Smartphone-based distress screening, information provision, and psychotherapy for reducing psychological distress among AYA cancer survivors: protocol for a fully decentralized multicenter randomized controlled clinical trial.

Fear of cancer recurrence (FCR) is a common and distressing condition among adolescents and young adults (AYAs). This study aims to investigate the efficacy of digital interventions, including distress screening-based information provision and smartphone problem-solving therapy, on common psychological distress, especially FCR, in AYA patients with cancer. Participants will be 224 AYA outpatients with cancer aged 15-39 years who will be randomly assigned to either an 8-week smartphone-based intervention or a waitlist control group. This intervention includes smartphone-based distress screening, information provision, and psychotherapy (problem-solving therapy). The primary endpoint will be the Fear of Cancer Recurrence Inventory-Short Form score at week 8. This study will be conducted as a fully decentralized, randomized, and multicenter trial. The study protocol was approved by the Institutional Review Board of Nagoya City University on 19 April 2024 (ID: 46-23-0005). Trial registration: UMIN-CTR: UMIN000054583.

Optimizing smartphone psychotherapy for depressive symptoms in patients with cancer: Multiphase optimization strategy using a decentralized multicenter randomized clinical trial (J-SUPPORT 2001 Study).

AIM: Patients with cancer experience various forms of psychological distress, including depressive symptoms, which can impact quality of life, elevate morbidity risk, and increase medical costs. Psychotherapy and pharmacotherapy are effective for reducing depressive symptoms among patients with cancer, but most patients prefer psychotherapy. This study aimed to develop an efficient and effective smartphone psychotherapy component to address depressive symptom. METHODS: This was a decentralized, parallel-group, multicenter, open, individually randomized, fully factorial trial. Patients aged ≥20 years with cancer were randomized by the presence/absence of three cognitive-behavioral therapy (CBT) skills (behavioral activation [BA], assertiveness training [AT], and problem-solving [PS]) on a smartphone app. All participants received psychoeducation (PE). The primary outcome was change in the patient health questionnaire-9 (PHQ-9) total score between baseline and week 8. Secondary outcomes included anxiety. RESULTS: In total, 359 participants were randomized. Primary outcome data at week 8 were obtained for 355 participants (99%). The week 8 PHQ-9 total score was significantly reduced from baseline for all participants by -1.41 points (95% confidence interval [CI] -1.89, -0.92), but between-group differences in change scores were not significant (BA: -0.04, 95% CI -0.75, 0.67; AT: -0.16, 95% CI -0.87, 0.55; PS: -0.19, 95% CI -0.90, 0.52). CONCLUSION: As the presence of any of the three intervention components did not contribute to a significant additive reduction of depressive symptoms, we cannot make evidence-based recommendations regarding the use of specific smartphone psychotherapy.

Epidemiology of skin cancer based on Japan's National Cancer Registry 2016-2017.

Skin cancer is most frequently diagnosed in the White population. However, its subtypes and epidemiology in Japan are understudied. We aimed to elucidate skin cancer incidence in Japan based on the National Cancer Registry, a new nationwide integrated population-based registry. Data from patients diagnosed with skin cancer in 2016 and 2017 were extracted and classified by cancer subtypes. Data were analyzed using the World Health Organization and General Rules tumor classifications. Tumor incidence was calculated as the number of new cases divided by the corresponding total person-years. Overall, 67,867 patients with skin cancer were included. The percentage of each subtype was as follows: basal cell carcinoma, 37.2%; squamous cell carcinoma, 43.9% (18.3% of which, in situ); malignant melanoma, 7.2% (22.1% of which, in situ); extramammary Paget's disease, 3.1% (24.9% of which, in situ); adnexal carcinoma, 2.9%; dermatofibrosarcoma protuberans, 0.9%; Merkel cell carcinoma, 0.6%; angiosarcoma, 0.5%; and hematologic malignancies, 3.8%. The overall age-adjusted incidence of skin cancer was 27.89 for the Japanese population model and 9.28 for the World Health Organization (WHO) model. The incidences of basal cell carcinoma and squamous cell carcinoma were the highest (3.63 and 3.40 per 100,000 persons, respectively, in the WHO model) among skin cancers, whereas the incidences of angiosarcoma and Merkel cell carcinoma were the lowest (0.026 and 0.038 per 100,000 persons, respectively, in the WHO model). This is the first report to provide comprehensive information on the epidemiological status of skin cancers in Japan using population-based NCR data.

