Feasibility Of Recruitment Research Articles

Cardioprotection with transcoronary saline infusion during primary angioplasty for ST-elevation myocardial infarction: design and rationale of the STEMI-Cool pilot study

Abstract Background Prompt restoration of blood flow in ST-segment elevation myocardial infarction (STEMI) with primary percutaneous coronary intervention (pPCI) improves outcomes, but is associated with myocardial stunning, increased infarct size, and microvascular dysfunction. To date, there is no effective therapy to reduce this ischaemia-reperfusion injury (IRI). Mild systemic hypothermia has demonstrated potential but is difficult to achieve and poorly tolerated. Transcoronary hypothermia delivers rapid and effective myocardial cooling, is well tolerated, but not effective when commenced after flow restoration. Coronary haemodilution during reperfusion has shown cardioprotective effects in preclinical studies but has not been fully assessed. Purpose STEMI-Cool is a pragmatic, registry-based randomised clinical trial to assess recruitment rate, feasibility, and safety of a simple protocol which we have reported in a proof-of-concept study. The study has commenced recruitment and aims to overcome the limitations of previous negative studies by combining the beneficial effects of transcoronary cooling and dilution, initiating the infusion prior to wire insertion - therefore avoiding initial unprotected reperfusion (likely to be the critical time for IRI), and avoiding significant delays in reperfusion. Moreover, we will explore mechanistic endpoints and an original method to quantify the intracoronary dilution (with a thermodilution-derived "haemodilution constant ratio"). Lastly, we will investigate ways to "engineer out" the thermistor wire so that the method could be applied to routine pPCI with conventional equipment. Methods Pragmatic broad eligibility criteria allow potential recruitment of all STEMI cases clinically eligible for pPCI. Sixty patients will be randomised 1:1 to standard of care or protected reperfusion with continuous infusion of room temperature saline through the guiding catheter, to achieve intracoronary temperature reduction of 6-8°C. The infusion commences prior to crossing the occlusion with a thermistor wire, which is used as guidewire, and continues for 10 minutes after flow restoration (i.e., TIMI flow≥2). Invasive coronary physiology studies are undertaken after pPCI. Novel and established biomarkers of myocardial damage and inflammation (including dipeptidyl peptidase 3, tumor necrosis factor α, and interleukins 1β, 6, 10) are measured in the preprocedural arterial blood. Cardiac imaging and clinical outcomes are assessed at 48h and 6-12 months. Nesting STEMI-Cool in our local registry Heart-ACS facilitates blood sampling and follow-up. Conclusions STEMI-Cool will primarily investigate recruitment rate, feasibility and safety of an innovative, simple cooling and diluting strategy for cardioprotection during pPCI. Mechanistic outcomes will explore inflammatory, microvascular, structural and functional changes. Finally, we will aim to simplify further the protocol for future research and potential clinical use.STEMI-Cool method schematicSTEMI-Cool protocol timeline

Home-Based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors: Protocol of the HEAL Sepsis Randomized Clinical Trial.

While sepsis, an exaggerated response to infection, can affect people of all age groups, it is more prevalent in middle-aged and older adults. Older adults suffer worse short-term and long-term outcomes than younger patients. Older sepsis survivors are commonly discharged to long-term acute care facilities, where they often die within 1 year. Those who return home from the hospital lose the momentum of physical function improvement after early inpatient rehabilitation, and often face exacerbation of comorbidities and decline in physical function. Additionally, patients who are discharged home often live at distant locations and are not able to commute to rehabilitation centers due to their poor health status. Therefore, remotely delivered exercise interventions tailored to this population hold promise to improve physical function safely and effectively after sepsis. However, this type of intervention has yet to be tested in this population. This study aims to assess the safety, feasibility, and ease of recruitment and retention of participants for a remotely delivered physical activity intervention for improving physical function in middle-aged and older sepsis survivors. The proposed intervention will be delivered through a digital health platform that comprises a patient-facing mobile app and a 12-week physical activity program specifically designed for middle-aged and older sepsis survivors with poor health status who may face challenges participating in traditional out-patient or community-based exercise interventions. This study is ongoing and plans to enroll 40 sepsis survivors aged 55 years and older who will be randomized to either a remotely delivered exercise intervention group or a control group (electronic health diary). Both groups will use a tablet containing the Health in Motion app (Blue Marble Health). The intervention group will receive a clinician-designed personalized avatar-guided home exercise program and reminders while the control group will self-report daily activities using the in-app health diary feature. This study is the first to use a home-based, remotely monitored 12-week exercise program to improve physical function in sepsis survivors. This study will evaluate the safety, feasibility, and efficacy, providing the necessary knowledge to design and calculate power for future larger trials. This study will provide important information for planning a future randomized clinical trial to test the efficacy of a remotely delivered exercise intervention in this high-risk population. ClinicalTrials.gov NCT05568511; https://clinicaltrials.gov/study/NCT05568511. DERR1-10.2196/60270.

