Patient falls in hospitals lead to patient harm, staff distress and economic burden on health systems. There are few strategies with robust evidence demonstrating benefit for the prevention of falls, especially in acute hospital settings. Education and multicomponent fall prevention approaches are promising. Rigorous systematic measurement of implementation has been lacking in most hospital fall prevention trials. This paper describes the protocol for a trial that will evaluate the impact of supported implementation of tailored multicomponent fall prevention interventions on patient falls in hospital.

A stepped-wedge hybrid type I effectiveness implementation cluster randomised trial will be conducted. Twelve inpatient wards across four metropolitan hospitals will be enrolled in the trial, clustered into groups of four and randomised to commence the intervention at one of three time periods. Patients and ward staff will be recruited to complete pre-implementation surveys, which, combined with analysis of routinely collected local falls data and staff brainstorming, will inform tailored multicomponent fall prevention interventions for each ward. Wards will receive quality improvement training, clinical facilitation and staff education for at least 4 months to support implementation of their fall prevention interventions. The primary outcome—rate of falls—will be measured using routinely collected hospital falls data from the incident management system and medical records. Pre-implementation and post-implementation patient and staff surveys, qualitative interviews and bedside audits will measure secondary effectiveness and implementation outcomes. Healthcare utilisation from hospital data will inform the cost-effectiveness analysis.

The Sydney Local Health District Human Research Ethics Committee (RPAH Zone) approved this trial (protocol number X24-0087 and 2024/ETH00583). The trial is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12624000896572). Data collection commenced in October 2024, due for completion in May 2026. Results will be published in reputable international journals and presented at relevant conferences.

Australian and New Zealand Clinical Trials Registry (ACTRN12624000896572).

Debilitating Symptom Complexes Attributed to Ticks (DSCATT) is a new term for an unexplained Australian syndrome—people who suffer from a chronic, multifaceted and debilitating illness, characteristically attributed to tick bites, but in a country without endemic Lyme disease. Despite the profound morbidity of DSCATT, no single causative agent has been identified and there are no recognised treatments for the illness at present. An increasing body of evidence shows psychological therapies such as Acceptance and Commitment Therapy (ACT) can be effective in reducing symptom-related disability and improving quality of life for other unexplained syndromes. Here we present a study protocol to assess the feasibility of an ACT-informed intervention for patients suffering from DSCATT, to be used adjunctively to their pre-existing healthcare. The study aims to assess the acceptability, practicality and demand for the treatment. Additionally, we will examine the effects of therapy on participants’ health and well-being, its safety, potential mediators of response to therapy and its preliminary cost-effectiveness.

We will assess the feasibility of a 32-week, randomised, waitlist-controlled, parallel convergent mixed-methods pilot trial for DSCATT. Participants will be randomised in a 1:1 ratio to receive either 16 sessions of ACT-informed therapy adjunctive to their pre-existing healthcare, delivered one-to-one with a trial therapist within a 20-week period or be assigned to the waitlist control group where they will continue their treatments as usual. We will collect quantitative and qualitative data to address study aims, with retention rate being the primary feasibility outcome.

The study has ethical approval from Austin Health Human Research Ethics Committee (HREC). The outcomes will be published in peer-reviewed journals. Data from participants who have given extended consent will be available for other HREC-approved studies.

ACTRN12623000372684, prospectively registered 13 April 2023, URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=385579&isReview=true; the last participant is expected to complete in November 2026.

Adults living with chronic conditions may need to access health programmes to mitigate health-related challenges that persist long after discharge from the hospital. Community physical activity programmes represent critical opportunities for health promotion and chronic disease self-management that can extend beyond hospital-based services. However, navigating the healthcare system and connecting to much-needed physical activity programmes can be challenging due to fragmentation of the health and social care system, especially for those who are transitioning between different healthcare providers, settings, stages of recovery and funding sources (eg, public, private). Patient navigation services can assist with this fragmentation by providing tailored support to individuals with chronic conditions. However, our understanding of patient navigation services in Canada is limited. This rapid review seeks to explore the landscape of patient navigation services supporting Canadians with chronic conditions in connecting to physical activity programmes in the community.

