Burnout and reduced well-being are highly prevalent among Japanese medical students during clinical training. Scalable, evidence-based interventions are urgently needed. This protocol outlines a nationwide randomised controlled trial (RCT) to evaluate a self-guided, on-demand Acceptance and Commitment Training (ACT) programme for reducing burnout and improving well-being during clinical clerkships.

This two-arm, open-label, parallel-group RCT will recruit 128 Japanese medical students in clinical clerkships, randomised to on-demand ACT or no-intervention control. The ACT intervention comprises three self-guided online modules at weeks 0, 2 and 4, plus a 30 min online booster (weeks 8–10). Self-reported outcomes are measured at baseline, mid-intervention, postintervention and at 14-week primary endpoint (week 14). The primary outcome is medical student burnout (Oldenburg Burnout Inventory for Medical Students). Secondary outcomes include well-being (Mental Health Continuum-Short Form), professional burnout (Maslach Burnout Inventory–Human Service Survey), psychological flexibility (Work-related Acceptance and Action Questionnaire, Valuing Questionnaire), depressive symptoms (Patient Health Questionnaire-9), mental illness stigma (Mental Illness: Clinicians’ Attitudes Scale version 4), ACT process knowledge (ACT Check, applied section); adverse events and serious adverse events and adherence (platform completion and engagement metrics), all assessed at prespecified time points. Data will be analysed using mixed-effects models for repeated measures on an intention-to-treat basis.

This protocol was approved by the Nagoya City University Clinical Research Review Board (No. 70-22-0022) and registered with the Japan Registry of Clinical Trials (jRCT1042250024). Results will be disseminated via publications and conference presentations.

jRCT1042250024.

Shared decision-making (SDM) requires that individuals are correctly and smoothly supported to make decisions. However, in Japan, development of decision aids (DAs) to support implementation of SDM is lagging behind Western countries, and there are few reports focused on breast reconstruction. Thus, it is unclear if SDM using a DA in the context of the unique national character and medical culture in Japan is useful in decision-making for breast reconstruction, including whether or not to undergo reconstruction. The aim of this multicentre collaborative study is to investigate the clinical effectiveness of SDM using a DA for patients with breast cancer considering reconstruction, from the perspectives of decisional conflict and postoperative quality of life.

A multisite trial will be conducted at 12 facilities certified by the Japanese Society of Breast Oncoplastic Surgery. A cluster-randomised controlled trial is planned at centres that have implemented SDM with DAs and those that have not implemented SDM, but use a conventional surgical explanation and informed consent to make decisions about reconstruction methods. The study participants will be female patients aged ≥20 years with newly diagnosed stage 0–III breast cancer who are interested in breast reconstruction. Data collection includes baseline and follow-up patient surveys and medical record review. The effectiveness of the DA at reducing conflict and regret in decision-making (primary outcome) will be evaluated using the decision conflict scale.

This protocol has been approved by the Kyoto University Central Institutional Review Board, and permission for performance of the study has been obtained from the Ethics Review Board at each participating centre. We plan to disseminate the findings through journal publications and national meetings, including a presentation of the research results at the Japanese Society of Breast Oncoplastic Surgery. Our findings will advance the science of medical decision-making and have the potential to reduce socioeconomic health disparities.

UMIN000052161.

Ischaemic heart disease (IHD) is a leading cause of morbidity and mortality worldwide. Despite strong recommendations, the implementation rate of outpatient cardiac rehabilitation (CR) in Japan remains low. Mobile health technologies, such as Personal Health Record (PHR) applications combined with wearable devices, may enhance adherence to rehabilitation programmes. This study aims to evaluate the effectiveness of a continuous support programme that integrates a PHR app and counselling services in improving the continuation rate of outpatient CR and exercise tolerance in patients with IHD.

This is a single-blind randomised controlled trial with a parallel-group design. A total of 72 participants with IHD will be recruited from the outpatient departments of Maebashi Red Cross Hospital, Gunma Saiseikai Maebashi Hospital, Okayama University Hospital, Okayama Red Cross Hospital, Momoyama-kai Ono Internal Clinic, Hiroshima University Hospital, Tshuyama Jifu-kai Tsuyama Chuo Hospital and Shinpu-kai Tamashima Chuo Hospital. Participants will be randomly allocated to either the intervention group, which will receive a wearable device, a PHR app, counselling services and a rehabilitation notebook, or the control group, which will receive a wearable device and a rehabilitation notebook without the PHR app and counselling. The primary outcome is the change in peak oxygen uptake from baseline to 150 days. Secondary outcomes include changes in anaerobic threshold, number of outpatient rehabilitation visits, daily steps and vital signs. Data will be analysed using a generalised estimating equations for primary outcomes and appropriate statistical tests for secondary outcomes, following an intention-to-treat approach.

Ethical approval for this study was obtained from the ethics committee of the Kyoto University Graduate School and Faculty of Medicine (C1669-1). In addition, permission to conduct the study was granted by the director of each participating institution. Participants will provide informed consent prior to participation. Findings will be disseminated through peer-reviewed journals, conferences and summary reports to stakeholders.

This trial is registered with the University hospital Medical Information Network (UMIN) Clinical Trials Registry (trial identifier: UMIN000055823).