Feasibility, Fidelity and Acceptability of a Person-Centred Care Transition Support Intervention for Stroke Survivors: A Non-Randomised Controlled Study.

Care transitions from hospital to home are a critical period for patients and their families, especially after a stroke. The aim of this study was to assess the feasibility, fidelity and acceptability of a co-designed care transition support for stroke survivors. A non-randomised controlled feasibility study recruiting patients who had had stroke and who were to be discharged home and referred to a neurorehabilitation team in primary healthcare was conducted. Data on the feasibility of recruitment and fidelity of the intervention were collected continuously during the study with screening lists and checklists. Data on the perceived quality of care transition were collected at 1-week post-discharge with the Care Transition Measure. Data on participant characteristics, disease-related data and outcomes were collected at baseline (hospitalisation), 1 week and 3 months post-discharge. Data on the acceptability of the intervention from the perspective of healthcare professionals were collected at 3 months using the Normalisation Measure Development Questionnaire. Altogether, 49 stroke survivors were included in the study: 28 in the intervention group and 21 in the control group. The recruitment and data collection of patient characteristics, disease-related data, functioning and outcomes were feasible. The fidelity of the intervention differed in relation to the different components of the co-designed care transition support. The intervention was acceptable from the perspective of healthcare professionals. Concerns were raised about the fidelity of the intervention. A positive direction of effects of the intervention on the perceived quality of the care transition was found. The study design, data collection, procedures and intervention were deemed feasible and acceptable. Modifications are needed to improve intervention fidelity by supporting healthcare professionals to apply the intervention. The feasibility study showed a positive direction of effect on perceived quality with the care transition, but a large-scale trial is needed to determine its effectiveness. Stroke survivors, significant others and healthcare professionals were involved in a co-design process, including the joint development of the intervention's components, contextual factors to consider, participant needs and important outcomes to target. ClinicalTrials.gov ID: NCT0292587.

Transition from Acute to Chronic Low Back Pain in a Community-Based Cohort

The transition from acute to chronic low back pain (LBP) in community settings is not well understood. The purpose of this study was to assess the feasibility of recruitment and estimate the transition and continuation of chronic LBP. We also explored characteristics associated with this transition to chronic LBP. We enrolled n=131 participants, of which n=118 (90%) completed 3-month outcomes and n=111 (85%) completed 6-month outcomes. Acute LBP was defined by a duration of <4 weeks and a 30-day LBP-free period before the current acute episode. Chronic LBP was defined as pain most or every day over the past 3 months. The transition from acute to chronic LBP at 3 months was 32.2% (38/118), and at 6 months, 80.6% (25/31) of participants who transitioned at 3 months continued to have chronic LBP at 6 months. Participants with more frequent acute LBP and at an intensity of 30/100 were more likely to transition to chronic LBP (Risk Ratio (RR)=3.13, 95% Confidence Interval (CI) 1.84, 5.30) and continue to have chronic LBP at 6-months (RR=3.10, 95% CI 1.48, 6.08). Higher risk on the STarT Back Screening Tool was associated with the transition to chronic LBP at 3 months (RR=1.73, 95% CI 1.28, 2.35) and continuation of chronic LBP at 6 months (RR=1.26, 95% CI 1.10, 1.45). The recruitment of acute LBP was feasible in a community setting. Acute LBP is a common condition in the community and frequently transitions to chronic LBP, suggesting the potential for substantial burden in the community. PerspectiveThis article presents the feasibility of conducting a community-based study to describe the transition, continuation, and psychosocial predictors of acute to chronic low back pain. These findings could help identify community participants at high risk of incident and continued chronic low back pain. Data AvailabilityThe data that support the findings of this study are available from the corresponding author, [AG], upon reasonable request.

StrokeCog-R: Protocol for a Pilot Randomised Controlled Trial Of A Novel Cognitive Rehabilitation Intervention For Post-Stroke Cognitive Impairment

