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☐ ☆ ✇ BMJ Open

Feasibility and clinical and implementation effectiveness of an adapted early warning signs and symptoms intervention for the early detection of childhood cancer in Cameroon and Kenya: protocol for a quasi-experimental, hybrid type 2 implementation effect

Por: Noh · H. · Chelva · M. P. · Mbah Afungchwi · G. · Pondy · A. · Githanga · J. · Landis · F. · Kinge · M. · Martiniuk · A. L. · Ward · N. · Barwick · M. · Gupta · S. · Denburg · A. — Septiembre 2nd 2025 at 15:14
Introduction

Childhood cancer accounts for a significant proportion of global childhood mortality, especially in low-income and middle-income countries (LMICs). Unlike many adult malignancies, primary prevention of childhood cancers is not possible. Improving survival requires a two-pronged strategy: earlier diagnosis and effective treatment. Our study aims to establish the feasibility, clinical and implementation effectiveness of an adapted early warning signs and symptoms (EWSS) intervention in Cameroon and Kenya. It will equip healthcare workers, Ministry of Health (MOH) representatives and National Cancer Institute leaders with evidence-informed guidance on implementing context-adapted interventions to improve the early detection and referral of childhood cancers in these countries.

Methods and analysis

The study is a quasi-experimental, hybrid type 2 implementation effectiveness study based on a Ghanaian adaptation of the ‘Saint Siluan’ EWSS campaign. Our protocol proposes context-specific adaptation and evidence-based implementation of the EWSS intervention through iterative engagement with country-level implementation teams to train healthcare workers and improve referral pathways for earlier childhood cancer diagnoses in each study country. Training effectiveness will be measured through pretraining and post-training tests of knowledge and application, as well as training satisfaction surveys. Clinical effectiveness will be assessed by using a REDCap database to track the number of newly diagnosed childhood cancer cases in the study regions and counties, healthcare timelines and paths to diagnosis, and the stage and proportion of metastatic disease at diagnosis. Implementation effectiveness will be evaluated through interviews with senior and mid-level health system partners and clinicians, tracking fidelity to the implementation process as laid out in The Implementation Roadmap Workbook, and analysis of meeting minutes from monthly local implementation team meetings.

Ethics and dissemination

This study has received ethical approval from The Hospital for Sick Children (REB # 1000080092) and all participating sites. We have received National Ethical Clearance from the Cameroon Ethical Board (#1699) and Regional Administrative Authorizations from our piloting regions (Centre and West). We have also received ethical clearance from Kenyatta National Hospital (KNH) (ERB# KNH-ERC/RR/955) and our National Commission for Science, Technology and Innovation in Kenya licence from the counties we are piloting in Kenya. As clinical data will be collected from existing health registries and patient charts, patient consent will not be required; however, we will obtain consent from all members of the leadership implementation teams and operational implementation teams for their participation in the implementation meetings and from all individuals participating in the semistructured interviews. We will disseminate findings to build awareness and share findings among various target audiences: (1) key county and regional parties (eg, clinical societies, advocacy groups, country MOHs and regional bodies such as the East African Community, Economic Community of West African States); (2) international bodies such as the WHO; and (3) the academic community.

☐ ☆ ✇ BMJ Open

Pain management training for people with persistent pain and their informal carers (JOINT SUPPORT): multicentre randomised controlled feasibility trial with embedded qualitative study in English musculoskeletal services

Por: Smith · T. · Khoury · R. · Welsh · A. · Crowther · C. · Hanson · S. · Grant · K. · Clark · A. B. · Ashford · P.-A. · Hammond · M. · Pond · M. · Dures · E. · Adams · J. — Abril 15th 2025 at 18:38
Objectives

To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of a pain management training intervention to support people with persistent musculoskeletal pain and their informal carers.

Design

Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study.

Setting

National Health Service (NHS) providers in four English hospitals.

Participants

Adults receiving NHS care for persistent musculoskeletal pain and their informal carers.