The rapid review will follow the recommendations published by Garritty et al in 2024. Integrated Knowledge Translation will be employed to facilitate meaningful engagement of people with lived experience of chronic conditions throughout the entire research process. Studies published in English that examine patient navigation services in physical activity for community-dwelling Canadians with chronic conditions will be included. Ovid MEDLINE, Embase, Emcare, CINAHL and Google Canada will be searched for articles published from 1990 to May 2025 to identify the characteristics, strengths and limitations, and prioritised features of patient navigation services for community physical activity programmes. The Mixed Methods Appraisal Tool will be used to assess the quality of included studies.

This protocol is a rapid review of published literature and does not require ethical approval. Review findings will be disseminated to various key interest groups through publications, presentations, infographics, social media posts and/or videos.

https://osf.io/gd2zm.

Urgent and emergency care (UEC) systems in England face unprecedented pressures, with record accident and emergency attendances, persistent breaches of ambulance response targets and poorer outcomes for time-sensitive conditions. National UEC recovery plans have introduced multiple innovations—such as same-day emergency care, virtual wards and specialty hubs—to manage these pressures and improve patient flow. Rural coastal areas are particularly vulnerable to excessive demand due to higher levels of deprivation, older populations with complex health needs, seasonal surges that generate unpredictable demand and challenges in attracting and retaining staff. Following the Chief Medical Officer’s 2021 Annual Report, funding research and developing bespoke solutions to manage UEC demand and address geographical disparities has been recognised as a national priority. The Elevate study responds to this priority by identifying and evaluating innovative models of UEC in rural coastal communities in England.

The Elevate study is a 30-month, mixed-methods evaluation that comprises three interlinked work packages: (1) National service mapping—outlining provision of innovative models of UEC in rural coastal areas of England. This will be developed through document review and interviews with regional and national service leaders. (2) Quantitative analysis—quasiexperimental and longitudinal approaches will use National Health Service (NHS) England’s Emergency Care Data Set and linked routine NHS datasets to evaluate the impact of UEC models on health and process outcomes. Standard and bespoke metrics will be developed and used to assess performance. (3) Qualitative case studies—up to 12 case studies of UEC models in rural coastal communities. Interviews with patients and staff and non-participant observation will explore how and why different UEC models influence patient experience, clinical outcomes, resource use and the workforce. Findings will be integrated using the Consolidated Framework for Implementation Research to identify components of UEC models that are effective, scalable and sensitive to local context,

Ethical approval for qualitative components was granted by the North of Scotland Research Ethics Committee (25/NS/0099). Dissemination will include peer-reviewed publications, policy briefs, creative media and community engagement activities to ensure findings are communicated inclusively and effectively to policymakers, health and social care practitioners and the public.

Research Registry (researchregistry11126).

The Circle of Security-Parenting (COS-P) group intervention has demonstrated efficacy in reducing maternal perinatal mental health difficulty (PMHD) symptoms in some contexts. The Circle of Security Intervention (COSI) study, a multisite, individually randomised, single-blind, parallel-arm controlled trial, was conducted in England to assess the clinical effectiveness of COS-P in reducing perinatal psychopathology, parenting and infant development, as well as its acceptability among the National Health Service (NHS) participants and staff. The main aim of this work is to estimate the cost-utility of COS-P plus treatment as usual (TAU) relative to TAU among mothers and birthing parents receiving NHS perinatal mental health services (PMHS) in England.

A within-trial economic evaluation was performed comparing COS-P plus TAU with TAU alone, using data from the COSI trial, which employed a 2:1 randomisation ratio. Analyses were conducted from both NHS and personal social services (PSS) and societal perspectives. A 12-month time horizon was used, consistent with the final trial follow-up.

Secondary care NHS perinatal health services across multiple centres in England.

