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Feasibility of a mobile application-based geriatric assessment and communication support intervention for older adults with cancer: protocol for a pilot randomised controlled trial (MAPLE2 pilot)

Por: Matsuoka · A. · Konishi · Y. · Boku · N. · Takashima · A. · Okusaka · T. · Mori · K. · Akechi · T. · Tsubata · Y. · Majima · Y. · Uchitomi · Y. · Nagashima · F. · Fujimori · M.
Introduction

Older adults with cancer have ageing-related vulnerabilities that influence their treatment tolerance and decision-making. In our previous randomised controlled trial (MAPLE), integrating geriatric assessment (GA) with communication support using a question prompt list (QPL), delivered by trained intervention providers, facilitated patient–oncologist communication, increased implementation of GA-guided management (GAM) and improved patient outcomes. However, its widespread adoption has been limited by the need for trained personnel and dedicated time. To enhance scalability and sustainability, we developed a mobile application-based intervention to deliver GAM and communication support. This MAPLE2 study aims to evaluate the feasibility of the intervention using this mobile application-based GA and QPL among older adults with cancer.

Methods and analysis

This multicentre, open-label, pilot randomised controlled trial will be conducted at two academic hospitals in Japan. Patients aged≥70 years with solid cancer or lymphoma initiating or changing systemic therapy will undergo baseline GA. Patients with any GA impairment will be randomised to receive either (1) a mobile application-based intervention providing feedback of GA summary with tailored GAM recommendations and QPL or (2) usual care. The primary endpoint is the proportion of participants who complete all of the following interventions using the mobile application: (1) self-administered GA, (2) receipt of the tailored GAM recommendations and QPL and (3) confirmation that their oncologists review the tailored GAM recommendations and QPL at subsequent visits. Forty participants are planned to be enrolled.

Ethics and dissemination

The study has been approved by the Institutional Review Board of the National Cancer Center, Japan (approval number: 2025-089). Written informed consent will be obtained from all participants. Results will be presented at academic conferences and published in peer-reviewed journals.

Trial status

Recruitment has been initiated from 8 September 2025 and is planned to be completed by 31 August 2026, with a follow-up period by 31 August 2027.

Trial registration number

UMIN000058887

Triple-drug therapy with Goreisan, tranexamic acid and carbazochrome sodium sulfonate hydrate to prevent recurrence after chronic subdural haematoma surgery: a multicentre, randomised, controlled trial protocol

Por: Negishi · H. · Hirata · K. · Aiyama · H. · Fujita · K. · Komatsu · Y. · Kato · N. · Shibata · Y. · Tsuda · K. · Yamazaki · T. · Sato · M. · Watanabe · S. · Sugii · N. · Konishi · T. · Mathis · B. J. · Ohigashi · T. · Endo · M. · Ishikawa · E. · Matsumaru · Y. · The Triple Study Investigato
Introduction

Chronic subdural haematoma (CSDH) is a common neurosurgical condition in older adults, with a recurrence rate of approximately 7.1–13% after burr-hole drainage. Although surgical adjuncts such as subdural drains and middle meningeal artery embolisation may reduce recurrence, these are not suitable for all patients. Pharmacological strategies, including tranexamic acid, Goreisan and carbazochrome sodium sulfonate hydrate, have shown potential, but high-level evidence remains lacking. A prior retrospective study suggested that a triple oral regimen combining these agents may reduce recurrence. This randomised controlled trial aims to evaluate its efficacy and safety.

Methods and analysis

This is a prospective, multicentre, open-label, randomised controlled trial conducted across six hospitals in Ibaraki, Japan. A total of 180 patients undergoing first-time burr-hole surgery for CSDH will be randomised 1:1 to receive either triple therapy (Goreisan 7.5 g/day, carbazochrome sodium sulfonate hydrate 90 mg/day and tranexamic acid 750 mg/day for up to 90 days) or standard postoperative care. The primary outcome is recurrence requiring reoperation within 90 days. Secondary outcomes include time to recurrence and haematoma volume reduction on serial CT imaging. All analyses will follow the intention-to-treat principle, using logistic regression, Cox proportional hazards models and mixed-effects models.

