subjects randomized by October 5, 2018. Trial registration UMIN Clinical Trials Registry (UMIN-CTR), UMIN000027561. Registered on 31 May 2017. Electronic supplementary material The online version of this article (10.1186/s13063-019-3202-1) contains supplementary material, which is available to authorized users.

Health care disparities among people with schizophrenia is a global concern. Our previous study revealed cancer screening rates in Japanese people with schizophrenia lower than rates of approximately 40% of the general population. However, that study was based on self-reports, which can be inaccurate, and rates did not differentiate the types of cancer screening provider (i.e., municipal screening, collective opportunistic screening, and individual opportunistic screening). This study aimed to investigate records-based cancer screening rates, focusing on participation rates of people with schizophrenia who are subject to municipal cancer screening programs. We conducted a cross-sectional study at a psychiatric hospital outpatient clinic from September to November 2016. We randomly extracted 420 potential participants from among 680 eligible patients and asked them to participate. We then selected subgroups of participants living in Okayama city who were enrolled in the National Health Insurance or Public Assistance systems and were subject to colorectal, gastric, lung, breast, or cervical cancer screening provided by Okayama city (n = 97, 96, 97, 42, and 64, respectively). Participation in cancer screenings was assessed based on local government records. Municipal cancer screening rates were as follows: 13.4% (95% confidence interval: 6.6%-20.2%) for colorectal, 7.3% (2.1%-12.5%) for gastric, 16.5% (9.1%-23.9%) for lung, 21.4% (9.0%-33.8%) for breast, and 14.1% (5.6%-22.6%) for cervical cancers. The findings demonstrated extremely low cancer screening rates among people with schizophrenia subject to municipal cancer screenings in Japan. A strategy to promote municipal cancer screening for people with schizophrenia is needed.

Objective It is known that depression and anxiety occur more frequently in pancreatic cancer patients than in those with other malignancies. However, few studies have assessed depression and anxiety using reliable psychiatric diagnostic tools. The purpose of this study was to determine the prevalence of depression and anxiety among pancreatic cancer patients before and 1 month after the start of anticancer treatment using reliable psychiatric diagnostic tools, and to identify factors that predict their occurrence. Methods Pancreatic cancer patients were consecutively recruited. Structured clinical interviews were used to determine the presence of affective disorders, anxiety disorders and adjustment disorders. Baseline interviews were performed prior to initiation of anticancer treatment, while follow-up interviews were performed 1 month after treatment was started. Medical, demographic and psychosocial backgrounds were also assessed as predictive factors. Results One hundred and ten patients participated in the baseline interview and 91 in the follow-up interview. Depression and anxiety were observed in 15 patients (13.6%) at the baseline, and 15 patients (16.5%) at the follow-up. Lack of confidants was associated with depression and anxiety at the baseline. At the baseline, sadness, lower Karnofsky Performance Status and prior experience with the death of a family member due to cancer predicted newly diagnosed depression and anxiety at the follow-up. Conclusion A considerable percentage of pancreatic cancer patients experienced depression and anxiety. Multidimensional psychosocial predictive factors were found and optimal psychological care should incorporate early detection of sadness.

BACKGROUND The objective of this study was to clarify the communication preferences of patients with advanced cancer regarding discussions about ending anticancer treatment and transitioning to palliative care and to explore the variables associated with those preferences. METHODS Participants were 106 Japanese patients with cancer who had been informed at least 1 week earlier about the cessation of their anticancer treatment. They completed a survey measuring their preferences for communication about ending anticancer treatment and transitioning to palliative care as well as their demographic characteristics. Medical records were also examined to investigate medical characteristics. RESULTS Results of the descriptive analysis indicated that patients strongly preferred their physicians to listen to their distress and concerns (96%), to assure them that their painful symptoms would be controlled (97.1%), and to explain the status of their illness and the physical symptoms that would likely occur in the future (95.1%). Multiple regression analyses identified the factors associated with these preferences: telling patients to prepare mentally and informing them of their expected life expectancy were associated with cancer site; sustaining hope was associated with cancer site and children; and empathic paternalism was associated with duration since cancer diagnosis. CONCLUSIONS The majority of patients preferred their physicians to be realistic about their likely future and wanted to be reassured that their painful symptoms would be controlled. For patients with cancer at certain sites, those with children, and those more recently diagnosed, physicians should communicate carefully and actively by providing information on life expectancy and mental preparation, sustaining hope, and behaving with empathic paternalism. Cancer 2015;121:4240–4249. © 2015 American Cancer Society.