Intervention

Control: usual NHS care. Experimental: usual NHS care plus a carer-patient pain management training intervention (JOINT SUPPORT), comprising five, 1-hour, group-based sessions for patients and carers, delivered by trained physiotherapists or occupational therapists. Content included understanding pain, pacing, graded activity, fear avoidance, goal-setting, understanding the benefits of physical activity and medication management. This was re-enforced with a workbook. After the group-based sessions, patients and carers were supported through three telephone sessions.

Randomisation

Central randomisation was computer-generated (2:1 Experimental:Control), stratified by hospital and patient-participant age (≤65 years). There was no blinding.

Main outcome measures

Data collected at baseline and 3 months post-randomisation included screening logs, intervention logs, fidelity checklists and clinical outcomes on quality of life, physical and emotional outcomes, adverse events and resource use. Interviews with 14 patient-carer participants and six health professionals who delivered the intervention.

Results

A total of 76 participants (38 patients; 38 carers) were enrolled. Sixty per cent (312/480) of patients screened were eligible with 12% consenting to be randomised (38/312). Fifty-four per cent (13/24) of the experimental group reached minimal compliance with the JOINT SUPPORT intervention. There was no evidence of treatment contamination. For patient-participant outcomes, within-group differences from baseline to 3 months favoured the control group when assessed by EQ-5D and Generalised Self-Efficacy total score, but favoured the intervention group when assessed by numerical rating scale pain, fatigue and Centre for Epidemiologic Studies Depression Scaletotal score. Qualitative data demonstrated the acceptability of the trial design and JOINT SUPPORT intervention with modifications to improve trial processes.

Conclusions

The JOINT SUPPORT intervention was acceptable to patient-carer dyads and health professionals. Modifications to trial design, particularly enhanced recruitment strategies, are required.

Trial registration number

ISRCTN78169443.

Data availability statement

The data that support the findings of this study are available from the corresponding author (TS) on reasonable request. This includes access to the full protocol, anonymised participant-level dataset and statistical code.

☐ ☆ ✇ BMJ Open

Randomised controlled trial of a nurse coordination intervention for people living with dementia and their carers: study protocol

Por: Carey · M. L. · Kelly · M. · Pond · D. · Nair · B. R. · Attia · J. · Jeon · Y.-H. · Deeming · S. · Rhee · J. J. · Wales · K. · Khaing · K. · Williams · A. · White · J. · Harden · M. · Ford · C. · Ward · J. · Lithgow · S. · Oldmeadow · C. · Jalewa · J. · Smart · E. · Wood · K. · Bartczak · A. · F — Abril 15th 2025 at 18:38
Introduction

The multifaceted impact of dementia means that people living with dementia require multidisciplinary care across different services and settings; however, these care transitions pose a risk of fragmented care. Models that improve integration and coordination of care in the community are needed.

Methods and analysis

This randomised control trial will test the effectiveness and cost effectiveness of a dementia nurse-led intervention to: (1) increase days lived in the community at 12-month follow-up (primary outcome) among people living with dementia and (2) improve quality of life for people living with dementia and their carers, compared with usual care. Participants are recruited from several sources including private and public geriatric medicine clinics, carer support groups and self-referral. People living with dementia and their carers are randomised as a dyad to (1) usual care or (2) dementia nurse-led care-coordination. The dementia nurse will provide care coordination and direct support through a tailored, integrated and patient-centred approach. The needs of people living with dementia will be identified and addressed, with a focus on improving the management of comorbidities, risk reduction and symptoms. Carers will also receive support. The model for people living with dementia will focus on days lived in their community as the outcome variable. Differences between groups in quality of life at 12-month follow-up will be assessed using linear mixed effects regression. Analysis will follow the intention to treat principles. People living with dementia and carers’ data will be analysed separately and collectively for the economic study.

Ethics and dissemination

The trial has been approved by the Hunter New England Research Ethics Committee (2023/ETH01221) and the University of Newcastle Ethics Committee (R-2024–0021). Trial findings will be disseminated via peer-reviewed publications and conference presentations. If the intervention is effective, the research team aims to further implement the intervention as usual care within the participating services and beyond.

Trial registration number

The trial was prospectively registered via the Australian New Zealand Clinical Trials Registry: ACTRN12624000235505. Registration date: 11 March 2024.

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