Tomomi Narisawa

OBJECTIVES: High physical activity levels have been associated with longer, healthier lifespans and improved quality of life among breast cancer survivors. The Japanese clinical guidelines for breast cancer survivors, similar to those in the USA, strongly recommend maintaining high physical activity levels. However, the extent of adherence to these guidelines among breast cancer survivors in Japan is unclear. This study aimed to assess adherence to guideline-recommended physical activities and identify associated factors. METHODS: Self-administered questionnaires were distributed to breast cancer survivors without recurrence or metastasis from 34 facilities across Japan, with approximately 30 survivors per facility, between March 2019 and August 2020. The questionnaire collected information on participants' backgrounds, physical activity levels (assessed using the Global Physical Activity Questionnaire) and potential factors influencing their physical activity. Logistic regression analysis was performed to identify the factors associated with meeting the guideline recommendations. RESULTS: In total, 791 patients (77.5%) were investigated, with 50.5% meeting the physical activity recommendations outlined in the guidelines. Factors associated with meeting the guideline recommendations included higher self-efficacy (OR 1.58, 95% CI 1.29 to 1.94), greater perceived social support (OR 1.54, 95% CI 1.26 to 1.89), lower annual household income (OR 1.58, 95% CI 1.07 to 2.33), relief from cancer-related symptoms through physical activity (OR 1.81, 95% CI 1.13 to 2.94) and urban location (OR 1.50, 95% CI 1.03 to 2.20). CONCLUSIONS: Half of the breast cancer survivors in Japan did not meet the recommended physical activity levels, and several factors influencing adherence were identified.

IMPORTANCE: Cognitive processing therapy (CPT) is an evidence-based treatment for posttraumatic stress disorder (PTSD). However, there is little evidence on the efficacy of CPT in East Asia. OBJECTIVE: To evaluate whether CPT is effective in treating PTSD among outpatients in a Japanese medical setting. DESIGN, SETTING, AND PARTICIPANTS: This randomized clinical trial used a 16-week, single-center, assessor-blinded, parallel-group superiority design to examine the efficacy of CPT in conjunction with treatment as usual (CPT-TAU) vs waiting list with TAU (WL-TAU) from April 2016 through December 2022. The trial included adult patients with PTSD at a national psychiatric referral hospital in Tokyo, Japan. Analysis was based on intention to treat and per protocol and was performed from February 1 to April 30, 2024. INTERVENTIONS: Participants were randomized 1:1 to CPT-TAU (n = 29), which consisted of 12 weekly individual CPT sessions, or WL-TAU (n = 31), which consisted of clinical monitoring and/or pharmacotherapy. MAIN OUTCOMES AND MEASURES: The primary outcome was the Clinician-Administered PTSD Scale (CAPS-5) score for the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) at 17 weeks. Secondary outcomes included self-reported PTSD symptoms assessed by the PTSD Checklist-5 and responder status at 17 weeks. Adverse events were evaluated using the Japanese version of the Common Terminology Criteria for Adverse Events, version 4.0. RESULTS: Among 60 eligible participants (all included in the intention-to-treat analysis), mean (SD) age was 36.9 (9.9) years; 54 (90.0%) were women. The CPT-TAU group showed a mean (SE) reduction in CAPS-5 scores of 14.00 (1.92) points, with a low dropout rate (2 of 29 [6.9%]). Patients in the CPT-TAU group showed superiority in all secondary and other outcomes. The mean change difference was observed in depression (8.83; 95% CI, 6.00-11.66), suicidal ideation (6.73; 95% CI, 1.25-12.22), disability (8.16; 95% CI, 3.90-12.43), clinical global impression (0.84; 95% CI, 0.41-1.26), and loss of principal PTSD diagnosis (59.09; 95% CI, 37.19-81.00). There were no serious adverse events in the CPT-TAU group and 3 serious adverse events in the WL-TAU group during the intervention period. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of CPT-TAU vs WL-TAU, CPT was superior in reducing PTSD symptoms. These results strengthen the evidence for use of CPT in East Asian populations. TRIAL REGISTRATION: Umin.Uc.Jp/Ctr Identifier: UMIN000021670.