A total of 371 mothers and birthing parents with PMHD were randomised and had complete economic outcome data; 248 received COS-P plus TAU and 123 received TAU alone. Participants were eligible if they were receiving NHS PMHS; exclusion criteria were defined in the trial protocol.

Participants in the intervention arm received the COS-P group programme in addition to TAU. The control group received TAU alone.

The primary economic outcome was quality-adjusted life years (QALYs) over 12 months, derived from the 5-level EuroQol five-dimensional (EQ-5D-5L) questionnaire - responses. Costs were estimated from NHS and PSS as well as societal perspectives, including healthcare utilisation and productivity losses due to work absence.

Compared with TAU, COS-P was associated with higher costs from both NHS and PSS (£180.58; 95% CI –£1075 to £1436) and societal (£72.94; 95% CI –£1473 to £1619) perspectives. COS-P was marginally less effective in terms of QALYs (–0.01; 95% CI –0.06 to 0.05). Probabilistic sensitivity analyses indicated substantial uncertainty around cost and effectiveness estimates.

On average, COS-P was associated with higher costs and did not demonstrate improvements in health-related quality of life compared with TAU alone. Given the uncertainty surrounding the estimates, further research is warranted to explore potential longer term economic and clinical impacts of COS-P in perinatal mental health settings.

SRCTN18308962.

Increased risks and concerns regarding patient safety in early-phase studies exist because knowledge about the new intervention is still accumulating. This means that narrow eligibility criteria are needed. However, if early-phase studies are narrow in their inclusion, for example, by not including diverse populations, there is a potential risk that new therapies have insufficient relevant efficacy and safety data. Existing research has explored equity, diversity and inclusion (EDI) factors in early-phase pharmaceutical studies, but it has not been possible to find studies that have systematically examined whether EDI factors have been considered in surgical studies reporting innovative procedures. We aim to examine how EDI factors are considered in early-phase surgical studies and surgical innovation reports to explore how this may impact on later-phase evaluation and inclusive intervention implementation.

A scoping review following the JBI (Joanna Briggs Institute) and Arksey and O’Malley’s five-step process is being conducted. We will search Scopus, PubMed and Web of Science for surgical early-phase studies. A two-step screening process for eligibility is being used. Independent double screening will take place for 20% of the papers. Eligible articles will report early evaluation of an innovative surgical/invasive procedure. Excluded will be comparative and later-phase studies and early evaluations of pharmaceutical products even in a surgical setting. Data on article details, patient eligibility and whether protected characteristics are reported and considered will be extracted. Information about EDI considerations reported in the introduction or discussion of the papers will also be extracted. Findings will be discussed with a patient advisory group. A content synthesis approach will be undertaken and descriptive summaries presented.

This study does not require ethical approval being a secondary analysis. The findings will be disseminated through academic journal publications and oral presentations.

Recent advances in treatment and care have improved survival rates for children and young adults with severe blood disorders such as sickle cell disease (SCD), transfusion-dependent beta-thalassaemia (TDT) and acute leukaemia. However, their quality of life and reproductive and psychosocial outcomes are not yet well studied. For SCD and TDT, robust survival data are mainly limited to North America. Thus, there is a need to fill these knowledge gaps to guide improvements in care, address unmet clinical needs and rigorously assess the efficacy of emerging novel therapies.

This is an observational population-based mixed-methods study of individuals diagnosed with SCD, TDT or acute leukaemia when under the age of 18 in England, involving a data linkage component and a patient-reported outcomes measures survey. Data linkage-eligible participants will be identified from national and regional databases, including the Hospital Episode Statistics, Yorkshire Specialist Register of Cancer in Children & Young People and the National Congenital Anomaly and Rare Diseases Registration Service. Data linkage will be processed within the NHS England and the University of Leeds’ secure, trusted research environments. Data will be accessed without consent under section 251 and approval by the confidentiality advisory group. It will assess survival rates for SCD and TDT as well as clinical, educational and mental health outcomes for SCD, TDT and acute leukaemia diagnosed in childhood.