Protocol for a confirmatory trial of the effectiveness and safety of palliative arterial embolization for painful bone metastases.

BACKGROUND: Transcatheter arterial embolization (TAE) has long been used for hemostasis of traumatic or postoperative hemorrhage and embolization of tumors. Previous retrospective studies of TAE for painful bone metastases showed 60%-80% pain reduction with a median time to response of 1-2 days. Compared with radiotherapy and bisphosphonates, time to response appeared earlier than that of radiotherapy or bone-modifying agents. However, few prospective studies have examined TAE for this indication. Here, we describe the protocol for a confirmatory study designed to clarify the efficacy and safety profile of TAE. METHODS: This study will be a multicenter, single-arm confirmatory study (phase 2-3 design). Patients with painful bone metastases from any primary tumor are eligible for enrollment. TAE will be the main intervention. Following puncture of the femoral artery under local anesthesia and insertion of an angiographic sheath, angiography will confirm that the injected region includes tumor vasculature. Catheter position will be adjusted so that the embolization range does not include non-target tissues. Spherical embolic material will then be slowly injected into the artery to embolize it. The primary endpoint (efficacy) is the proportion of subjects with pain relief at 72 h after TAE and the secondary endpoint (safety) is the incidence of all NCI Common Terminology Criteria for Adverse Events version 5.0 Grade 4 adverse events and Grade ≥ 3 necrosis of the central nervous system. DISCUSSION: If the primary and secondary endpoints are met, TAE can be a treatment choice for painful bone metastases. Trial registry number is UMIN-CTR ID: UMIN000040794. TRIAL REGISTRATION: The study is ongoing, and patients are currently being enrolled. Enrollment started in March 2021. A total of 36 patients have participated as of Aug 2022. PROTOCOL VERSION: Ver1.4, 13/07/2022.

Perceptions toward issues in cancer care for people with mental illness among psychiatric care providers: A questionnaire study.

OBJECTIVES: To reduce cancer care disparities in people with mental illness, this study aimed to quantify psychiatric care providers' perceptions regarding issues that are insufficiently addressed or difficult to address. METHODS: Psychiatric care providers at 23 psychiatric hospitals in Japan were surveyed using mail questionnaires. Respondents were asked to rate 15 items with four categories related to insufficiencies/difficulties in cancer care for patients with mental illness on a five-point Likert scale. We analyzed the proportion of respondents who answered "insufficient/difficult" for each item. RESULTS: A total of 255 (76.3%) psychiatric care providers responded. For questions related to the skills and attitudes of psychiatric professionals, 48.3%-58.4% of respondents perceived that efforts for supporting cancer screening and treatment were insufficient. For the questions related to collaborations between cancer and psychiatric care providers, 75.3% of respondents perceived that inpatient visits between psychiatric and cancer hospitals were insufficient. For the questions related to in-psychiatric-hospital medical systems, 50.2%-87.2% of respondents perceived that support for screening, diagnosis/treatment, and palliative care for psychiatric inpatients were insufficient/difficult. 41.9%-57.4% of respondents perceived that social services in the community were insufficient. CONCLUSIONS: This study clarified the level of insufficiency/difficulty perceived by psychiatric care providers regarding issues related to cancer care for people with mental illness. Psychiatric care providers are required to have knowledge and skills in cancer screening and treatment. To improve access to cancer prevention, treatment, and palliative care, it may be helpful to establish systems to promote coordination between cancer hospitals and psychiatric hospitals.

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.

Prevalence and associated factors of psychological distress among young adult cancer patients in Japan.