Background: Recent practice guidelines strongly recommend evidence-based psychotherapies (EBPs) as the first-line treatment for post-traumatic stress disorder (PTSD). However, previous studies found barriers to the implementation of EBPs and a relatively high dropout rate in clinical settings. After proving the efficacy of prolonged exposure (PE) in Japan [Asukai, N., Saito, A., Tsuruta, N., Kishimoto, J., & Nishikawa, T. (2010). Efficacy of exposure therapy for Japanese patients with posttraumatic stress disorder due to mixed traumatic events: A randomized controlled study. Journal of Traumatic Stress, 23(6), 744-750. https://doi.org/10.1002/jts.20589], we began implementing PE in a real-world clinical setting at the Victim Support Center of Tokyo (VSCT).Objective: We aimed to investigate the effectiveness and benefit of PE for crime-induced PTSD among VSCT clients and what causes dropout from treatment.Method: Of 311 adult clients who received counselling from clinical psychologists at VSCT due to violent or physical crime victimization from April 2008 through December 2019, 100 individuals received PE and participated in this study. Their PTSD symptoms were evaluated before and after treatment using the Impact of Event Scale-Revised and the Clinician-Administered PTSD Scale for DSM-IV.Results: A total of 93 participants completed PE and seven dropped out after six sessions or less. The completers group improved in PTSD symptoms with significant score differences between pre- and post-treatment in IES-R and CAPS-IV. Participants' symptoms did not exacerbate after treatment. Forty of 49 completers who left their workplace or college/school after victimization returned to work or study shortly after treatment. Compared to the completers, all dropout participants were women and younger. The majority were rape survivors, with significantly shorter intervals between victimization and treatment. The reasons for dropout were difficulty scheduling treatment between work/study schedules and manifestation of bipolar disorder or physical illness.Conclusions: PE can be implemented with significant effectiveness and a low dropout rate in a real-world clinical setting if advantages in the system and policies, local organizational context, fidelity support and patient engagement are fortified.

Cognitive processing therapy (CPT) is one of the most widely tested evidence-based treatments for posttraumatic stress disorder (PTSD). However, most studies on CPT have been conducted in Western cultural settings. This open-label, single-arm trial investigated the feasibility, acceptability, and preliminary efficacy of CPT for treating Japanese patients with PTSD. A total of 25 outpatients underwent 12 CPT sessions. The primary outcome was the assessment of PTSD symptoms using the Clinician-Administered PTSD Scale for DSM-IV (CAPS-IV); secondary outcomes included the assessment of subjective PTSD severity, depressive and anxiety symptoms, trauma-related cognitions, and subjective quality of life. All outcomes were evaluated at pretreatment (i.e., baseline), posttreatment, and 6- and 12-month follow-ups. On average, participants attended 13 sessions of CPT (SD = 1.38), with a completion rate of 96.0%. One serious adverse event (hospitalization) occurred. Significant within-subjects standardized mean differences in CAPS-IV scores were found from baseline to treatment completion, g = -2.28, 95% CI [-3.00, -1.56]; 6-month follow-up, g = -2.95, 95% CI [-3.79, -2.12]; and 12-month follow-up, g = -2.15, 95% CI [-2.89, -1.41]. Moderate-to-large effects, gs = -0.77 to -2.45, were found on secondary outcomes. These findings support the feasibility, acceptability, and preliminary efficacy of CPT in a Japanese clinical setting.

