Trials Unit Research Articles

What is the carbon footprint of academic clinical trials? A study of hotspots in 10 trials

BackgroundClinical trials are fundamental to healthcare, however, they also contribute to anthropogenic climate change. Following previous work to develop and test a method and guidance to calculate the carbon footprint...

Faricimab versus bevacizumab for neovascular age-related macular degeneration: Cost analysis based on real-world data from the Swedish Macula Registry.

To analyse the impact on cost if faricimab is used as the first-line treatment for neovascular age-related macular degeneration (nAMD) compared to standard treatment with bevacizumab. Retrospective registry study including real-world data from the Swedish Macula Registry between 2017 and 2022. The observed number of injections and visits for bevacizumab during the first two years of treatment was used (n = 437 patients). Number of faricimab injections was obtained from published clinical trial data and unit costs mostly from publicly available Swedish sources. The provider cost included medication and visit cost and societal cost included additionally patient travel cost. Costs are presented in 2023 EUR. The incremental societal cost of faricimab was 277 EUR per patient compared to bevacizumab in the base case. Medication cost was higher (1516 EUR) while visit cost (-1183 EUR) and patient travel cost (-56 EUR) were lower due to longer injection intervals. Faricimab was of similar cost as bevacizumab for patients residing far from the clinic. The faricimab injection interval and the number of bevacizumab injections were major drivers of uncertainty in the results. Faricimab represents a cost-effective alternative to bevacizumab for patients with nAMD in Sweden. Its extended treatment interval is particularly beneficial for patients living far from clinics, and if the real-life faricimab injection interval extends beyond 12 weeks. Our findings emphasize faricimab's potential to free up healthcare staff to treat a larger patient population with existing clinic resources.

Effects of the Addition of Local Microorganism Bioactivators (MOLs) to Tomato Waste and EM4 on the Composite Quality of Market Waste with Coffee Waste Source

Market waste that belongs to organic garbage, can be recycled into compost. The natural compounding process takes quite a while, so it requires bioactivators to speed up the compostage process. In addition to the EM4 bioactivator, bioactivators can be made by ourselves with tomato waste that called local microorganisms (MOL) of tomato waste. The carbon content of coffee amps is high enough that it can be used as a compound mixture material as a source of carbon. The study aims to analyze the influence of the addition of local microorganisms (MOL) of tomato waste and EM4 on the composite quality of the market waste with coffee amps as carbon sources. The composing process was done using a composer for 14 days. The study used nine units of trials with two treatments and one control with three repetitions. The entire parameters on both composts produced with the treatment have been in accordance with SNI 19-7030-2004 standards. In compounds with local microorganisms (MOL) of tomato waste, the average carbon content was 19,23%, nitrogen 1,19%, phosphorus 0,51%, potassium 0,35%, and the C/N ratio 16.26 with temperature 30.67°C and pH 6.93. Compared to the compound with the bioactive EM4, the average content of the carbon element was 18,48%, the nitrogen content was 1,15%, the phosphates 0,50%, the potassiums 0,31%, and the C/N ratio 16.16 with temperature 31°C and pH 6.97. The results show that local microorganisms (MOL) of tomato waste have potential as a substitute for EM4 bioactivators.

An updated comparative analysis of needs and role of patient navigation among early phase cancer clinical trial participants and non-participants at a single cancer center.