Survey-eligible participants for SCD, TDT and acute leukaemia cohorts will be checked for their suitability to participate by the North of England clinical care teams. An NHS-approved survey provider will facilitate data checks with the NHS National Data Opt-Out Service. Consent is required for participation in the survey and for subsequent data linkage to existing databases. Surveys are conducted in various formats (online, paper and phone), with reminders sent after 21 days. The survey will assess quality of life and psychosocial and reproductive outcomes. Participants can withdraw at any time, and support is available via telephone helplines.

The study has received ethical and information governance approval from the Health Research Authority (Reference 24/YH/0186) and the Confidentiality Advisory Group (CAG 24/CAG/0138) to process identifiable data without consent. Study results will be available to patients, physicians, researchers, stakeholders and others through open-access publishing, results sharing via media platforms and presentations at conferences and meetings.

Waiting for cardiac surgery is a stressful life event for most patients. Exploring what people experience while waiting and understanding their preferences and views on how waiting time could be improved will help to inform new strategies for more efficacious waiting list management. In this study, we explored experiences and views of people waiting for elective cardiac surgery across four major London hospitals.

Mixed-methods cross-sectional survey, with explanatory concurrent design.

Four cardiac surgery services across two National Health Service Trusts in London.

Patients on waiting lists for elective cardiac surgery at Royal Brompton, Harefield, St Thomas and King’s College hospitals between October 2023 and March 2024.

Experience of waiting for surgery, and preferences about how waiting time could be improved.

554 out of 1041 invited participants agreed to participate (recruitment rate 53.2%). Among them, 274 fully completed the survey (completion rate 49.5%). Most participants (from 52.2% to 70.9%) reported their daily and social activities were impacted by their cardiac condition, and worrying was an ubiquitous feeling (reported by 86%). Psychological distress was reported differently across women and men (higher in women). Eight themes were identified: worrying, daily activities, family/friends and social activities, sexual life, waiting list experience and feelings, communication, most important factors for surgery and suggested improvements. Communication with the surgeon and clinical team, and regular updates on waiting list progress are suggested as crucial factors to alleviate stress, thus potentially improving the experience of waiting for the surgery.

This study highlights the importance of emotional support, clear communication, regular updates on waiting list progress and building trust with the clinical team to improve patient-centred care while waiting for elective cardiac surgery. This finding can offer valuable insights for managing waiting lists in other surgery waiting list contexts.

NCT05996640.

The carbon footprint of end-to-end healthcare deliveries by the National Health Service in England totalled 25.0 megatons of carbon dioxide equivalent (CO₂e) in 2019. Optimal and sustainable healthcare can lead to better health outcomes as well as a lower environmental footprint.

To evaluate the potential impact of prevention and effective management of type 2 diabetes mellitus (T2DM) in adults on both the clinical outcomes and greenhouse gas (GHG) emissions in the UK healthcare setting.

We incorporated an environmental module into the existing IQVIA core diabetes model to estimate the impact of improving clinical outcomes on GHG emissions over a lifetime horizon. We assessed two hypothetical scenarios: (1) preventing progression from pre-diabetes to T2DM through diet and exercise versus no intervention and natural disease progression to T2DM; and (2) well-controlled T2DM using interventions with clinical benefit on glycosylated haemoglobin (HbA1c), and renal and cardiovascular outcomes versus uncontrolled T2DM.

Preventing progression to T2DM led to 6.357 additional undiscounted life years and 67% less kg CO₂e emissions compared with subsequent natural progression to T2DM for a person with pre-diabetes over a lifetime (emissions of 9586 kg CO₂e over 37.115 years vs 28 716 kg CO₂e over 30.758 years, respectively). Well-controlled T2DM led to 1.947 additional undiscounted life years and 21% less kg CO₂e emissions per patient over a lifetime compared with uncontrolled T2DM (emissions of 14 545 kg CO₂e over 22.772 years vs 18 516 kg CO₂e over 20.825 years, respectively). In both scenarios, the GHG emission savings were primarily due to reduced emissions related to avoidance of treating complications of T2DM including cardiovascular, renal and eye diseases.