OBJECTIVE: Insomnia is an increasingly recognized major symptom of breast cancer which can seriously disrupt the quality of life during and many years after treatment. Sleep problems have also been linked with survival in women with breast cancer. The aims of this study were to estimate the prevalence of insomnia in breast cancers survivors, clarify the clinical characteristics of their sleep difficulties and use machine learning techniques to explore clinical insights. METHODS: Our analysis of data, obtained in a nationwide questionnaire survey of breast cancer survivors in Japan, revealed a prevalence of suspected insomnia of 37.5%. With the clinical data obtained, we then used machine learning algorithms to develop a classifier that predicts comorbid insomnia. The performance of the prediction model was evaluated using 8-fold cross-validation. RESULTS: When using optimal hyperparameters, the L2 penalized logistic regression model and the XGBoost model provided predictive accuracy of 71.5 and 70.6% for the presence of suspected insomnia, with areas under the curve of 0.76 and 0.75, respectively. Population segments with high risk of insomnia were also extracted using the RuleFit algorithm. We found that cancer-related fatigue is a predictor of insomnia in breast cancer survivors. CONCLUSIONS: The high prevalence of sleep problems and its link with mortality warrants routine screening. Our novel predictive model using a machine learning approach offers clinically important insights for the early detection of comorbid insomnia and intervention in breast cancer survivors.

BACKGROUND: A strategy for maintaining and/or improving cardiorespiratory fitness (CRF) in the growing population of cancer survivors is of major clinical importance, especially in the COVID-19 era. The effect of unsupervised high-intensity interval training (HIIT) on increasing CRF in breast cancer survivors is unknown. PURPOSE: The purpose of this study was to determine whether the newly developed habit-B programme, which involves home-based smartphone-supported HIIT using body weight exercises, improves CRF in early-stage breast cancer survivors. METHODS: This single-centre, 12-week, parallel-group, single-blind, randomised controlled trial involved 50 women with stage I-IIa breast cancer, aged 20-59 years, who had completed initial treatment except for hormone therapy. Participants were randomised to either the exercise or control group. The primary outcome was the 12-week change in peak oxygen uptake [Formula: see text]. Other outcomes included muscle strength, 6 min walk test, resting heart rate, physical activity, fatigue, safety and quality of life. RESULTS: The change in [Formula: see text] and leg strength increased significantly in the exercise group compared with the control group (p<0.01). Changes in other outcomes were not significantly different between the groups. CONCLUSION: A home-based HIIT intervention can lead to improve CRF and muscle strength in early-stage breast cancer survivors.

Background: Posttraumatic stress disorder (PTSD) symptoms are known to occur after acute coronary syndrome (ACS). Peritraumatic distress has been indicated as a risk factor for PTSD and can be measured by the Peritraumatic Distress Inventory (PDI). However, no studies have yet measured peritraumatic distress after ACS using the PDI to predict PTSD. Objectives: This prospective cohort study examined the impact of peritraumatic distress on PTSD symptoms at 6 months after ACS. Methods: We used the PDI to assess peritraumatic distress in patients treated for ACS at a teaching hospital in Tokyo within 7 days after percutaneous coronary intervention. They were followed up over the next 6 months and were assessed for PTSD symptoms at 6 months using the Impact of Event Scale-Revised. The association between peritraumatic distress and PTSD symptoms was examined by multiple linear regression analysis. Results: The study enrolled 101 ACS patients, and 97 completed the follow-up assessment. PDI total score was an independent predictor of PTSD symptoms after adjustment for potential covariates (beta = 0.38; p < 0.01). Limitations: The results were obtained from a single teaching hospital and assessment of PTSD symptoms was questionnaire based. Conclusion: We provide the first evidence that PDI score can predict the development of PTSD symptoms in ACS patients. Assessing peritraumatic distress after ACS with the PDI may be useful for initiating early intervention against PTSD symptoms.