Objective The quality-adjusted life year, which is usually calculated from the health utility value, is now a standard measurement used in political decision-making in health. Although depression is the leading cause of decrement in health utility in general population, impact of comorbid depression among cancer patients has not been studied sufficiently. Therefore, this study aimed to measure the impact of depression on cancer patients' health utility score, according to the severity of depression. Methods Impact of depression severity (measured by the Patient Health Questionnaire) on health utility score (measured by the EuroQoL-5 scale) was evaluated in a sample of 328 Japanese cancer patients, controlling for performance status, symptom burden, and demographic variables. Results The patients with depression had significantly lower health utility value than those without depression (mean decrement = 0.14). Decrements in health utility of 0.13, 0.18, and 0.19 were observed for mild, moderate, and moderately severe to severe level of depression, respectively. The difference was significant between groups. Depression severity was a significant predictor for health utility (standardized coefficient beta = −0.25), which was comparable with physical symptom burden and performance status. Participants' age, gender, cancer stage, and comorbid illness were not significant. The model explained 37.9% of the variance. Conclusions Even mild level of depression caused clinically meaningful decrement in health utility value in cancer patients, which was comparable with decrements due to major physical complications of cancer. Influence of depression should be carefully investigated when interpreting the quality-adjusted life year among cancer patients. Copyright © 2015 John Wiley & Sons, Ltd.

Fostering patients' sense of meaning is an essential task for palliative care clinicians. Few studies have reported the effects on nurses of a short-term training program aimed at improving skills to relieve feelings of meaninglessness in terminally ill cancer patients.The primary aim of this study was to determine the impact on nurses of a novel two-day education program focusing on care that addresses patients' feelings of meaninglessness. Measured were impacts on nurses' confidence, self-reported practice, attitudes toward caring for such patients, burnout, meaning of life, and knowledge.This study was a randomized controlled trial using the waiting list control. Intervention consisted of a two-day interactive education program. A total of 76 nurses randomly allocated to two groups completed the study. Outcome measures included confidence scale; self-reported practice scale; scales of nursing attitudes toward caring for patients who experience feelings of meaningless (willingness to help, positive appraisal, helplessness, nurse-perceived value of being, and nurse-perceived value of patients' inner power); Maslach burnout scale, Functional Assessment of Chronic Illness Therapy-Spiritual, and knowledge scale.There were significant intervention effects in nurse-reported confidence and nurse-perceived value of patients' inner power. Nurse-reported helplessness showed marginally significant improvement after intervention (p=0.067). No significant intervention effects were observed in the self-reported practice scale; attitudes toward caring for patients (willingness to help, positive appraisal, and nurse-perceived value of being); burnout scale, meaning of life; and knowledge score. The percentages of nurses who evaluated this program as useful or very useful were 95% (understanding the conceptual framework) and 85% (helping to learn how to provide care for patients feeling meaninglessness in clinical practice).This short-term educational intervention had a significant beneficial effect on nurses' confidence and modest effects on attitudes.

Objectives: To clarify the duration required for dyspnea to return to baseline severity after fan therapy, to evaluate whether fan-to-legs therapy or no fan therapy would be a suitable control therapy, and to investigate changes in patients’ face surface temperature after fan therapy. Methods: In this pilot study, all participants received 3 interventions in the following order: no fan, fan to legs, and fan to face. Participants used a fan for 5 minutes, and they scored their dyspnea at 10-minute intervals for 60 minutes or until the score had returned to its baseline value, whichever occurred first. Nine patients with advanced cancer admitted to a palliative care unit were included; they had dyspnea at rest and rated its severity as at least 3 points on a 0- to 10-point numerical rating scale. Descriptive statistics and the Wilcoxon signed rank test were used to analyze the data. Results: All patients completed the study. Of the 9 participants, 6 experienced a clinical benefit from using a fan to their faces. Of these patients, only 2 participants’ (2 of 6) dyspnea scores returned to baseline by the end of the 60-minute assessment period after exposure to fan-to-face therapy. In fan-to-legs and no fan settings, there was no change in the dyspnea scores. There were significant differences between the baseline face surface temperature and that after fan-to-face and fan-to-legs settings. Conclusion: When using a crossover design to investigate the effect of fan therapy on dyspnea, 1 hour is an insufficient washout period.