237 Background: Early phase clinical trials (EPCTs) assess the safety and toxicity of novel anticancer agents and represent opportunities for patients (pts) to try novel therapies when standard therapies have become ineffective. However, EPCT participants represent a vulnerable population with high financial toxicity and symptom burdens. EPCTs may add to these burdens by requiring frequent, long visits and additional procedures. Pt navigators perform needs assessments and provide guidance to pts as they move through the health care system. Navigation, which has a high level of acceptance among pts with cancer, can improve time from diagnosis to treatment, decrease pt anxiety, and improve participation of minoritized individuals in clinical trials. We hypothesized that EPCT participants would have higher navigation needs than those of non-EPCT participants with cancer. Methods: Utilizing a needs assessment conducted in person or by telephone, pts with cancer treated at Mount Sinai are assessed for 26 individual and systemic social drivers of health (SDoH) barriers by pt navigators at their trial screening visit. EPCT participants were defined as pts participating in a study in the Early Phase Trials Unit. Descriptive characteristics were assessed for all participants regarding demographic characteristics and SDoH barriers. Welch's T-test was used to compare differences in navigation encounters and SDoH barriers between the EPCT and non-EPCT pt groups. Results: From February 2023 to April 2024, 40 EPCT pts and 1290 non-EPCT pts completed the assessment. Median age was 60.5 and 63.1 years, respectively. Racial and ethnic self-identification included 17.5% vs. 19% Black pts and 10% vs. 17% Hispanic pts. EPCT pts had a mean 5.2 navigation encounters per pt compared to 3.05 in non-EPCT pts (p=0.002). Pts in the EPCT group were found to have an average of 2.8 SDoH barriers identified, in contrast to 2.0 in the non-EPCT group (p=0.002). The most common barriers identified in EPCT pts were institutional, knowledge, psychosocial and financial; in non-EPCT pts, transportation, institutional, knowledge and treatment adherence were most common. Interventions related to institutional barriers most frequently involved coordinating with the primary team and among departments. Interventions related to knowledge included providing education and teach back. Conclusions: EPCT pts had more SDoH barriers identified, higher acuity of barriers, and required more navigation encounters than non-EPCT pts. Participants in EPCTs are a vulnerable pt population for whom navigation is particularly warranted. EPCT pts Non-EPCT pts p value Navigation encounters, mean (SD) 5.20 (6.16) 3.05 (4.34) 0.002 SDoH barriers identified, mean (SD) 2.82 (1.83) 2.00 (1.66) 0.002

Establishing Protocols for Glycaemic Index Clinical Trials in an Academic Setting in Sri Lanka

The University of Peradeniya in Sri Lanka has initiated a Healthy Human Clinical Trial Unit (CTU) dedicated to post-prandial glycaemic response (PPGR) analysis. The present study, involving 42 participants aged 22-25 years, assessed the glycaemic index (GI) of four rice varieties: Super Kernel, Rathu Suduru, Ceylon Purple, and Red Fragrant. The results identified GI values ranging from 40 to 61, categorizing these varieties into low and medium GI groups, with Super Kernel and Rathu Suduru representing the lowest (40 ± 5.5) and the highest (61 ± 5.5) GI values, respectively. Glycaemic load (GL) values ranged from 8 to 12, falling into low and medium categories. This pioneering initiative validates the effectiveness of CTU in precise GI and GL evaluation for food labelling, which are essential for informing consumers about how different types of food impact the sugar levels in the bloodstream. Also, it is a precedent for future clinical nutrition research, emphasizing the need for consistent and harmonized methodologies in academic and regulatory contexts to support broader public health goals by providing accurate nutritional information to consumers. The processes and standards are detailed in a comprehensive guidebook (ISBN 978-624-94637-0-7), supporting the continuation and expansion of further PPGR studies.

Clinical Trial IBD Unit: The Role of the Study Nurse in Conduction of Trials and Patients' Care.

Clinical Trial IBD Unit: The Role of the Study Nurse in Conduction of Trials and Patients' Care.

PRECIOUS study (PREterm Caesarean/vaginal birth and IVH/OUtcomeS): does mode of birth reduce the risk of death or brain injury in very preterm babies? A cohort and emulated target trial protocol

IntroductionVery preterm babies are at risk of poor neurodevelopmental outcomes and death. Intraventricular haemorrhage (IVH) after birth is the most prevalent cause of this. Birth by caesarean section may protect...

Evaluating the use of paracetamol to prevent fasting headache during the first week of Ramadan: A randomized, open-label, clinical trial.