INTRODUCTION: A major concern is that few cancer survivors meet the guidelines for recommended levels of physical activity. No studies have investigated physical activity among breast cancer survivors nationwide in Japan. Therefore, the aims of this study are to identify the levels of physical activity among breast cancer survivors, to examine factors-related physical activity among breast cancer survivors and to identify breast cancer survivors' preferences for and interest in exercise programmes in order to inform the future programme development. METHODS AND ANALYSIS: We will administer a cross-sectional survey using a self-report questionnaire to breast cancer survivors. At each of 50 facilities selected to include a variety of institutional backgrounds according to the population distribution of different regions throughout Japan, we will consecutively distribute the questionnaire to 30 outpatients who have completed initial treatments, except for hormone therapy. The target sample size is 1500 survivors. We will calculate descriptive statistics for each measurement item and perform univariate and multivariate analyses using outcome measures (eg, physical activity and quality of life) related to physical, psychological, social and environmental factors. DISCUSSION: This is the first nationwide survey of physical activity levels among breast cancer survivors in Japan. Identifying the factors associated with physical activity will help us to develop, disseminate and implement programmes that encourage more survivors to adhere to physical activity guidelines. ETHICS AND DISSEMINATION: The protocol was approved by the Institutional Review Board (IRB) of the National Cancer Center on 11 January 2019 (ID: 2018-295). In addition, many of the participating facilities required ethical approval from their local IRBs, while others did not. Accordingly, approval from the local IRBs of individual facilities was obtained when required. The findings will be disseminated through peer-reviewed publications and conference presentations.

PURPOSE: To develop consensus-based components used in the first evidence-based cancer survivorship guidelines in Japan. METHODS: 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. RESULTS: 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. CONCLUSION: 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. IMPLICATIONS FOR CANCER SURVIVORS: A culturally sensitive consensus approach was developed to improve the long term health and well- being of cancer survivors in Japan.

Cardiovascular disease is a known risk factor for the development of psychiatric disorder and about 20% of patients with acute coronary syndrome (ACS) develop depression. Our previous prospective study showed that serum linoleic acid (LA) level at baseline (admission) is a risk factor for the development of psychiatric disorder 3 months later. However, it was unclear whether serum LA could predict psychiatric disorders after 3 months. Thus, we examined the effects of polyunsaturated fatty acid (PUFA) levels at ACS onset on comorbid psychiatric disorders at 6 months. The study involved a follow-up investigation of the previous prospective cohort study of ACS patients. The sample with complete participant data at 6 months post-ACS comprised 100 patients. On admission, serum n-3 and n-6 PUFA levels were measured by gas chromatography and patients were interviewed to obtain medical information. Eight patients (8%) showed psychiatric disorder at 6 months. The association between psychiatric disorder and serum PUFA concentrations at ACS onset was examined by multivariable logistic regression analysis. Psychiatric disorders were predicted by baseline serum LA level (odds ratio = 7.27, 95% confidence interval = 1.11-47.76), indicating that it is a significant risk factor for the development of psychiatric disorder at 6 months. Thus, dietary education to reduce the intake of LA-containing foods might be useful for preventing psychiatric disorder in the population at high risk for ACS. However, the prevalence of psychiatric disorder, particularly depressive disorder, may have been too low to identify significant differences in PUFA analysis.

BACKGROUND: The efficacy of the mindfulness-based stress management program for maintaining a better mental state has not been examined among working populations. We aimed to explore the effectiveness of the brief mindfulness-based stress management program for hospital nurses. METHODS: In a multi-center randomized trial, 80 junior nurses working in hospitals were randomly allocated either to the brief mindfulness-based stress management program or psychoeducation using a leaflet. The program consisted of four 30 min individual sessions conducted by trained senior nurses using a detailed manual. The primary outcome was the total score of the Hospital Anxiety and Depression Scale (HADS) at week 26. Secondary outcomes included presence of a major depressive episode; severity of depression, anxiety, insomnia, burnout, and presenteeism; utility scores; and adverse events up to 52 weeks. RESULTS: The mean HADS score of all the participants at baseline was 7.2. At 26 weeks, adjusted mean scores on the HADS score were 7.2 (95% confidence intervals: 5.9, 8. 5) in the program group and 6.0 (4.8, 7.2) in the leaflet group, respectively. The coefficient of the group by time interaction was not statistically significant at -1.41 (-3.35, 0.54; P = 0.156). No significant superiority or inferiority was observed on the other outcomes. LIMITATIONS: We did not manage to recruit the number of participants we initially set out, although our post-hoc analyses showed that this did not lead to changes in our conclusions. CONCLUSIONS: The additive value of the brief mindfulness-based stress management program was not confirmed in mental state and self-evaluated work efficiency.