Effective prevention and management of T2DM through implementation of evidence-based clinical guidelines can improve patient outcomes while reducing the healthcare-related environmental impacts.

Sleep impairments are prevalent among individuals recovering from substance use disorders (SUDs) and are associated with poorer treatment outcomes and increased relapse risk. Physical activity (PA) is known to enhance sleep in general populations, but its day-to-day effects on sleep during SUD recovery remain underexplored, especially across different recovery stages.

In this observational n-of-1 study, we aim to examine within-person associations between daily PA and sleep quality in three groups of individuals at varying stages of substance use recovery (early treatment, continuing care and long-term recovery). A substudy will validate the agreement between two wearable sleep-monitoring devices. A total of 90 participants (30 per recovery group) from Western Australia will complete daily ecological momentary assessments and wear the SENS Motion sensor and/or Withings Sleep Analyzer over a 30-day period. Outcomes include device-derived sleep and PA measures, self-reported affect, craving, well-being and recovery outcomes. Multilevel models will explore within-person and between-person associations. This study will generate individualised evidence on associations between PA and sleep to inform tailored SUD care. It will also assess the feasibility of using wearable sleep monitors in real-world SUD recovery settings. Results may support the future development of just-in-time adaptive intervention procedures.

The study was approved by the Human Research Ethics Committee of Curtin University (HRE2025-0379). Findings will be shared through peer-reviewed publications and conference presentations, with lay summaries provided to treatment facilities and interested participants to support translation into community and service settings.

ACTRN12625000835448.

Peripheral arterial disease (PAD) commonly coexists with chronic kidney disease (CKD). Patients with symptomatic PAD often require endovascular revascularisation to relieve pain or salvage limbs. However, the iodinated intra-arterial contrast routinely used in these procedures is nephrotoxic, placing patients with CKD at increased risk of acute kidney injury (AKI) and long-term renal decline. Carbon dioxide (CO₂) delivered via automated injection is a potential alternative imaging contrast medium. This trial will evaluate whether using CO₂ instead of iodinated contrast reduces the risk of AKI and short-term renal function decline in this high-risk group.

This is a multicentre, open-label, prospective randomised controlled trial across six secondary-care National Health Service (NHS) vascular surgery centres. A total of 174 patients with PAD and CKD undergoing endovascular intervention will be randomised 1:1 to receive iodinated contrast (standard of care) or CO₂ via automated injector (Angiodroid). All perioperative care will follow local NHS protocols.

The primary outcome is log serum creatinine at 2, 30 and 90 days postprocedure. Key secondary outcomes include: incidence and severity of AKI within 48 hours postprocedure, major adverse kidney events (death, dialysis or >25% estimated glomerular filtration rate decline) by 90 days, inpatient length of stay, procedural pain, quality of life, procedural success, reinterventions, acceptability and feasibility (patient/practitioner questionnaires) of using CO₂, and cost-effectiveness (healthcare resource use analysis). A mixed-methods process evaluation will be undertaken with patients and clinicians.

The trial has been approved by an NHS ethical review committee (24/WA/0332) and patients have been involved in trial design. Findings will be disseminated to participants, clinicians and the wider public through patient groups, lay summaries, social media, conferences, peer-reviewed journals and NHS policy channels.

ISRCTN23564393.

The aim of this work was to understand carer involvement in transitions of care from hospital to home in relation to medicines management. Specifically, via a realist review, to describe how carers provide support, to what extent do they support patients and under what circumstances are carers able to provide support towards patient care in relation to medicines management.

A realist review was conducted in line with a published protocol and as registered via PROSPERO (CRD42021262827). An initial programme theory (PT) was developed before searches of three databases, PubMed, CINHAL and EMBASE, were conducted in accordance with eligibility criteria. Data were extracted from eligible studies and synthesised into realist causal explanations in the form of Context-Mechanism-Outcome-Configurations (CMOCs) and the PT was refined. Throughout the review, a patient and PPIE group (n≥5) was involved, meeting five times, to inform the research focus and develop CMOCs and the PT by providing feedback and ensuring they capture the carer experience.