Fasting headaches frequently occur during the first few days of Ramadan, and treatment is challenging because of fasting. This study aimed to evaluate the effect of extended-release paracetamol on preventing fasting headaches. A randomized, open-label clinical trial investigated the efficacy of extended-release paracetamol at a daily dose of 1330 mg in preventing fasting headache. Adults aged 18 years and older were recruited through the Clinical Trial Unit at the King Saud University Medical City. The eligible participants in the study fasted 13.5 h daily during the first week of Ramadan. Participants in the treatment and control arms were followed up to investigate the occurrence, severity, and timing of headache symptoms via self-reporting using a standardized headache diary scale with a daily online link or phone call. The primary outcome was the frequency of headache episodes while fasting during the first week of Ramadan. A total of 238 participants were enrolled and randomized. Of these, 173 followed the protocol (80 treated, 93 control) for at least the first day and were included in the analysis. Most participants were young and healthy, with a mean age of 32.2 ± 10.2 years. More men were included in the study (102/173; 59.0%), a small proportion of participants were smokers (31/173; 17.9%), and almost all participants reported being coffee drinkers (165/173; 95.4%); nonetheless, these characteristics were evenly distributed between the two groups in the study. The overall incidence of headache episodes was 33.0% (57/173) on day 1 and decreased to 11.3% (18/159) on day 7. On average over the 7 days, no significant effect was observed for the treatment on the incidence of headache, as the findings from the generalized estimating equation model indicated (β = -0.398, p = 0.084; odds ratio = 0.67, 95% confidence interval [CI] 0.42-1.06). Moreover, there was initially no significant difference in the incidence of headache episodes between the treatment and control groups. However, the treatment group had significantly fewer headache episodes during fasting than the control group on day 3 (4/72 [5.6%] vs. 15/91 [16.5%], p = 0.031; relative risk [RR] = 0.34, 95% CI 0.12-0.97) and day 6 (5/69 [7.2%] vs. 20/90 [22.2%], p = 0.010; RR = 0.33, 95% CI 0.13-0.82). No adverse effects were observed during the study period. No significant differences were observed in the occurrence of fasting headaches between the two groups on most days during the study period. Additional studies are required to address fasting headaches during the first week of Ramadan.

A Hybrid Type III Effectiveness-Implementation Trial to Optimize Medication Safety With Oral Antitumor Therapy in Real-World: The AMBORA Competence and Consultation Center.

Implementation science endeavors to facilitate the translation of evidence-based research into clinical routine. The clinical pharmacological/pharmaceutical care program evaluated in the randomized AMBORA trial on medication safety with oral antitumor therapeutics (OAT) optimizes care delivery and provides significant benefits for patients, treatment teams, and health care systems. Thus, we aimed to investigate the implementation of this care program within the AMBORA Competence and Consultation Center (AMBORA Center). The AMBORA Center within a University Comprehensive Cancer Center offered several services (eg, patient consultations) and was evaluated according to the RE-AIM framework. This multicenter hybrid type III trial focused on implementation outcomes (eg, patient recruitment, referring units, evaluation of services) while concurrently investigating effectiveness (eg, side effects, medication errors). Quantitative and qualitative assessments were combined. The AMBORA Center conducted over 800 consultations with 420 patients in seven institutions. The primary end point of counseling 70% of patients treated with OAT was not reached. Patients were referred by 15 treatment units compared with 11 units in the AMBORA trial. On the basis of heterogeneous referral rates and characteristics across the institutions, barriers and facilitators of the implementation process were derived. Several survey results (eg, stakeholder interviews, online/paper-based questionnaires) reflected a high appreciation of services by patients and health care professionals. The severity of 60.1% (178 of 296) of detected side effects improved, and 86.3% (297 of 344) of medication errors were resolved. Despite not reaching the primary implementation outcome, the AMBORA Center included more treatment units and demonstrated patient benefit of the AMBORA care program by meeting all effectiveness outcomes. We outlined quantitative and qualitative implementation characteristics to enhance outreach and foster further dissemination of centers to optimize medication safety with OAT.

1559P Equity of access and clinical impact of genomic testing in patients with cancer in a UK early phase clinical trials unit

1559P Equity of access and clinical impact of genomic testing in patients with cancer in a UK early phase clinical trials unit

Population pharmacokinetics of oral fosfomycin calcium in healthy women.