Abstract Background Post-stroke cognitive impairment (PSCI) affects 50% of patients six months post-stroke and is associated with increased disability, reduced quality of life, diminished independence, and a higher risk of long-term care and dementia. Addressing cognitive impairment is crucial to maximise patient recovery, facilitate the return to pre-stroke activities, and optimise secondary prevention efforts. However, cognitive rehabilitation is underrepresented in standard stroke rehabilitation protocols. This pilot randomised controlled trial (RCT) aims to evaluate a novel cognitive rehabilitation intervention, StrokeCog-R, designed to enhance cognitive function in stroke survivors with PSCI. The primary aims are to assess the feasibility of patient recruitment and retention and to determine the statistical power needed for a definitive trial. A secondary aim is to evaluate the efficacy and acceptability of the intervention for individuals with mild-to-moderate PSCI. Methods Sixty-four consecutive stroke patients with mild-to-moderate PSCI will be recruited and randomly assigned to either the intervention group (StrokeCog-R) or the control group (usual care). The intervention involves five weeks of group-based cognitive rehabilitation using “Rehearsal-Based” and “Compensatory-Based” strategies, supplemented with tailored home activities. Cognitive function, self-efficacy, and caregiver psychological wellbeing will be assessed pre- and post-intervention (or control) and at a four-month follow-up. Intervention acceptability will be documented through focus groups following each intervention. Recruitment is ongoing, and the first intervention group has concluded. Results Recruitment and retention rates, the feasibility of randomisation, patient acceptability, and resource utilisation will be evaluated. Additionally, the effectiveness of various communication techniques for retaining participants between the intervention period and the four-month follow-up will be assessed. These data will inform recruitment strategies and the determination of necessary effect sizes to power a definitive trial. Conclusion This study will provide critical insights for a definitive trial, potentially making a substantial contribution to the evidence base for cognitive rehabilitation in stroke patients.

Recruitment feasibility and dietary and behavioral patterns in toddlers with ASD: Preliminary results from the Autism Eats program

BackgroundProblematic mealtime behaviors and inadequate diet quality are pressing concerns for children with autism spectrum disorder (ASD). This study aimed to evaluate recruitment feasibility and baseline outcomes of the Autism Eats program for children under 3 years with ASD. MethodsRecruitment feasibility was assessed through reach and participation rates. The Healthy Eating Index (HEI-2015) scores were calculated from 3-day food records. Problematic mealtime behaviors were assessed with the Brief Autism Mealtime Behavior Inventory. Parental feeding practices were assessed using the Child Feeding Questionnaire. Anthropometric measurements of children and parents were taken. Weight-for-length percentiles were calculated based on the CDC growth charts. Descriptive statistics, one-sample t-tests, and Spearman's rho correlations were used for data analysis. ResultsOf the contacted dyads, 74 % agreed to participate. All 51 enrolled dyads completed baseline survey (100 %), and 98 % completed 3-day food records and anthropometric measurements. Significantly higher problematic mealtime behaviors were observed, compared to the reference (e.g., Total score 55.7 vs. 32.5; p < .001). Children with ASD exhibited lower HEI-2015 scores than national data (e.g., Total score 59 vs. 62). A large proportion of the children (29 %) had a weight-for-length ≥ 95th percentile. Several significant associations were found among mealtime behaviors, diet quality, parental feeding practices, and weight status. ConclusionRecruitment was highly feasible, and the findings suggest that early nutrition intervention may hold promise in addressing problematic mealtime behaviors and promoting healthier dietary habits in young children with ASD.Clinical Trial Registration: This trial has been registered at www.ClinicalTrials.gov (NCT05194345).

Selective early medical treatment of the patent ductus arteriosus in extremely low gestational age infants: a pilot randomised controlled trial protocol (SMART-PDA)

IntroductionPatent ductus arteriosus (PDA) is the most common cardiovascular problem that develops in extremely preterm infants and is associated with poor clinical outcomes. Uncertainty exists on whether early pharmacotherapeutic treatment...

Evaluation of the Teaching Recovery Techniques intervention among newcomer students in Swedish schools: a randomised controlled trial turned into a feasibility study

BackgroundDuring recent years, Europe has faced the arrival of migrants whereof a considerable group of youth present mental health problems, such as symptoms of post-traumatic stress disorder (PTSD). Schools offer a safe environment for mental health interventions to these groups, yet there is limited research on the impact of school-based interventions addressing mental health problems in newcomer youths, especially in the Swedish context. This cluster randomized controlled trial (RCT) aimed to explore the effectiveness of the Teaching Recovery Techniques (TRT) intervention among newcomer students with PTSD symptoms in Swedish secondary schools.MethodsNine schools were randomly assigned to TRT or a wait list control group prior to the baseline assessment. Follow-up data were collected immediately following the intervention and three months post-intervention. In total, 531 students were approached, of which 61 gave consent and were eligible to be included in the study: 55 in TRT and 6 in the control condition. Given the low number of participants in the control condition, we merely analyzed students who had received TRT.ResultsWe report on feasibility of recruitment, data collection, intervention delivery and intervention effectiveness. In terms of intervention effectiveness, within subjects ANOVAs revealed significant reductions in PTSD symptoms and general mental health problems from baseline to the three months-follow-up (p < 0.001).ConclusionsOur results indicate that TRT is a promising school-based intervention for newcomer students with PTSD symptoms. For a successful implementation of TRT in the school context, schools need to be engaged and the implementation should be managed by a local coordinator.Trial registrationISRCTN, ISRCTN48178969, Retrospectively registered 20/12/2019.