OBJECTIVES: Adolescent and young adult (AYA) cancer patients may be at high risk of experiencing psychological distress because their diagnosis came during a key time of consolidation of identity and social growth. This study aimed (1) to examine the prevalence of psychological distress among AYA cancer patients within a year of diagnosis to long-term survivors and (2) to describe socio-demographic and cancer-related characteristics associated with psychological distress. METHODS: In a cross-sectional web-based survey, patients who scored 5 or more on the Kessler Psychological Distress Scale were assessed for significant psychological distress. Logistic regression examined whether demographics, clinical variables, and social support were associated with psychological distress. RESULTS: A total of 206 young adult cancer patients participated. The median age at the survey was 34.5 years (range: 22-39 years), and 87.4% were female. The prevalence of psychological distress was 55.3%. Psychological distress among patients diagnosed within a year and long-term survivors (≥10 years since diagnosis) was significantly higher than patients 1-4 years since diagnosis. Pain, decrease in income after a cancer diagnosis, experience of negative change in work/school after a cancer diagnosis and poor social support were significantly associated with psychological distress. SIGNIFICANCE OF RESULTS: Over half of young adult patients had significant psychological distress in Japan. Our findings potentially contribute to the intervention components for distress management among AYA cancer survivors.

Validation of the Japanese version of the full and short form Trust in Oncologist Scale.

OBJECTIVES: This study aimed to validate the Japanese versions of the Trust in Oncologist Scale (TiOS-J) and the TiOS-Short Form (TiOS-SF-J). METHODS: A cross-sectional web-based survey was conducted among cancer patients in Japan. The forward-backward translation method was used to develop the TiOS-J. The web-based survey was mailed to 633 people, of whom 309 responded. After 2 weeks, 103 among the 156 first-time respondents completed the second survey to verify the reliability of the retest method. The validity was evaluated by exploratory factor analysis (EFA), confirmatory factor analysis (CFA), Spearman's correlation coefficients between the Patient Satisfaction Questionnaire-Japanese, willingness to recommend the oncologist, trust in health care, and number of oncological consultations. To evaluate reliability, Cronbach's α and test-retest correlation were calculated. RESULTS: The theoretically driven four-factor model and the EFA-driven one-factor model of the full-form TiOS-J (18 items) did not result in an acceptable fit; however, CFA supported the one-dimensionality of the 5 items from the TiOS-SF-J (χ2 (5) = 12.36, p = 0.03, goodness-of-fit index = 0.984, adjusted goodness-of-fit index = 0.952, comparative fit index = 0.991, and root mean square error of approximation = 0.069). With regard to the reliability of TiOS-J and TiOS-SF-J, the Cronbach's alpha values were 0.94 and 0.89, respectively; the test-retest values were 0.82 and 0.78. SIGNIFICANCE OF RESULTS: This study indicated that the TiOS-J and TiOS-SF-J are valid and reliable instruments for measuring patients' trust in their oncologists and can be used to assess trust in oncologists for both clinical and research purposes.

Issues of cancer care in people with mental disorders as perceived by cancer care providers: A quantitative questionnaire survey.

OBJECTIVES: To reduce cancer care disparities, this study aimed to clarify the difficulties in cancer care for people with mental disorders as perceived by cancer care providers. METHODS: Cancer care providers at 17 designated cancer hospitals in Japan were surveyed using mail questionnaires. Respondents were asked to rate 29 items related to difficulties or insufficiencies in cancer care for patients with mental disorders on a five-point Likert scale. We analyzed the proportion of respondents who answered "difficult/insufficient" in each item. We also calculated the proportions of responders stratified according to the presence of psychiatric support systems within their hospitals. RESULTS: A total of 388 (58.4%) cancer care providers responded. Among the issues related to "difficulties in diagnosing and treating cancer," support for decision-making, assessment of treatment adherence, and assessment of physical symptoms were perceived as most difficult (73.5%-81.5% of respondents). Among the issues related to 'difficulties or insufficiencies in collaboration among multidisciplinary health care providers,' the issue of advance consultation and sharing information with the patient's primary psychiatric care provider was perceived as most difficult (52.2%). Among the issues related to "insufficiencies of in-hospital and community medical systems," education to provide reasonable accommodation was perceived as most insufficient (47.4%). The perceived difficulties of over half of the issues varied significantly between hospitals depending on the level of psychiatric support systems. CONCLUSIONS: This study clarified the difficulties of cancer care in patients with mental disorders as perceived by cancer care providers. Some issues may be resolved by psychiatric liaison teams.

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.

Prevention of delirium with agitation by yokukansan in older adults after cancer surgery.