BACKGROUND: The pathophysiology of fear of cancer recurrence (FCR), the leading unmet psychological need of cancer survivors, may involve the dysfunctional processing of fear memory. n-3 polyunsaturated fatty acids (PUFAs) have beneficial effects on psychiatric disorders, including depressive disorder and anxiety disorders, and are involved in fear memory processing. We hypothesized that n-3 PUFA composition is associated with FCR in cancer survivors. METHODS: We conducted a cross-sectional study to examine the relationship between n-3 PUFAs and FCR among breast cancer survivors. Adults who had been diagnosed with invasive breast cancer and were not undergoing chemotherapy were asked to participate. Blood PUFA composition was evaluated by using capillary blood. We directly administered the Concerns About Recurrence Scale (CARS) to assess the grade of FCR. RESULTS: Among 126 participants used for the analysis, the mean age (SD) was 58 (11) years and 47% had stage I cancer. Multiple regression analysis controlling for possible confounders, depressive symptoms, and post-traumatic stress disorder (PTSD) symptoms revealed that the alpha-linolenic acid (ALA) level was significantly inversely associated with the average score on the CARS overall fear index (beta = -0.165, p = 0.04). No significant associations were found for other PUFAs. LIMITATIONS: Our findings were obtained from a cross-sectional study in a single institute. CONCLUSION: These findings provide the first evidence of a beneficial effect of ALA on FCR and indicate the need for prospective study of this association. FCR among breast cancer survivors might be controllable by prudent selection of ALA-containing cooking oil.

In contrast to the cumulative evidence suggesting the inverse association of n-3 polyunsaturated fatty acids (PUFAs) with depression, few studies have examined the association of n-6 PUFAs with depression. In particular, no study has examined the relationship between n-6 PUFAs and depression in cancer patients. Thus, we conducted this cross-sectional study to comprehensively examine the association of n-3 and n-6 PUFAs with depressive symptoms in breast cancer survivors. Adults who had been diagnosed with invasive breast cancer and were not undergoing chemotherapy were enrolled. Blood PUFA composition was determined using capillary blood. Depressive symptoms were assessed using the Hospital Anxiety and Depression Scale (HADS). Among 126 participants, the mean age (standard deviation) was 58 (11) years and 47% had stage I cancer. Multiple regression analysis controlling for possible confounders revealed that the level of total n-6 PUFAs and linoleic acid was significantly associated with the HADS total score (beta = 0.175, p = 0.046 for total n-6 PUFAs; beta = 0.174, p = 0.048 for LA). No significant associations were found for other PUFAs. These findings provide the first evidence suggesting that a higher blood level of total n-6 PUFAs and linoleic acid is significantly associated with higher depressive symptoms among breast cancer survivors. Further studies should examine the positive effects of a reduction in n-6 PUFAs on depressive symptoms in breast cancer survivors using prospective studies, including randomized control trials.

The present study attempted to develop a handbook for sexual assault victims during the acute phase and evaluate its utility among support providers. Method：We developed a handbook based on prior research and interviews with sexual assault victims. We revised the draft based on interdisciplinary specialists’ opinions. Handbooks were distributed to support givers who were requested to use them with victims. We distributed self-administered questionnaires to participants comprising support givers to victims of severe sexual assault experiences. Results：Of the 104 survey respondents (55.9% response rate), 95.2% were female and the mean age was 54.1±13.1 years. Overall, 18.3% of the respondents used the handbook to provide victims with support during the survey. More than 80% of the respondents commented that the content was useful for supporters and sexual assault victims. More than 70% reported that the content was easy to understand, 41.3% stated that it contained extensive information, and 10.6% replied that support providers’ burdens increased when victims used the handbook. Discussion：This handbook was utility among a group of support providers. Nonetheless, it is necessary to conduct a detailed examination of its content in the future.