Fosfomycin is an antibiotic extensively used to treat uncomplicated urinary tract infections in women, and it is available in different salts and formulations. The European Medicines Agency (EMA) recommends further studies to characterize the pharmacokinetics of fosfomycin calcium for oral administration and to justify its dosage recommendation. A population pharmacokinetic model of fosfomycin calcium was developed after oral administration to healthy women. A clinical trial (a randomized, open-label, bioavailability study of single and multiple doses of 1000 mg capsules, single dose of 500 mg capsule and single dose of 250 mg/5 mL suspension of oral fosfomycin calcium under fasted conditions in healthy women volunteers, Code: PD7522.22, EudraCT: 2020-001664-28) was carried out at the Clinical Trial Unit, Araba University Hospital (Vitoria-Gasteiz, Spain). Twenty-four healthy women were included in the study, and plasma samples were collected at different times over a period of 24 h. The concentration-time data of fosfomycin in plasma were modelled by a population approach using a nonlinear mixed-effects modelling implemented by NONMEM 7.4 (ICON Clinical Research LLC, North Wales, PA, USA). The pharmacokinetics of fosfomycin was best described by a two-compartment model. Creatinine clearance and body weight were identified as covariates for fosfomycin clearance and volume of distribution, respectively. This study provides relevant information on the pharmacokinetic profile of fosfomycin in women after oral administration as calcium salt. This population model may be very useful for establishing dosage recommendations of fosfomycin calcium to treat urinary tract infections in women.

Impact of Social Stories on social and emotional health of autism spectrum primary school children: the ASSSIST2 RCT with economic evaluation.

Differences in the way autistic children experience the world can contribute to anxiety and stress. Carol Gray's Social Stories™ are a highly personalised intervention to support children by providing social information about specific situations in an individual story. This randomised controlled trial aimed to establish whether Social Stories are clinically effective and cost-effective in improving social responsiveness and social and emotional health in children on the autism spectrum in schools. A multisite pragmatic cluster randomised controlled trial comparing Social Stories with care as usual. Eighty-seven schools (clusters) across Yorkshire and the Humber. Two hundred and forty-nine children were randomised via a bespoke system hosted at York Trials Unit (129 Social Stories and 120 care as usual). Recruitment was completed in May 2021. Participants were children aged 4-11 years with a diagnosis of autism, alongside teachers, interventionists and caregivers. Recruitment was via schools, NHS trusts, support groups and local publicity. The intervention included training for educational professionals and caregivers covering psychoeducation and implementation of Social Stories. Stories were written around contextualised goals around the child's need for social information. Interventionists read the Social Story™ with the child at least six times over 4 weeks during school. The primary outcome was the Social Responsiveness Scale-2 completed by teachers at 6 months (the primary end point), which measures social awareness, cognition, communication and behaviour. Data were collected from caregivers and educational professionals at 6 weeks and 6 months through questionnaires. Blinding of participants was not possible. At 6 months, the estimated difference in expected teacher-reported Social Responsiveness Scale-2 T-score (the primary end point) was -1.61 (95% confidence interval -4.18 to 0.96, p = 0.220), slightly favouring the intervention group. The estimated differences for the parent-reported secondary outcomes at 6 months were small and generally favoured the control group except the measure of children's quality-adjusted life-year (+ 0.001, 95% confidence interval -0.032 to 0.035) and parental stress (-1.49, 95% confidence interval -5.43 to 2.46, p = 0.460), which favoured the intervention group. Children in the intervention group met their individual goals more frequently than children who received usual care alone (0.97 confidence interval 0.21 to 1.73, p = 0.012). The intervention is likely to save small costs (-£191 per child, 95% confidence interval -767.7 to 337.7) and maintain a similar quality of life compared to usual care. The probability of Social Stories being a preferred option is 75% if the society is willing to pay £20,000 per quality-adjusted life-year gained. Limitations include considerable disruptions during the coronavirus disease 2019 pandemic. Social Stories are used in schools and represent a low-cost intervention. There is no clinically evident impact on social responsiveness, anxiety and/or depression, parental stress or general health. Benefits were observed for specific behavioural goals as assessed by the teacher, and Social Stories may serve as a useful tool for facilitating dialogue between children and school staff to address specific behavioural challenges. Usage should be at the school's discretion. Given the uncertainty of the results in light of coronavirus disease 2019, further work to establish the impact of Social Stories is merited. This trial is registered as ISRCTN11634810. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/111/91) and is published in full in Health Technology Assessment; Vol. 28, No. 39. See the NIHR Funding and Awards website for further award information.