Background Yokukansan (YKS), a Japanese traditional herbal medicine for neurosis and insomnia, is speculated to be useful for perioperative psychiatric symptoms in cancer patients, but there exists little empirical evidence. This study provides preliminary data about the efficacy, feasibility, and side effects of YKS for the treatment of preoperative anxiety and postoperative delirium in cancer patients. Methods We retrospectively reviewed the medical records of colorectal cancer patients who took YKS for preoperative anxiety, evaluating the following: (1) patient characteristics, (2) feasibility of taking YKS, (3) changes in preoperative anxiety based on the Clinical Global Impression (CGI) scale and Edmonton Symptom Assessment System-revised (ESAS-r-anxiety), (4) incidence of postoperative delirium and (5) YKS-related side effects. Results We reviewed 19 medical records. There was a significant difference between ESAS-r-anxiety scores (P = 0.028) before and after taking YKS, but no difference between CGI scores (P = 0.056). The incidence of postoperative delirium was 5.2% (95% CI = 0.0-14.5). One patient could not complete the course of YKS during the perioperative administration period, but there were no side effects of Grade 2 or worse according to the Common Terminology Criteria for Adverse Events v4. Conclusions Cancer patients could safely take YKS before surgery. There was a significant improvement in preoperative anxiety after taking YKS, and the incident rate of postoperative delirium was lower than in previous studies. These results suggest that YKS may be useful for perioperative psychiatric symptoms in cancer patients. Further well-designed studies are needed to substantiate our results.

Purpose The aim of this study was to identify the effects of a communication skills training (CST) program for oncologists, developed based on patient preferences regarding oncologists' communication. Participants and Methods Thirty oncologists were randomly assigned to either an intervention group (IG; 2-day CST workshop) or control group (CG). Participants were assessed on their communication performance during simulated consultation and their confidence in communicating with patients at baseline and follow-up. A total of 1,192 patients (response rate, 84.6%) who had consultations with the participating oncologists at baseline and/or follow-up were assessed regarding their distress using the Hospital Anxiety and Depression Scale, satisfaction with the consultation, and trust in their oncologist after the consultation. Results At the follow-up survey, the performance scores of the IG had improved significantly, in terms of their emotional support (P = .011), setting up a supportive environment (P = .002), and ability to deliver information (P = .001), compared with those of the CG. Oncologists in the IG were rated higher at follow-up than those in the CG in terms of their confidence in themselves (P = .001). Patients who met with oncologists after they had undergone the CST were significantly less depressed than those who met with oncologists in the CG (P = .027). However, the CST program did not affect patient satisfaction with oncologists' style of communication. Conclusion A CST program based on patient preferences is effective for both oncologists and patients with cancer. Oncologists should consider CST as an approach to enhancing their communication skills.

Although protracted cognitive impairment has been reported to occur after radiotherapy even when such therapy is not directed to brain areas, the mechanism remains unclear. This study investigated whether breast cancer patients exposed to local radiotherapy showed lower cognitive function mediated by higher plasma interleukin (IL)-6 levels than those unexposed. We performed the Wechsler Memory Scale-Revised (WMS-R) and measured plasma IL-6 levels for 105 breast cancer surgical patients within 1 year after the initial therapy. The group differences in each of the indices of WMS-R were investigated between cancer patients exposed to adjuvant regional radiotherapy (n = 51) and those unexposed (n = 54) using analysis of covariance. We further investigated a mediation effect by plasma IL-6 levels on the relationship between radiotherapy and the indices of WMS-R using the bootstrapping method. The radiotherapy group showed significantly lower Immediate Verbal Memory Index and Delayed Recall Index (P = 0.001, P = 0.008, respectively). Radiotherapy exerted an indirect effect on the lower Delayed Recall Index of WMS-R through elevation of plasma IL-6 levels (bootstrap 95% confidence interval = -2.6626 to -0.0402). This study showed that breast cancer patients exposed to adjuvant regional radiotherapy in conservation therapy might have cognitive impairment even several months after their treatment. The relationship between the therapy and the cognitive impairment could be partially mediated by elevation of plasma IL-6 levels.

Background:Depressive symptoms are common in patients with Alzheimer's disease (AD) and increase the caregiver burden, although the etiology and pathologic mechanism of depressive symptoms in AD patients remain unclear. In this study, we tried to clarify the cerebral blood flow (CBF) correlates of subjective depressive symptoms in AD.Methods:Seventy-six consecutive patients with AD were recruited from outpatient units of the Memory Clinic of Okayama University Hospital. Subjective depressive symptoms were evaluated using the short version of the Geriatric Depression Scale (GDS). All patients underwent brain SPECT with 99mTc-ethylcysteinate dimer, and the SPECT images were analyzed by the Statistical Parametric Mapping 8 program.Results:No significant differences between groups with high and low GDS scores were found with respect to age, sex, years of education, and revised Addenbrooke's Cognitive Examination scores. Compared to patients with low scores on GDS, patients with high scores showed significant hypoperfusion in the left inferior frontal region.Conclusions:The left inferior frontal region may be significantly involved in the pathogenesis of subjective depressive symptoms in AD. Subjective and objective depressive symptoms may have somewhat different neural substrates in AD.