Following title and abstract screening of 4835 papers, the final number of included articles was 208. The evidence synthesis identified 31 CMOCs which were categorised into three themes: (1) continuum of support; (2) understanding the carers’ priorities, role and responsibilities through shared decision-making (SDM) and (3) access to appropriate materials, resources and support information. These themes were formed into an updated PT with accompanying narrative that explained the transition from hospital to home involving carers in medicines management and identified possible areas for future intervention development.

This review provides insights and recommendations on how carers can be better supported when managing medicines when patients are discharged from hospital. Carers need a continuum of support throughout and following the transition. Healthcare professionals can support this by understanding the carer’s priorities, role and responsibilities through SDM during the hospital stay. Consequently, carers can then be offered access to appropriate materials, resources and support information which allows them to provide better care relating to medicines in the long term.

The McMaster Monitoring My Mobility (MacM3) study aims to understand trajectories of mobility decline in later life using multisensor wearable technology. To our knowledge, MacM3 is the first major cohort to combine accelerometry and a Global Positioning System (GPS) to track real-world mobility in community-dwelling older adults.

Between May 2022 and May 2024, MacM3 recruited 1555 community-dwelling older adults (mean age 73.9 years, SD=5.5) from Hamilton and Toronto, Ontario. Of the cohort, 68.4% were female, 62.4% married/partnered, 75.3% had post-secondary education and 62.9% had≥3 comorbidities. Most were Canadian born (69.4%) and white/Caucasian (88.0%), with greater ethnocultural diversity observed at the Toronto site.

At baseline, 56.7% of participants reported no mobility limitations, 15.9% had preclinical limitations and 27.4% had minor mobility limitations. Mean gait speed for the total sample was 1.23 m/s, with a mean Timed Up and Go time of 9.4 s and a 5x sit-to-stand time of 13.0 s. A total of 1301 participants had valid wrist-worn device data, and 1008 participants who agreed to wear the thigh-worn device had valid data (≥7 days with ≥10 hours of wear per day). Step count data (n=1008) revealed a mean of 8437 steps per day (SD=2943), with 5073 steps in the lowest quartile and 12 303 steps in the highest.

Ongoing work aims to develop predictive models of mobility decline by integrating wearable, clinical and environmental data. Pipeline enhancements will enable GPS/inertial measurement unit fusion to explore mobility-environment interactions and support ageing-in-place tools.

Severe aorto-iliac steno-occlusive atherosclerotic disease is a major cause of morbidity and amputation in patients with peripheral arterial disease. While both open surgical and endovascular revascularisation are standard treatments in this patient group, there is no high-quality randomised evidence to determine which approach offers superior clinical and cost-effectiveness, leading to uncertainty and poor outcomes after intervention.

The EVOCC trial is a national, multicentre, parallel-group, superiority randomised controlled trial comparing open surgery to endovascular revascularisation in patients with symptomatic severe aorto-iliac occlusive disease. A total of 628 participants across 30 NHS sites in the UK will be randomised 1:1 to receive either open surgery or endovascular (minimally invasive) intervention. The primary outcome is amputation-free survival, defined as time to first event (major lower limb amputation or death). Secondary outcomes include mortality, cardiovascular events, hospital readmissions, re-interventions and quality-of-life measures. An internal pilot phase (10 sites, 6-month duration) will assess recruitment feasibility. A QuinteT Recruitment Intervention is integrated into the trial to optimise recruitment.

The trial has received ethical approval from a UK Research Ethics Committee (REC reference: 23/SW/0065; trial registration reference: ISRCTN14591444). Informed consent will be obtained from all participants.