FOUND Trial: randomised controlled trial study protocol for case finding of obstructive sleep apnoea in primary care using a novel device

IntroductionObstructive sleep apnoea (OSA) is a common, but underdiagnosed, sleep disorder. If untreated, it leads to poor health outcomes, including Alzheimer’s disease, cancer, cardiovascular disease and all-cause mortality. Our aim...

Streamlining electronic reporting of serious adverse events (SAEs) using the REDCap data collection system: the eSAE Project

BackgroundIt is essential that electronic data collection (EDC) systems are both compliant with regulations and the principles of Good Clinical Practice (GCP) to allow for the timely and accurate reporting of data including safety data. For clinical trials of investigational medicinal products (CTIMPs), investigators must immediately report to the sponsor any serious adverse event (SAE) that occurs in a site for which they are responsible. It is therefore expected that sponsors provide systems for timely review and reporting should a SAE be classified as a suspected unexpected serious adverse reaction (SUSAR). Challenges arise when data related to adverse events (AEs) needs to be re-entered for SAEs; this can be prone to error and may delay reporting. Additionally, recognising what has changed from an initial SAE report when an investigator responds to queries raised can cause errors.MethodA multi-disciplinary working group came together from a UK academic clinical trials unit (CTU) to establish if an electronic system could be created in the unit’s open-source EDC system—REDCap, to manage SAEs in an efficient way.ResultsA module has been created in REDCap to facilitate electronic SAE reporting: enabling an AE form to automatically trigger an SAE form for any AE which is also a SAE, prepopulating relevant fields of the SAE form, reducing the risk of delay and error when entering data into the SAE form. The system has also been developed with an embedded code to allow for instant visual recognition of any data updated following reporting to allow the sponsor to immediately review and resolve SAEs in a timely manner, complying with UK regulatory reporting. This functionality ‘The eSAE Project’ is now an active project for all of our new trials where data collection is undertaken using the REDCap system.ConclusionThe eSAE Project coded into REDCap offers a unique way of populating SAE forms with information already entered in the initial AE forms as applicable, coupled with highlighting any updates during the lifetime of the SAE for sponsors to identify any new information that needs to be reassessed to process and report the SAE.

Trial participants’ self-reported understanding of randomisation phrases in participation information leaflets can be high, but acceptability of some descriptions is low, especially those linked to gambling and luck

BackgroundEvidence indicates that trial participants often struggle to understand participant information leaflets (PILs) for clinical trials, including the concept of randomisation. We analysed the language used to describe randomisation in PILs and determine the most understandable and acceptable description through public and participant feedback.MethodsWe collected 280 PILs/informed consent forms and one video animation from clinical research facilities/clinical trial units in Ireland and the UK. We extracted text on how randomisation was described, plus trial characteristics. We conducted content analysis to group the randomisation phrases inductively. We then excluded phrases that appeared more than once or were very similar to others. The final list of randomisation phrases was then presented to an online panel of participants and the public. Panel members were asked to rate each phrase on a 5-point Likert scale in terms of their understanding of the phrase, confidence in their understanding and acceptability of the phrase.ResultsTwo hundred and eighty PILs and the transcribed text from one video animation represented 229 ongoing or concluded trials. The pragmatic content analysis generated five inductive categories: (1) explanation of why randomisation is required in trials; (2) synonyms for randomisation; (3) comparative randomisation phrases; (4) elaborative phrases for randomisation (5) and phrases that describe the process of randomisation. We had 48 unique phrases, which were shared with 73 participants and members of the public. Phrases that were well understood were not necessarily acceptable. Participants understood, but disliked, comparative phrases that referenced gambling, e.g. toss of a coin, like a lottery, roll of a die. They also disliked phrases that attributed decision-making to computers or automated systems. Participants liked plain language descriptions of what randomisation is and those that did not use comparative phrases.ConclusionsPotential trial participants are clear on their likes and dislikes when it comes to describing randomisation in PILs. We make five recommendations for practice.