Determining the optimal frequency of SARS-CoV-2 regular asymptomatic testing: A randomized feasibility trial in a home care setting.

The SARS-CoV-2 pandemic presented a challenge for caregiving relatives in the home care setting. Caregivers can transmit SARS-CoV-2 to their relatives who are often at high risk for a severe course of COVID-19. Regular testing of asymptomatic caregivers for SARS-CoV-2 may reduce the risk of transmission. The optimal method and frequency of regular asymptomatic testing is unknown. We conducted a prospective, randomised trial to assess the feasibility, recruitment and acceptance of different testing frequencies. This serves to inform a future definitive randomised controlled trial. We carried out a parallel three-armed feasibility trial, enrolling adult participants who provided home-based care for a relative at least twice a week. Participants were randomly assigned using sealed envelopes to either conduct saliva-based antigen self-testing at a frequency of once a week (group I), twice a week (group II), or every two days (group III). The participants completed questionnaires on a weekly basis. Main outcome measures were feasibility of recruitment, adherence to self-tests and distress caused by self-testing. We further collected data on the use of mouth-nose mask. From 25 March to 7 May 2021 we assessed 27 participants and randomised 26 in the study: 8 participants in group I, 8 in group II and 10 in group III. All participants completed the study. In group I 48/48 (100.0%; 95% CI 92.6% to 100.0%), in group II 93/96 (96.9%; 95% CI 91.2% to 98.9%) and in group III 209/210 (99.5%; 95% CI 97.4% to 99.9%) self-tests were carried out at home. Participants did not perceive regular self-testing as burdensome in any of the study arms. We did not observe any infection with SARS-CoV-2. During the study, mask adherence decreased from 35% to 19% in all groups. Conducting such a study was feasible. The participants tolerated regular self-testing well, which was reflected in a high level of test adherence. However, regular self-testing may have led to decreased protective behaviour. To demonstrate that regular asymptomatic testing reduces infection transmission, a future definitive trial should be performed at a time of a high prevalence of SARS-CoV-2 and be implemented as a multicentre study. The trial is registered with the German Clinical Trials Register, DRKS00026234.

A Prospective Observational Cohort Study for Newly Diagnosed Osteosarcoma Patients in the UK: ICONIC Study Initial Results.

There has been little change to the standard treatment for osteosarcoma (OS) over the last 25 years and there is an unmet need to identify new biomarkers and novel therapeutic approaches if outcomes are to improve. Furthermore, there is limited evidence on the impact of OS treatment on patient-reported outcomes (PROs). ICONIC (Improving Outcomes through Collaboration in Osteosarcoma; NCT04132895) is a prospective observational cohort study recruiting newly diagnosed OS patients across the United Kingdom (UK) with matched longitudinal collection of clinical, biological, and PRO data. During Stage 1, which assessed the feasibility of recruitment and data collection, 102 patients were recruited at 22 sites with representation from patient groups frequently excluded in OS studies, including patients over 50 years and those with less common primary sites. The feasibility of collecting clinical and biological samples, in addition to PRO data, has been established and there is ongoing analysis of these data as part of Stage 2. ICONIC will provide a unique, prospective cohort of newly diagnosed OS patients representative of the UK patient population, with fully annotated clinical outcomes linked to molecularly characterised biospecimens, allowing for comprehensive analyses to better understand biology and develop new biomarkers and novel therapeutic approaches.

A Brief Mind-body Intervention Is Feasible and May Prevent Persistent Pain After Acute Orthopaedic Traumas: A Randomized Controlled Trial.