OBJECTIVE: Preventing postoperative delirium with agitation is vital in the older population. We examined the preventive effect of yokukansan on postoperative delirium with agitation in older adult patients undergoing highly invasive cancer resection. METHODS: We performed a secondary per-protocol analysis of 149 patients' data from a previous clinical trial. Patients underwent scheduled yokukansan or placebo intervention 4-8 days presurgery and delirium assessment postoperatively. Delirium with agitation in patients aged ≥75 years was assessed using the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, and the Japanese version of the Delirium Rating Scale-Revised-98. We assessed odds ratios for yokukansan (TJ-54) compared with placebo for the manifestation of postoperative delirium with agitation across patients of all ages (n = 149) and those aged ≥65 years (n = 82) and ≥ 75 years (n = 21) using logistic regression. RESULTS: Delirium with agitation manifested in 3/14 and 5/7 patients in the TJ-54 and placebo groups, respectively, among those aged ≥75 years. The odds ratio for yokukansan vs. placebo was 0.11 (95% confidence interval: 0.01-0.87). An age and TJ-54 interaction effect was detected in patients with delirium with agitation. No intergroup differences were observed in patients aged ≥65 years or across all ages for delirium with agitation. CONCLUSIONS: This is the first study investigating the preventive effect of yokukansan on postoperative delirium with agitation in older adults. Yokukansan may alleviate workforce burdens in older adults caused by postoperative delirium with agitation following highly invasive cancer resection.

Validity and reliability of the Japanese version of the Peace, Equanimity, and Acceptance in the Cancer Experience (PEACE) questionnaire.

OBJECTIVE: The purpose of this study was to investigate the validity and reliability of the Japanese version of the Peace, Equanimity, and Acceptance in the Cancer Experience questionnaire (PEACE-J) and to evaluate the association between the PEACE subscales and Japanese patient characteristics. METHODS: A cross-sectional web-based survey was conducted among 412 patients with cancer. This survey assessed medical and demographic factors, such as the PEACE, the Coping Inventory for Stressful Situations (CISS), and the Functional Assessment of Chronic Illness Therapy - Spiritual well-being (FACIT-Sp). The forward-backward translation method was used to develop the PEACE-J. The validity of PEACE-J was evaluated by exploratory and confirmatory factor analysis, and correlation analysis between each subscale of PEACE and FACIT-Sp and CISS. The Cronbach's α and the item-total correlation of each subscale of the PEACE questionnaire were calculated to assess internal consistency reliability. RESULTS: The factor analysis yielded two subscales corresponding to the original version: Cronbach's α coefficients were 0.84 and 0.86 for the Peaceful Acceptance of Illness subscale and the Struggle with Illness subscale, respectively. The PEACE subscales and the FACIT-Sp subscales and the CISS subscales were moderately associated with each other, including the Peaceful Acceptance to each subscale of FACIT (r = 0.22-0.55, p < 0.01); and the Peaceful Acceptance and the Struggle with Illness to CISS emotion-oriented coping (r = -0.36 and r = 0.45, p < 0.01, respectively). Married patients showed higher levels of peaceful acceptance than unmarried patients (p < 0.001). Poorer performance status, chemotherapy use, and recurrence or metastasis were significantly associated with higher levels of struggle with illness (p < 0.001). SIGNIFICANCE OF RESULTS: This study indicated that the PEACE-J is a valid and reliable measure of the patient's sense of acceptance, calmness or equanimity, and peace, as well as their sense of struggle or desperation concerning their illness.

Assessing the need for a question prompt list that encourages end-of-life discussions between patients with advanced cancer and their physicians: A focus group interview study.