Retention strategies are routinely communicated to potential trial participants but often differ from what was planned in the trial protocol: an analysis of adult participant information leaflets and their corresponding protocols

BackgroundRetaining participants in randomised controlled trials (RCTs) is challenging and trial teams are often required to use strategies to ensure retention or improve it. Other than monetary incentives, there is no requirement to disclose the use of retention strategies to the participant. Additionally, not all retention strategies are developed at the planning stage, i.e. post-funding during protocol development, but some protocols include strategies for participant retention as retention is considered and planned for early in the trial planning stage. It is yet unknown if these plans are communicated in the corresponding participant information leaflets (PILs). The purpose of our study was to determine if PILs communicate plans to promote participant retention and, if so, are these outlined in the corresponding trial protocol.MethodsNinety-two adult PILs and their 90 corresponding protocols from Clinical Trial Units (CTUs) in the UK were analysed. Directed (deductive) content analysis was used to analyse the participant retention text from the PILs. Data were presented using a narrative summary and frequencies where appropriate.ResultsPlans to promote participant retention were communicated in 81.5% (n = 75/92) of PILs. Fifty-seven percent (n = 43/75) of PILs communicated plans to use “combined strategies” to promote participant retention. The most common individual retention strategy was telling the participants that data collection for the trial would be scheduled during routine care visits (16%; n = 12/75 PILs). The importance of retention and the impact that missing or deleted data (deleting data collected prior to withdrawal) has on the ability to answer the research question were explained in 6.5% (n = 6/92) and 5.4% (n = 5/92) of PILs respectively. Out of the 59 PILs and 58 matching protocols that both communicated plans to use strategies to promote participant retention, 18.6% (n = 11/59) communicated the same information, the remaining 81.4% (n = 48/59) of PILs either only partially communicated (45.8%; n = 27/59) the same information or did not communicate the same information (35.6%; n = 21/59) as the protocol with regard to the retention strategy(ies).ConclusionRetention strategies are frequently communicated to potential trial participants in PILs; however, the information provided often differs from the content in the corresponding protocol. Participant retention considerations are best done at the planning stage of the trial and we encourage trial teams to be consistent in the communication of these strategies in both the protocol and PIL.

QAPI 113 - A Comprehensive infection control response to a norovirus outbreak on an adult inpatient hematologic oncology and clinical trials unit

QAPI 113 - A Comprehensive infection control response to a norovirus outbreak on an adult inpatient hematologic oncology and clinical trials unit

Global perspective of barriers in research among oncologists from low-middle income countries.

e13781 Background: Cancer research in low-middle income countries (LMICs) face unique challenges, hindering advancements in patient care. Understanding the practices, barriers and strategic needs encountered by oncologists in LMICs is essential for enhancing research capacities and patient outcomes. This study aimed to assess the barriers and facilitators of research among oncologists in LMICs. Methods: This online cross-sectional survey engaged a diverse group of practicing oncologists from LMICs between December 8, 2023 and February 6, 2024. Respondents include both oncology trainees and consultants primarily from Asia (63%), Africa (18%) and Europe (10%). Using a validated questionnaire (test-retest reliability: 0.98), data analysis was performed using frequency and percentages to detail the survey responses, with 95% confidence intervals calculated to ensure the findings reliability. Results: A total of 276 participants from 29 countries, with a mean age of 38 years, responded to the survey. Fifty three percent (n=146) were male and 46% (n = 126) were female, four participants chose not to disclose. Majority of the respondents were trained in medical oncology and related specialties, 71% (n = 196). Forty one percent (n = 113) of them had less than 5 years’ experience as a cancer physician, while a significant proportion were mid-career oncologists with 5 to 15 years of experience. Regarding individual level barriers; 3% (n = 7) had 60 - 100% protected research time, 3% (n = 8) had local and international mentors, 36% (n = 100) had no biostatistical training, 50% (n = 138) had no clinical trial design training, 11% (n = 29) had utilized qualitative design, 60% (n = 165) had not participated in a population-based study, and 83% (n = 228) had not participated in translational research. In relation to system-level barriers; 30% (n = 84) had inadequate research infrastructure and 43% (n = 120) had no clinical trials unit. Respondents rated the degree of implementation of new research findings into local clinical practice as 3 on a five-point Likert scale. Conclusions: This study highlights the critical gaps in research capacity, resource availability, and infrastructure among oncologists from LMICs. Addressing these barriers through targeted interventions is imperative for advancing cancer research and improving patient outcomes in LMIC settings.