Approximately 20% to 50% of patients develop persistent pain after traumatic orthopaedic injuries. Psychosocial factors are an important predictor of persistent pain; however, there are no evidence-based, mind-body interventions to prevent persistent pain for this patient population. (1) Does the Toolkit for Optimal Recovery after Injury (TOR) achieve a priori feasibility benchmarks in a multisite randomized control trial (RCT)? (2) Does TOR demonstrate a preliminary effect in improving pain, as well as physical and emotional function? This pilot RCT of TOR versus a minimally enhanced usual care comparison group (MEUC) was conducted among 195 adults with an acute orthopaedic traumatic injury at risk for persistent pain at four geographically diverse Level 1 trauma centers between October 2021 to August 2023. Fifty percent (97 of 195) of participants were randomized to TOR (mean age 43 ± 17 years; 67% [65 of 97] women) and 50% (98) to MEUC (mean age 45 ± 16 years; 67% [66 of 98] women). In TOR, 24% (23 of 97) of patients were lost to follow-up, whereas in the MEUC, 17% (17 of 98) were lost. At 4 weeks, 78% (76 of 97) of patients in TOR and 95% (93 of 98) in the MEUC completed the assessments; by 12 weeks, 76% (74 of 97) of patients in TOR and 83% (81 of 98) in the MEUC completed the assessments (all participants were still included in the analysis consistent with an intention-to-treat approach). The TOR has four weekly video-administered sessions that teach pain coping skills. The MEUC is an educational pamphlet. Both were delivered in addition to usual care. Primary outcomes were feasibility of recruitment (the percentage of patients who met study criteria and enrolled) and data collection, appropriateness of treatment (the percent of participants in TOR who score above the midpoint on the Credibility and Expectancy Scale), acceptability (the percentage of patients in TOR who attend at least three of four sessions), and treatment satisfaction (the percent of participants in TOR who score above the midpoint on the Client Satisfaction Scale). Secondary outcomes included additional feasibility (including collecting data on narcotics and rescue medications and adverse events), fidelity (whether the intervention was delivered as planned) and acceptability metrics (patients and staff), pain (numeric rating scale), physical function (Short Musculoskeletal Function Assessment questionnaire [SMFA], PROMIS), emotional function (PTSD [PTSD Checklist], depression [Center for Epidemiologic Study of Depression]), and intervention targets (pain catastrophizing, pain anxiety, coping, and mindfulness). Assessments occurred at baseline, 4 and 12 weeks. Several outcomes exceeded a priori benchmarks: feasibility of recruitment (89% [210 of 235] of eligible participants consented), appropriateness (TOR: 73% [66 of 90] scored > midpoint on the Credibility and Expectancy Scale), data collection (79% [154 of 195] completed all surveys), satisfaction (TOR: 99% [75 of 76] > midpoint on the Client Satisfaction Scale), and acceptability (TOR: 73% [71 of 97] attended all four sessions). Participation in TOR, compared with the MEUC, was associated with improvement from baseline to postintervention and from baseline to follow-up in physical function (SMFA, baseline to post: -7 [95% CI -11 to -4]; p < 0.001; baseline to follow-up: -6 [95% CI -11 to -1]; p = 0.02), PROMIS (PROMIS-PF, baseline to follow-up: 2 [95% CI 0 to 4]; p = 0.045), pain at rest (baseline to post: -1.2 [95% CI -1.7 to -0.6]; p < 0.001; baseline to follow-up: -1 [95% CI -1.7 to -0.3]; p = 0.003), activity (baseline to post: -0.7 [95% CI -1.3 to -0.1]; p = 0.03; baseline to follow-up: -0.8 [95% CI -1.6 to -0.1]; p = 0.04), depressive symptoms (baseline to post: -6 [95% CI -9 to -3]; p < 0.001; baseline to follow-up: -5 [95% CI -9 to -2]; p < 0.002), and posttraumatic symptoms (baseline to post: -4 [95% CI -7 to 0]; p = 0.03; baseline to follow-up: -5 [95% CI -9 to -1]; p = 0.01). Improvements were generally clinically important and sustained or continued through the 3 months of follow-up (that is, above the minimum clinically important different [MCID] of 7 for the SMFA, the MCID of 3.6 for PROMIS, the MCID of 2 for pain at rest and pain during activity, the MCID of more than 10% change in depressive symptoms, and the MCID of 10 for posttraumatic symptoms). There were treatment-dependent improvements in pain catastrophizing, pain anxiety, coping, and mindfulness. TOR was feasible and potentially efficacious in preventing persistent pain among patients with an acute orthopaedic traumatic injury. Using TOR in clinical practice may prevent persistent pain after orthopaedic traumatic injury. Level I, therapeutic study.

Quality of Life in Patients and Their Spouses and Cohabitating Partners in the Year Following a Cancer Biopsy (the Couples Cope Study): Protocol for a Prospective Observational Study.