Ethics and dissemination

Written, informed consent will be obtained from all participants at each participating hospital by trained staff from that hospital. The trial protocol has been approved by the ethics committee of the University of Tsukuba Hospital (approval no. TCRB23-025) and the Institutional Review Boards of all participating centres. Study findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals. A summary of the results will also be provided to participating institutions and made publicly available in accordance with the BMJ Open data sharing policy.

Trial registration number

jRCTs031240007.

Exploring Health Care Needs and HR‐QOL Among Women With Cancer: A Principal Component Analysis Before and 6 Months After Treatment Initiation

ABSTRACT

Aim

To examine the characteristics of the health care needs corresponding to the medical care process and HR-QOL of women with cancer.

Design

A descriptive design was adopted.

Methods

The study's participants were 122 women with cancer who completed a survey before and 6 months after treatment initiation. A principal component analysis (PCA) was conducted on a set of 12 health care satisfaction scores at each point. Correlations were examined between the resulting components and HR-QOL indicators, including subjective well-being, symptoms, symptom-related interference, anxiety and depression.

Results

Most participants reported high health care satisfaction in both phases. PCA indicated the presence of 3 distinct domains: satisfaction with health care, health care management and supportive care. In both phases, these domains accounted for about 60% of the variance, while the remaining 40% was unexplained. Only satisfaction with health care was correlated with HR-QOL at both phases, with particularly strong associations observed for subjective well-being and depression at 6 months. Before treatment initiation, the item of ‘nursing care and practice’ received the highest average score, but demonstrated a negative loading on the component of ‘satisfaction with health care management’. The component of ‘satisfaction with supportive care needs’ was retained at both phases.

Conclusion

Health care plays a pivotal role in maintaining patients' quality of life, while supportive care and the integration of nursing practice within health care management remain essential.

Implications for Patient Care

High satisfaction scores do not necessarily mean that all health care needs are met. Addressing unmet needs from the perspective of HR-QOL and ensuring continuous supportive care throughout the treatment process is imperative.

Patient Contribution

Data provided by women with cancer was used.

Effectiveness of exercise therapy in patients with knee osteoarthritis: an overview of systematic reviews

Por: Kitagawa · T. · Isaji · Y. · Sasaki · D. · Onishi · K. · Hayashi · M. · Okuyama · W.
Objective

This study aimed to assess the methodological quality of published systematic reviews of exercise therapy in knee osteoarthritis and summarise their reported effectiveness on quality of life, knee joint function, or adverse events.

Design

Overview of systematic reviews.

Data sources

PubMed, Embase, CINAHL, Web of Science and CENTRAL (searched on 14 April 2025), plus grey literature (PROSPERO, Epistemonikos, OpenGrey).

Eligibility criteria for selecting studies

We included systematic reviews of randomised controlled trials in patients diagnosed with knee osteoarthritis by imaging or clinical criteria and treated conservatively with exercise therapy; we excluded reviews that enrolled patients scheduled for surgery, with acute inflammation or osteoarthritis of other joints (hand, hip, ankle), for which relevant author data could not be obtained after one contact attempt, or that did not report at least one primary outcome (quality of life, knee joint function or adverse events).

Data extraction and synthesis

Two reviewers independently extracted data on study characteristics, interventions and outcomes, and assessed methodological quality using the AMSTAR 2 (A MeaSurement Tool to Assess systematic Reviews 2) tool. Due to heterogeneity in outcome measures across systematic reviews, meta-analysis was not conducted. Effectiveness was defined as any reported beneficial outcome of exercise therapy on predefined outcomes, including quality of life, physical function, pain or adverse events.

Results

58 systematic reviews were selected. Muscle-strengthening (74.1%) and aerobic (48.2%) exercises were the most commonly prescribed exercise-based interventions. SF-36 (36-Item Short Form Health Survey) and the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) were the most popular outcome-evaluation tools. Furthermore, 63.7% of the systematic reviews revealed that exercise therapy improved all outcomes. The number of intervention-related adverse events was small. Notably, almost all systematic reviews (87.4%) had a critically low quality.

Conclusions

Current evidence on exercise therapy for knee osteoarthritis is inadequate. Nevertheless, exercise therapy can be considered for conservative treatment of knee osteoarthritis. Future studies should use network meta-analyses to compare the effects of different exercise therapies and determine their superiority over other conservative therapies.

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