The EVOCC trial is the first RCT assessing the clinical and cost-effectiveness of open vs endovascular revascularisation for severe aorto-iliac disease worldwide. The results will provide robust evidence to inform clinical practice and healthcare policies globally. Results will be disseminated via patient groups, online lay summaries, a trial website, social media, presentations in conferences, a formal scientific publication in a medical journal and direct communications with policymakers across borders.

ISRCTN14591444.

Evidence suggests a 38% risk reduction in breast and bowel cancer-specific mortality with higher levels of exercise, however, most of this evidence is observational. More clinical trials are needed to build strong evidence for exercise’s impact on recurrence and survival. This study aims to assess the feasibility, acceptability and potential efficacy of a remote, tailored exercise programme on disease-free survival in patients recently completing curative treatment for early-stage, high-risk lung, breast or bowel cancer.

This UK-based, multicentre randomised controlled basket feasibility trial compares a personalised, remote-delivered exercise programme supported by exercise professionals against usual care. Potential participants are approached if they are: aged 18 or over, diagnosed with high-risk, early-stage breast, bowel or lung cancer, and within 24 weeks of completing primary curative treatments. Participants complete objective measures of physical function (submaximal cardiovascular fitness, endurance, muscle strength and balance), body composition (bioelectrical impedance) and self-reported outcomes (total physical activity, sleep quality, general quality of life (QoL), cancer-related QoL and exercise confidence/motivation). Clinical case note review provides disease-free survival outcomes at 6, 12 and 24 months. The 12-week programme is delivered remotely (via phone, email and/or video conference) with trainer contact tapering off over the subsequent 12 weeks (24 weeks total). Recruitment is ongoing with a 660-participant goal. Descriptive measures (quantitative and qualitative) will be reported for feasibility outcomes: recruitment, adherence, retention rates, data collection quality, adverse events, intervention acceptability and fidelity. A process evaluation is being conducted concurrently and is reported separately. Kaplan-Meier curves will be plotted and median disease-free survival calculated for each arm. To determine intervention impact, a log-rank test (unadjusted) will compare 2-year disease-free survival between groups within and among cancer types. Secondary outcomes (physical function status, general/cancer-specific QoL and determinants of meeting activity guidelines) will be reported at each time point.

Ethical approvals were obtained through Hull York Medical School (ID: 23/SS/0060) and UK NHS Health Research Authority (ID: 327663). Findings will be submitted for publication in high-impact journals, presentation at national and international conferences, press releases where appropriate, and dissemination activities to be decided on with the Patient Advisory Group.

ISRCTN97662203.

Participation in physical activity (PA) is a cornerstone of the secondary prevention of stroke. Given the heterogeneous nature of stroke, PA interventions that are adaptive to individual performance capability and associated co-morbidity levels are recommended. Mobile health (mHealth) has been identified as a potential approach to supporting PA post-stroke. To this end, we used a Sequential Multiple Assignment Randomised Trial design to develop an adaptive, mHealth intervention to improve PA post-stroke – The Adaptive Physical Activity programme in Stroke (TAPAS) (Clinicaltrials.Gov NCT05606770). As the first trial in stroke recovery literature to use this design, there is an opportunity to conduct a process evaluation for this type of adaptive intervention. The aim of this process evaluation is to examine the implementation process, mechanism of change and contextual influences of TAPAS among ambulatory people with stroke in the community.

Guided by the Medical Research Council Framework for process evaluations, qualitative and quantitative methods will be used to examine the (1) implementation process and the content of TAPAS (fidelity adaptation, dose and reach); (2) mechanisms of change (participants’ response to the intervention; mediators; unexpected pathways and consequences) and (3) influence of the context of the intervention. Quantitative data will be presented descriptively, for example, adherence to exercise sessions. Qualitative data will be collected among TAPAS participants and the interventionist using semi-structured one-to-one or focus group interviews. Transcribed interviews will be analysed using reflexive thematic analysis. Key themes and sub-themes will be developed.

Ethical approval has been granted by the Health Service Executive Mid-Western Ethics Committee (REC Ref: 026/2022) (25/03/2024). The findings will be submitted for publication and presented at relevant national and international academic conferences.