Receiving a diagnosis of cancer is a profound and often very stressful experience. Few studies have prospectively recruited patients prior to receiving a new diagnosis of cancer and included spouses or partners. The aim of the Couples Cope Study is to understand the impact of undergoing a diagnostic biopsy and receiving a new cancer diagnosis on quality of life (QoL) in both patients and their spouses or partners, as well as on the quality of their relationship. This protocol paper describes the study design and assesses the feasibility of recruitment and retention. Study staff reviewed the schedules of collaborating physicians using specific encounter codes to identify patients scheduled for breast or prostate biopsies. Potential participants were prescreened via the electronic health record and sent a recruitment letter at least 2 to 3 weeks prior to their biopsy procedure. Patients subsequently underwent a phone screening to determine eligibility. Patients who enrolled provided study staff with contact information for their spouses or partners. All consent forms were completed online. Surveys were completed online prior to receiving the biopsy results (baseline), and at 1, 3, 6, and 9 months after the biopsy. Study staff engaged in ongoing, personalized contact with participants and sent assessment completion reminders via phone and email. A total of 2294 patients undergoing a breast or prostate biopsy were identified and 69% (n=1582) were eligible for phone screening following electronic health record prescreening. Of the 431 patients who underwent phone screening, 75% (n=321) were eligible to participate. Of the eligible patients, 72% (n=231) enrolled and 82% (n=190) of enrolled patients had an accompanying partner or spouse who also enrolled. A total of 77% (34/44) of patients who received a cancer diagnosis and 72% (26/36) of their spouses or partners were retained through 9 months, while 80% (53/66) of patients who received a benign diagnosis and 68% (42/62) of their partners were retained. Prospective recruitment of patients undergoing diagnostic biopsy and their partners is feasible and requires both strategic collaboration with providers and concerted prescreening and recruitment efforts by study staff. Importantly, this study was able to conduct all study activities online without disrupting clinical workflow and without requiring patients and their spouses or partners to come into the laboratory. Consideration should be given to the ratio of biopsies to cancer diagnoses, which can vary significantly by cancer type. Prospective studies are needed and can inform our ability to provide effective support earlier to couples facing a possible cancer diagnosis. Future studies should examine other tumor types that have received less attention in QoL studies, include behavioral and neurobiological assessments beyond self-report measures, and follow couples beyond 9 months in order to examine long-term effects on QoL. DERR1-10.2196/52361.

Study protocol for ADAPT-TDM: A beta-lactam antibiotic Dose AdaPtation feasibility randomised controlled Trial using Therapeutic Drug Monitoring

IntroductionCritically ill patients are at risk of suboptimal beta-lactam antibiotic (beta-lactam) exposure due to the impact of altered physiology on pharmacokinetics. Suboptimal concentrations can lead to treatment failure or toxicity....

Perceptions of non-disclosure of results in clinical trial designs for multicancer detection tests.

10546 Background: Multi-cancer detection tests (MCDs) are blood-based tests designed to detect multiple cancers. The National Cancer Institute (NCI) is planning a pilot study to ascertain the feasibility of recruitment and the necessary infrastructure, clinical workflow, and diagnostic pathways for conducting a large clinical trial to assess whether cancer screening using MCDs reduces cancer mortality. In preparation for these activities, the NCI conducted a qualitative focus group study with primary care physicians (PCPs) and laypersons to explore the acceptability of alternative MCD trial designs, including the disclosure vs. non-disclosure of MCD test results to study participants. Methods: Focus groups were conducted with convenience samples of PCPs (6 groups, N=45) and laypersons (4 groups, N=88) by a consumer research firm. Interviews used both open-ended questions and specific prompts to explore participants’ perceptions of alternative clinical trial designs. Interviews were audio-recorded and transcribed, and qualitative thematic analysis of interview transcripts was conducted to identify emergent themes. Results: In general, PCPs and laypersons reported a willingness to refer or participate in an MCD trial regardless of design, with the understanding that clear and transparent information would be provided in the consent process. However, both groups expressed concern with a trial design in which patients in the control arm would not receive their MCD test results—a design that would allow a marked reduction in sample size and time necessary to assess a mortality endpoint. PCPs noted that although this design might be ethically acceptable due to current clinical equipoise about MCD testing, they expressed concern about mistrust among patients and medical-legal liability. Laypersons had difficulty understanding the rationale for non-disclosure of MCD test results during a trial, and concerns about the ethics of non-disclosure. Some participants felt more comfortable if return of value with other information was included as part of routine study procedures. Participants were more comfortable with an alternative design involving delayed testing of stored blood samples from the control group after trial completion. PCPs also expressed concern about increased workloads if their patients enrolled. Conclusions: PCPs and laypersons had generally positive reactions to a trial to investigate diagnostic performance, pathways, and outcomes of MCDs. Concerns about study designs involving non-disclosure of results might be managed through return of value strategies, careful education, and clear communication of the benefits and risks of MCDs.

Use of gene expression patterns to identify unique molecular subtypes in muscle invasive bladder cancer: GUSTO.