A comparative analysis of needs and role of patient navigation among early-phase cancer clinical trial participants and non-participants at a single cancer center.

e23127 Background: Early phase clinical trials (EPCTs) assess the safety and toxicity of novel anticancer agents and represent opportunities for patients (pts) to try novel therapies when standard therapies have become ineffective. However, EPCT participants represent a vulnerable population with high financial toxicity and symptoms related to their cancer and previous treatments. EPCTs often require frequent visits and additional procedures which may be burdensome. Pt navigators perform needs assessments and provide guidance to pts as they move through the health care system. Navigation, which has a high level of acceptance among pts with cancer, can improve time from diagnosis to treatment, decrease pt anxiety, and improve participation of minoritized individuals in clinical trials. We hypothesized that EPCT participants would have higher navigation needs than those of non-EPCT participants with cancer. Methods: Utilizing a needs assessment conducted in person or by telephone, pts with cancer treated at Mount Sinai are assessed for 26 individual and systemic social drivers of health (SDoH) barriers by pt navigators at their trial screening visit. EPCT participants were defined as pts participating in a study in the Early Phase Trials Unit. Descriptive characteristics were assessed for all participants regarding demographic characteristics and SDoH barriers. Welch's T-test was used to compare differences in navigation encounters, SDoH barriers and navigator interventions between the EPCT and non-EPCT pt groups. Results: From February to December 2023, 31 EPCT pts and 3126 non-EPCT pts completed the assessment. Median age was 55.9 and 56.1 years, respectively. Racial and ethnic self-identification included 13% vs. 23% Black pts and 19% vs. 20% Hispanic pts. EPCT pts had a mean 4.87 navigation encounters per pt compared to 1.94 in non-EPCT pts (p < 0.001). Pts in the EPCT group were found to have an average of 24.97 SDoH barriers identified, in contrast to 2.68 in the non-EPCT group (p < 0.001). The most common barriers identified in EPCT pts were institutional, knowledge, and psychosocial; in non-EPCT pts, institutional, treatment adherence, and transportation barriers were most common. Furthermore, based on the identified barriers, EPCT pts required an average of 17.23 interventions, compared to 1.80 among those not in the EPCT group (p < 0.001). Interventions most frequently involved coordination with the primary team and education for pts in both groups. Conclusions: EPCT pts had more navigation encounters, SDoH barriers identified, and resultant interventions than non-EPCT pts. Participants in EPCTs are a vulnerable pt population for whom navigation is particularly warranted. [Table: see text]

A single-centre study evaluating a geriatric screening tool in oncology phase I trial patients.

Though cancer is more prevalent in the older population, this patient group are underrepresented in phase I oncology trials. We evaluated the use of a geriatric screening tool (SAOP3) in patients of 70 years of age or older who attended a Phase I Clinical Trials Unit, with the aim of assessing the feasibility of the tool and identifying potential unmet needs in this patient group. Twenty-two patients over the age of 70 completed the SAOP3 questionnaire. Geriatric impairments and needs were analysed with descriptive statistics. Qualitative responses were grouped in themes using structured thematic analysis. All of patients triggered at least 1 geriatric domain, most commonly mobility. Six core themes were identified as being important to the patient including family, friends and positivity. On cognition assessment over 20% of patients triggered as requiring further cognitive assessment. The group had a relatively high screen fail risk. In conclusion, routine geriatric screening withSAOP3 was feasible and identified areas of patient need. Results highlight the prevalence of psychological distress and cognitive impairment. Geriatric screening offers an opportunity for prehabilitation prior to trial and support during trial participation to optimise safety and improve trial access.