Cancer Trials Ireland

BackgroundDementia affects approximately 64,000 people in Ireland, with 20,000 residing in long‐term care (LTC) facilities. Sensory impairments, including hearing and vision issues, are highly prevalent among residents with dementia (RwD) in LTC, affecting 75–90% and 40% of this population, respectively. These impairments often go undetected and unmanaged, exacerbating cognitive decline, social isolation, agitation, and reduced quality of life. The SENSE‐Cog Residential Care (SENSE‐Cog RC) feasibility study aimed to address this gap by evaluating a multicomponent sensory support intervention (SSI‐RC) designed to improve sensory health for RwD in LTC settings. The SSI‐RC intervention comprised four levels: sensory assessments and aids (glasses, hearing aids, listening devices) for residents, staff training (including “Sensory Champions”), environmental modifications, and organisational‐level mapping of sensory care pathways.MethodThis study explored the experiences of LTC staff involved in the intervention arm of the SENSE‐Cog RC feasibility trial. Semi‐structured interviews were conducted with 13 staff members, including Sensory Champions and LTC facility managers/Directors of Nursing, across four intervention‐arm facilities. Data were analysed thematically to identify key facilitators and barriers to implementation.ResultFindings indicated that the intervention was largely integrated into existing routines without significant disruption. However, challenges emerged across the four intervention levels. At the resident level, some RwD struggled to adapt to sensory aids, while others perceived no need for them. At the staff level, time constraints made it difficult to maintain sensory devices, complete personal sensory plans, and follow up on adherence. Sensory Champions highlighted the need for strong managerial support and teamwork to ensure RwD benefited from their sensory aids. At the environmental level, maintaining optimal lighting and noise levels required ongoing effort, adding to staff responsibilities. At the organisational level, collaboration with external providers needed further streamlining to ensure consistent and effective sensory care pathways.ConclusionThese findings highlight the importance of a structured, holistic approach to sensory care that aligns with the needs of RwD, staff, and the LTC environment. Insights from this study will guide further refinement of the intervention, enhancing its feasibility and scalability to improve quality of life for RwD and support LTC staff.

Background Urinary tract infections (UTIs) are the most common serious bacterial infections in febrile infants. Current UK guidelines recommend parenteral antibiotics for infants under three months with suspected UTI, despite evidence supporting oral therapy in low-risk infants. Objectives To assess whether oral antibiotics are non-inferior to parenteral antibiotics for treating suspected UTIs based on treatment failure, need for additional therapy, and secondary outcomes. Design Multicentre, randomised controlled, open-label, non-inferiority trial with embedded internal pilot. Setting Twenty one paediatric emergency departments and assessment units across the UK. Participants Infants aged 29–90 days with suspected UTI, abnormal urinalysis, and low risk of invasive bacterial infection. Exclusion criteria included prematurity, prior hospitalisation, structural renal abnormalities, and clinical signs of sepsis or meningitis. Interventions Participants were randomised 1:1 to receive either oral antibiotics or standard care with intravenous (IV) antibiotics for 36–48 hours pending urine culture results. Main outcome measures The primary outcome was the requirement for additional parenteral antibiotics within seven days of randomisation. A range of secondary outcomes were also planned, including treatment failure, time to recovery, adverse events, antibiotic adherence, quality of life, family impact, and healthcare resource use. Feasibility outcomes collected during the internal pilot included recruitment rate, site activation, protocol adherence, and retention. Clinical outcomes were collected but not powered for formal comparison. Results 27 participants were recruited between 20 May 2024 and 13 March 2025 (which included the 6 month internal pilot), representing 27% of the pilot target. Protocol adherence was high, and no cases of meningitis occurred. Two cases of bacteraemia (one per randomised group) had uncomplicated clinical courses. Oral therapy was associated with shorter hospital stays and reduced parental time off work. Conclusions While trial procedures were successfully implemented, recruitment challenges suggest that a larger randomised trial of this treatment comparison is not feasible in this setting. Trial management Northern Ireland Clinical Trials Unit (NICTU) Trial registration ISRCTN Clinical Trials Registry, ISRCTN10907780, Trial Dates 20 May 2024 to 13 March 2025

BackgroundCancers of the oesophagus and stomach are a major cause of morbidity and mortality. Research is crucial to improving outcomes. However, to maximise value and impact, areas of focus should be prioritised in partnership with patients.ObjectiveWe undertook a comprehensive analysis of UK and Ireland patient and healthcare professional (HCP) priorities for research into oesophagogastric cancers across the domains of prevention, diagnosis and staging, treatment, palliative care and survivorship.DesignA scoping exercise sourced research questions from patients and HCPs. These were consolidated and then confirmed by systematic review to represent a true research uncertainty. Research questions were scored on potential impact by an interdisciplinary group of HCPs and prioritised using a weighting derived from a patient survey.ResultsThere were 835 (395 HCP, 440 patient) respondents to the scoping (n=455) and prioritisation (n=380) surveys. Across these, 4295 suggested research uncertainties were consolidated to 92 uncertainties that were prioritised. HCP respondents represented 25 professional groups from community and hospital settings. Patient weighting changed 22.2–46.3% of priority rankings established by HCPs. All domains were represented by the 20 highest priority questions, 5 of which focused on personalising and optimally combining treatment modalities. Two other key themes related to optimising nutrition and improving quality of life during and after treatment, including in patients not cured of their cancer.ConclusionThis work highlights the impact of patient input on HCP-ranked research priorities and provides a robust list of priorities to guide funders, policymakers and researchers to support and undertake impactful research.