TPS4621 Background: Muscle invasive bladder cancer (MIBC) is an aggressive disease with poor survival rates that are not improving. Curative treatment includes systemic neoadjuvant chemotherapy prior to radical cystectomy and adjuvant immunotherapy. However, many patients do not respond to chemotherapy or immunotherapy. Histologically similar MIBCs can be classified using gene expression patterns into unique molecular subtypes. Retrospective studies have shown that molecular subtypes each have unique biology and consequently respond differently to treatment. The GUSTO trial tests the hypothesis that outcomes can be optimized through subtype-guided allocation. Methods: Eligible participants are those with confirmed non-metastatic MIBC, an ECOG performance status 0-1, being considered for cisplatin-based neoadjuvant chemotherapy and radical cystectomy. Formalin-fixed diagnostic (TURBT) tumor samples undergo gene expression microarray analysis and characterization using the GUSTO Classifier (consisting of the Veracyte Decipher assay and TCGA_2017 classification system) to determine the molecular subtype: basal, neuronal, luminal infiltrated, luminal or luminal papillary. A total of 320 eligible patients (T2-4a N0 M0 or T(any) N1 M0 MIBC) will be randomized 1:1 to either standard of care treatment (neoadjuvant cisplatin and gemcitabine) or subtype-guided treatment (basal and neuronal subtypes - neoadjuvant cisplatin, gemcitabine, durvalumab and tremelimumab and adjuvant durvalumab; luminal infiltrated - neoadjuvant durvalumab and tremelimumab and adjuvant durvalumab; luminal and luminal papillary - proceeding directly to radical cystectomy). Sites are notified when a patient has been assigned a molecular subtype. Patients and sites in the standard of care arm remain blind to the genomic subtype. The trial has three stages: Stage 1 (after 6 months of recruitment) will assess feasibility of recruitment and molecular subtyping in clinical timelines. Outcomes include recruitment rate, time to, and success of subtype allocation. Stage 2 (after 24 months of recruitment) will confirm recruitment feasibility and assess sample size assumptions. Outcomes are recruitment numbers, distributions of subtypes, and pathological complete response (pCR) in the standard of care arm. A re-estimation of the sample size for stage 3 will be considered. Stage 3 (after 12 months post-cystectomy for the last participant randomized) will assess treatment outcomes using this stratified approach. The primary outcome for Stage 3 is the rate of pCR in each molecular subtype within the experimental arm. Progression between trial stages will be dependent upon achieving pre-defined criteria. Recruitment began in September 2023. The study will open the first 20 sites ready to proceed and is accepting expressions of interest. Clinical trial information: 17378733.

A feasibility study to assess a co-designed behaviour change intervention to support people living with achalasia

Abstract Introduction Achalasia is a rare oesophageal condition that affects the motility of the oesophageal body and the relaxation of the lower oesophageal sphincter. Even the most effective treatments are unlikely to be curative. The main goal of medical treatments and interventions are mitigation of symptoms. The medical interventions are pharmacologic, endoscopic and surgical treatments to achieve symptom relief. As all medical treatments only help to alleviate symptoms, it is important for people living with achalasia to use non-pharmacological interventions to manage their condition. Aim This study aimed to evaluate the feasibility of recruitment and assess the acceptability of a co-designed behaviour change intervention, targeting eating in a social setting for people living with achalasia. Methods The mixed-method study used pre- and post-intervention questionnaires and semi-structured post-intervention interviews. Achalasia Action (a UK-based support group) emailed members the study information and participants contacted the researcher to take part. The intervention was a workbook designed collaboratively by the researchers and people living with achalasia, with strategies built on the COM-B model (Capability, Opportunity, Motivation).[1] Participants were given up to two months to complete the workbook. The interview was optional and it was an opportunity for participants to give further feedback on the intervention. Quantitative measures were subjected to descriptive analysis reporting recruitment and retention rates, and self-reported changes in eating behaviours. Qualitative data were analysed descriptively using the APEASE criteria (Affordability, Practicality, Effectiveness and cost-effectiveness, Acceptability, Side-effects/safety, and Equity).[2] Results The study aimed to recruit 20 participants, and this target was achieved, resulting in a 100% recruitment rate. However, the post-intervention questionnaires were completed by only 10 participants, indicating a 50% retention rate from baseline. Quantitative measures demonstrated an improvement in confidence and enjoyment levels while eating in a social setting post-intervention and a decrease in symptoms such as pain, regurgitation, stress and anxiety. Qualitative feedback (n=5) on the intervention described enhanced social support and improved symptom management of achalasia in a social setting. Furthermore, the intervention met the APEASE criteria, indicating its usability and acceptability. Conclusion The recruitment success of this study underscores the feasibility of involving people living with achalasia in intervention research. However, with a retention rate of only 50% at follow-up, it is evident that future studies should consider recruiting a larger baseline sample to ensure the target is achieved. The study acknowledges that the sample size was small and limits the generalisability of the findings. However, this is a characteristic typical of feasibility studies; therefore, the study is designed to assess the feasibility of recruitment and implementing a co-designed intervention rather than drawing conclusions on its efficacy. The positive outcomes of the co-designed intervention highlights the importance of user involvement in developing interventions. The intervention demonstrated the potential to support people living with achalasia in eating in a social setting. The co-designed intervention has significant practical implications by providing healthcare professionals and support groups with a feasible, effective method to enhance the social eating experience of people living with achalasia, potentially improving their overall quality of life.

