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Individualised dosimetry for holmium-166 RE in patients with unresectable hepatocellular carcinoma; a multi-centre, interventional, non-randomised, non-comparative, open label, phase II study: RHEPaiR

Por: Qurashi · M. · Martinez · M. · Ward · C. · Wyard · C. · Izadi · H. · Bowen · C. · Khan · S. R. · Tait · P. · Smits · M. · de Bruijne · J. · Thomas · R. · Lam · M. G. E. H. · Sharma · R.
Introduction

Radioembolisation (RE) is gaining traction as a robust treatment option for patients with hepatocellular cancer (HCC) across all cancer stages. RE allows the delivery of targeted high-dose radiation directly to tumours, with relative sparing of the surrounding liver tissue. Traditionally, radiation has been delivered using 90Yttrium ([90Y]Y)-labelled microspheres, either glass or resin. The success of RE is dependent on the dose delivered to the tumour. When using [90Y]Y microspheres, dose prediction is calculated through a 99mTechnitium ([99mTc]Tc)-macroaggregated albumin (MAA) scan, which allows the calculation of the dose to be administered to the tumour. However, [99mTc]Tc-MAA is not a true surrogate of [90Y]Y microspheres, and this will impact on the final dose delivered. [166Ho]Ho, like [90Y]Y, is a beta emitter but unlike [90Y]Y also emits gamma-radiation, allowing for quantitative nuclear imaging. The primary aim of this pilot study was to investigate the safety and efficacy of dosimetry-based individualised 166Holmium ([166Ho]Ho-RE) in patients with HCC.

Methods and analysis

15 eligible participants will be recruited to receive [166Ho]Ho-RE. The primary objective is to establish the toxicity profile of dosimetry-based individualised [166Ho]Ho-RE. The secondary objective is to assess efficacy as measured by modified Response Evaluation Criteria in Solid Tumours (mRECIST) and Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria. Additional exploratory objectives include quality of life assessment and identification of a radiomic signature of response. The results from this study will be combined with the prospective iHEPAR study to form a larger analysis.

Ethics and dissemination

The study has received approval from the East Midlands—Nottingham 1 Research Ethics Committee—approval number 23/EM/0239. The study will be performed in compliance with the Declaration of Helsinki and the principles of Good Clinical Practice. Signed informed consent will be obtained from each patient before study entry. The results will be disseminated through publication in a peer-reviewed scientific journal.

Trial registration number

Clinicaltrials.gov NCT06302400.

Psychosocial interventions for diabetes distress in culturally diverse populations: a systematic scoping review

Por: Weerasinghe · S. A. · Wang · G. · Izadikhah · Z. · Goh · Y. · Ireland · M. J.
Objectives

Diabetes distress, arising from the relentless demands of diabetes management, is notably higher in culturally diverse groups. Psychosocial interventions may reduce diabetes distress through cultural tailoring that addresses beliefs and language barriers. This scoping review aimed to map the availability, key features and impact of psychosocial interventions addressing diabetes distress in culturally diverse groups.

Design

This scoping review followed the Arksey and O’Malley framework.

Data sources

Five databases (PubMed, PsycINFO, Cochrane Library, CINAHL and Web of Science) were searched for peer-reviewed publications (2013–2024).

Eligibility criteria

The included studies involved participants from culturally diverse groups who were diagnosed with diabetes and engaged in psychosocial interventions. Our search did not restrict diabetes type, but all included studies enrolled adults with type 2 diabetes. Studies in English, with no restrictions on study design and geographical location were included. The review excluded studies focusing on caregivers of patients with diabetes, healthcare providers, Native and Indigenous groups, and lifestyle interventions focused on physiological outcomes.

Data extraction and synthesis

Study characteristics, participant demographics, intervention features and outcomes (including participant satisfaction and attrition) were extracted and synthesised thematically by intervention type. Findings are presented narratively.

Results

The review included 13 studies. All psychosocial interventions included diabetes education alongside psychosocial strategies, with most being short-term (four months or less) and delivered in person. Small to moderate reductions in diabetes distress were observed in all but three studies. Empowerment-based interventions produced short-term reductions; longer interventions showed more gradual change. These interventions also improved knowledge of diabetes management, self-efficacy, self-management behaviours and social support. In contrast, peer-led interventions showed limited effectiveness in improving psychosocial outcomes. Mixed evidence was found for the value of family-based interventions.

Conclusion

This review recommends the integration of psychosocial interventions into healthcare plans and highlights several gaps in the evidence base, including limited cultural adaptations beyond linguistic modifications, and a limited focus on South Asian and Middle Eastern populations. Future research should consider multi-site RCTs, longitudinal designs and refinement of intervention designs to improve accessibility, cultural relevance, and sustainability over time.

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