5002 Background: Phase III post-hoc analyses show poor prognosis of PSA >0.2 in mHSPC treated by androgen deprivation therapy (ADT) and ARPI, but it remains unclear 1) when PSA cutoffs should be interpreted for prognostic significance, and 2) how PSA cutoffs may differ in real-world multinational data. IRONMAN (International Registry for Men with Advanced Prostate Cancer) prospectively enrolled mHSPC patients from 16 countries and is a unique large data set to investigate these questions. Methods: Patients with mHSPC who received ADT, ARPI +/- docetaxel with PSA data enrolled in the IRONMAN registry were included. 3 PSA strata (>0.2, 0.02 to 0.2, and <0.02ng/ml) were defined at 6- and 12-months (primary analysis) after treatment start. Multivariable Cox proportional hazard regression models were constructed for overall survival (OS) and progression-free survival (PFS, as defined by any of biochemical, radiographic or clinically progression) with adjustment for disease characteristics. A 12-month landmark population was constructed to determine conditional OS and PFS in each PSA stratum. Results: 1288 patients received ADT and ARPI within 90 days of IRONMAN enrolment and met inclusion. Key characteristics were median age 70 years, 69.5% de-novo metastatic, 59% Gleason 8-10, 73% Caucasian, 8.2% Black, 1.5% Asian, 7.3% lung metastases, 3.4% liver metastases, and 53.2% enrolment from centers outside US/Canada. Intensification agents were: abiraterone acetate (576, 44.7%), apalutamide (283, 22.0%), darolutamide (135, 10.5%), or enzalutamide (294, 22.8%), and 122 (8.7%) received docetaxel in addition to ADT-ARPI. PSA at 6, 12 month landmarks respectively were: <0.02 (10%, 21%); 0.02-0.2 (41%, 45%); >0.2 (49%, 34%), with 70% of patients with 6-month PSA >0.2 retained at 12-months. Outcome data in the 12-month landmark cohort are detailed in Table 1, with 3-year OS for the PSA >0.2 stratum significantly worse than the PSA<0.02 stratum (45.3 vs 92.7%, p<0.001), representing a 7-fold mortality risk in the Cox model adjusted hazard ratio (aHR) and 8-fold risk of progression. Conclusions: IRONMAN provides large real-world data validating the poor prognosis of mHSPC with PSA>0.2 after 6-12 months ADT-ARPI treatment and these patients could be targeted for intensification in future trials. Conversely, PSA<0.02 at 6-12 months defines the best prognosis and may be of interest for de-intensification strategies. OS and PFS outcomes by 12-month PSA strata. 12-mo PSA (ng/ml) n 3-yr OS [95%CI] 3-yr PFS [95% CI] OS Cox model mortality risk [95% CI] >0.2 264 45.3% [36.7-55.9] 36.7% [28.6-47.1] aHR 7.34 [3.66-14.71] 0.02-0.2 585 80.0% [74.5-85.9] 72.9% [66.9-79.1] aHR 2.16 [1.06-4.41] <0.02 439 92.7% [87.9-97.8] 93.0% [88.6-97.5] reference

Harmonized global collaborations are crucial to improving outcomes in hormone sensitive operable breast cancer.

IntroductionSleep disturbance is commonly experienced by cancer survivors, with rates ranging from 25-59%. Often this can be due to vasomotor symptoms (VMS), particularly in women who are ineligible for menopause hormonal therapy.MethodsThe MAC Study ((NCT04766229) was a prospective, single arm, phase 2 trial examining the impact of a composite intervention consisting of -Non-hormonal pharmacotherapy to manage VMS -Digital CBT for insomnia (dCBT-I) through Sleepio (BigHealth) -Self-management strategies for VMS, -Nominated support person. The trial met its primary endpoint, improvement cancer-specific global quality of life (QOL), here we present data on sleep outcomes as a secondary end point.Results204 women (82% history of breast cancer). were recruited, with a median age of 49, (range 28 – 66). 93% met diagnosis criteria for insomnia (SCI<16) at baseline, which reduced to 45.2% at 6 months (p<0.001). The mean SCI score increased from 8.5 (SEM 0.4) to 17.3 (SEM0.5) at 6 months (p<0.0005). Clinically relevant changes were seen in sleep parameters, with sleep onset latency reducing by 13.6 minutes after completion of dCBT-I (p<0.001). A 35 minute reduction in wakefulness after sleep onset was also seen (p<0.001) alongside a 29.1% improvement in sleep quality (p<0.001). Comparison of breast cancer and non-breast cancer patients demonstrated the intervention was equally effective in both groups.Conclusion/ImplicationsThe MAC study demonstrated that a targeted composite intervention can improve sleep and self-reported insomnia symptoms for women with troublesome VMS after a cancer diagnosis, which contributed to an improvement in cancer specific global QOL.