A multisite feasibility randomized clinical trial of mindfulness-based resilience training for aggression, stress, and health in law enforcement officers

BackgroundLaw enforcement officers (LEOs) are exposed to significant stressors that can impact their mental health, increasing risk of posttraumatic stress disorder, burnout, at-risk alcohol use, depression, and suicidality. Compromised LEO health can subsequently lead to aggression and excessive use of force. Mindfulness training is a promising approach for high-stress populations and has been shown to be effective in increasing resilience and improving mental health issues common among LEOs.MethodsThis multi-site, randomized, single-blind clinical feasibility trial was intended to establish optimal protocols and procedures for a future full-scale, multi-site trial assessing effects of mindfulness-based resilience training (MBRT) versus an attention control (stress management education [SME]) and a no-intervention control, on physiological, attentional, and psychological indices of stress and mental health. The current study was designed to enhance efficiency of recruitment, engagement and retention; optimize assessment, intervention training and outcome measures; and ensure fidelity to intervention protocols. Responsiveness to change over time was examined to identify the most responsive potential proximate and longer-term assessments of targeted outcomes.ResultsWe observed high feasibility of recruitment and retention, acceptability of MBRT, fidelity to assessment and intervention protocols, and responsiveness to change for a variety of putative physiological and self-report mechanism and outcome measures.ConclusionsResults of this multi-site feasibility trial set the stage for a full-scale, multi-site trial testing the efficacy of MBRT on increasing LEO health and resilience, and on decreasing more distal outcomes of aggression and excessive use of force that would have significant downstream benefits for communities they serve.Trial registrationClinicalTrials.gov, NCT03784846. Registered on December 24th, 2018.

MIRRORS: a prospective cohort study assessing the feasibility of robotic interval debulking surgery for advanced-stage ovarian cancer

ObjectiveTo establish the feasibility and safety of robotic interval debulking surgery following the MIRRORS protocol (robot-assisted laparoscopic assessment prior to robotic or open surgery) in women with advanced-stage ovarian cancer....

161 Peer Caregiver Navigation for Hospice Caregivers of Cancer Patients: A Feasibility Study

OBJECTIVES/GOALS: To evaluate the feasibility, acceptability, and appropriateness of a 1:1 peer-delivered psychosocial support intervention to family caregivers of hospice patients with cancer, and determine a range of potential effects of the intervention on psychological distress symptoms and perceptions of the caregiving experience. METHODS/STUDY POPULATION: Quantitative and qualitative data were collected from hospice caregivers of cancer patients who participated in a non-controlled pilot feasibility trial of a 1:1, peer-delivered psychosocial intervention called Peer Caregiver Navigation (PCN). The purpose of this study was to evaluate the feasibility, acceptability, and appropriateness of delivering PCN to hospice family caregivers of cancer patients, and to determine a range of potential effects of PCN on caregivers’ anxiety symptoms, depressive symptoms, self-efficacy, and benefit finding. Qualitative data were analyzed using deductive thematic analysis. For our study outcomes, we used both parametric and nonparametric t-tests to examine mean differences between outcomes at baseline and midpoint, and baseline and endpoint. RESULTS/ANTICIPATED RESULTS: The findings demonstrate that Peer Caregiver Navigation (PCN) is acceptable, appropriate, and feasible to deliver to hospice family caregivers of cancer patients. Appropriateness of our selected target outcomes was determined by confirming expected measurement change in depressive symptoms (lower), anxiety symptoms (lower), benefit finding (higher), and self-efficacy (higher). Exit interviews revealed that participants responded favorably to our selected measures for these outcomes and to our data collection time intervals. Moreover, recruitment and consenting processes, survey completion rates, and attrition outcomes (i.e., study exit due to active withdrawal vs. patient death) were analyzed to inform recruitment and retention feasibility for future studies. DISCUSSION/SIGNIFICANCE: Peer Caregiver Navigation (PCN) was determined to be feasible, acceptable, and appropriate to hospice family caregivers of patients with cancer. Moreover, PCN has the potential to improve caregivers' symptoms of psychological distress by providing them much needed psychoeducation, coping skills training, and emotional support.

Web-based cognitive rehabilitation intervention for cancer-related cognitive impairment following chemotherapy for aggressive lymphoma: protocol for a randomised pilot trial

IntroductionCancer-related cognitive impairment is common among people diagnosed with and treated for cancer. This can be a distressing and disabling side effect for impacted individuals. Interventions to mitigate cognitive dysfunction...