OBJECTIVE: Early integration of palliative and cancer care improves the quality of life and is facilitated by discussions about the end of life after cessation of active cancer treatment between patients with advanced cancer and their physicians. However, both patients and physicians find end-of-life discussions challenging. The aim of this study was to assess the need for a question prompt list (QPL) that encourages end-of-life discussions between patients with advanced cancer and their physicians. METHODS: Focus group interviews (FGIs) were conducted with 18 participants comprising 5 pancreatic cancer patients, 3 family caregivers, 4 bereaved family members, and 6 physicians. Three themes were discussed: question items that should be included in the QPL that encourages end-of-life discussions with patients, family caregivers, and physicians after cessation of active cancer treatment; when the QPL should be provided; and who should provide the QPL. Each interview was audio-recorded, and content analysis was performed. RESULTS: The following 9 categories, with 57 question items, emerged from the FGIs: (1) preparing for the end of life, (2) treatment decision-making, (3) current and future quality of life, (4) current and future symptom management, (5) information on the transition to palliative care services, (6) coping with cancer, (7) caregivers' role, (8) psychological care, and (9) continuity of cancer care. Participants felt that the physician in charge of the patient's care and other medical staff should provide the QPL early during active cancer treatment. SIGNIFICANCE OF RESULTS: Data were collected to develop a QPL that encourages end-of-life discussions between patients with advanced cancer and their physicians.

Unmet supportive care needs and associated factors among young adult cancer patients in Japan.

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.

Cancer care for people with mental disorders: A qualitative survey among cancer care and psychiatric care professionals in Japan.

OBJECTIVE: It is widely assumed that there are multiple levels (from individual to policy level) of problems involving disparities in cancer care for people with mental disorders. However, few studies have comprehensively investigated issues as perceived by medical professionals. The purpose of the present study was to identify a wide range of issues in cancer care for people with mental disorders and offer corresponding solutions for both cancer care professionals and psychiatric care professionals. METHODS: We distributed open-ended questionnaires to 754 healthcare professionals in various medical facilities, including designated cancer hospitals, psychiatric hospitals, and other local healthcare/welfare facilities. Participants were asked to describe issues in cancer care for people with mental disorders. RESULTS: Of the 754 recruited professionals, 439 (58.2%) responded to the questionnaire. Sixty-one issues were extracted and categorized into 10 categories: patient factors; isolation and lack of support; obstacles to transport; socioeconomic factors; attitudes of psychiatric professionals; medical system of psychiatric hospitals; attitudes of cancer care professionals; medical system of designated cancer hospitals; regional cancer medical systems; and lack of coordination among multidisciplinary healthcare professionals. Forty-eight specific solutions were summarized into 12 goals. CONCLUSIONS: The present study widely identified issues causing disparities in cancer care for patients with mental disorders. We found that the issues extended from the patient level to the public-policy level. Our findings suggest the need for a multidisciplinary approach that includes both cancer and psychiatric care professionals to address the gap in cancer care for people with mental disorders.

Encouraging participation in colorectal cancer screening for people with schizophrenia: A randomized controlled trial.

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 < 0.0001). The proportion of lung cancer screening also increased. No serious adverse events associated with the study intervention occurred. CONCLUSION: The case management intervention to encourage participation in colorectal cancer screening was effective for patients with schizophrenia.

Establishment of a research policy for supportive and palliative care in Japan.

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.

Death by suicide, other externally caused injuries and cardiovascular diseases within 6 months of cancer diagnosis (J-SUPPORT 1902).

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.

Validity and Reliability of the Japanese Version of the 12-item Self-administered World Health Organization Disability Assessment Schedule (WHODAS) 2.0 in Patients with Schizophrenia.

It is necessary to assess functional impairment when treating schizophrenia. The World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) has been adopted as a measure of functional disability in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. This study was a secondary analysis from a cross-sectional study of health-related behaviors among patients with schizophrenia. We examined the validity and reliability of the Japanese version of the 12-item WHODAS 2.0 when self-administered by such patients. Participants were 350 outpatients with schizophrenia from a psychiatric hospital. The standard six-factor structure of the WHODAS 2.0 showed a good fit for these participants. The Cronbach's alpha coefficient was 0.858, showing good internal consistency. The WHODAS 2.0 showed moderate correlations with the modified Global Assessment of Functioning and Kessler 6 scales (r=-0.434 and 0.555, respectively). The results of this study show that the Japanese version of the 12-item self-administered WHODAS 2.0 has good internal consistency and convergent validity among patients with schizophrenia. Further exploration of the usefulness of WHODAS 2.0 in clinical settings is needed.

Olanzapine 5 mg plus standard antiemetic therapy for the prevention of chemotherapy-induced nausea and vomiting (J-FORCE): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

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<0·0001). One patient had grade 3 constipation and one patient had grade 3 somnolence related to treatment in the olanzapine group. 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.