Single-arm Feasibility Study Research Articles

“Optimizing Wellness and Neurorehabilitation with Mindfulness (OWNMindfulness)”: feasibility of a novel mindfulness-based rehabilitation intervention for Persisting Symptoms after Concussion

Background Persisting Symptoms after Concussion (PSaC) are common and difficult to treat. Mindfulness-based interventions can support recovery but are rarely included in rehabilitative care. We developed OWNMindfulness, an eight-week live-video mindfulness-based group for PSaC. Purpose To assess feasibility and preliminary clinical effects of OWNMindfulness. Methods Fourteen individuals with PSaC enrolled in this mixed-methods single-arm feasibility study. We assessed enrollment/retention, adherence, fidelity, instrument completion, safety, and satisfaction. We evaluated preliminary trends in the impact of the intervention on mindfulness (CAMS-R), concussion symptoms (PCSS), and QOL (WHOQOL-BREF). Qualitative analysis of exit interviews explored participants’ perceptions of the effects of the intervention, and framework analysis assessed adequacy of the quantitative measures to capture perceived effects. Results Feasibility results met a priori benchmarks. Mindfulness, concussion symptoms, and QOL scores improved (CAMS-R: adjusted p = 0.01, large effect size; PCSS: adjusted p = 0.03, moderate effect size; WHOQOL-BREF: not significant, small effect size). Qualitative analysis of interview data found benefits including validation, compassion, self-awareness, self-efficacy, concussion symptoms, resilience, life participation, social relationships, and QOL. Framework analysis demonstrated that quantitative tools captured change in concussion symptoms but did not comprehensively assess the other benefits identified through qualitative methods. Conclusions OWNMindfulness shows preliminary feasibility and promise for improving clinical outcomes. Results suggest the need for additional quantitative tools for comprehensive measurement of the effects and may point to potential mechanisms of action.

Management of inoperable malignant bowel obstruction using the 4-step BOUNCED diet.

Malignant bowel obstruction (MBO) presents with multiple symptoms. The 4-step BOUNCED diet educates patients to self-manage oral intake according to symptoms. It includes clear fluids, thin liquids, purée and soft, sloppy foods, which are low in fibre. This mixed methods single-arm feasibility study aimed to establish if the diet could reduce MBO symptoms in patients with inoperable colorectal and gynaecological malignancies. The secondary objectives were to investigate if it was easily followed, improved quality of life (QOL) and reduced hospital admissions. Patients able to tolerate an oral diet with one or more symptoms (pain, bloating, early satiety, nausea and vomiting) were eligible. Following informed consent, an oncology dietitian took a diet history and determined which step of the diet they needed to follow using a detailed patient information leaflet. Patients remained on the trial for 28 days. Symptom and QOL data were collected on Days 1 and 28 using the Memorial Symptom Assessment Scale and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) questionnaires. Thirty patients (24 female, 6 male) aged 18-85 years consented from March 2021 to November 2022. Twenty-six participants completed the trial and 25 found the diet very easy or easy to understand. There was a significant reduction in pain from 96% on Day 1 to 63% on Day 28 (p = 0.004). The mean increase of EORTC global health status/QOL was 23.5 points, 95% CI (12.4-32.5) (p ≤ 0.001). There was a significant difference between number of admissions (p = 0.018) and bed days (p = 0.004) in the 28 days prior to consent compared to the trial period. A modified consistency low-fibre diet is easily followed, may reduce symptoms of MBO, admissions to hospital and improve QOL.

Cadence-Based Pedometer App With Financial Incentives to Enhance Moderate-to-Vigorous Physical Activity: Development and Single-Arm Feasibility Study.

High levels of physical activity are key to improving health outcomes, yet many people fail to take action. Using pedometers to target steps per day and providing financial incentives is a simple and scalable approach to promoting public health. However, conventional pedometers do not account for "intensity" and "duration," making it challenging to efficiently increase people's moderate-to-vigorous physical activity (MVPA), which is expected to improve health outcomes. Based on these rationales, we developed a smartphone app that sets step cadence as a goal (defined as a daily challenge of walking more than 1500 steps in 15 minutes twice a day, which is a heuristic threshold for moderate physical activity) and provides financial incentive when the challenge is met. This study aimed to evaluate the feasibility of our novel app and explore whether its use can increase users' daily MVPA. A single-arm pre-post study evaluated the feasibility and efficacy of the app. A total of 15 participants used app 1 (an app without financial incentives) for the first period (4 weeks) and then switched to app 2 (an app with financial incentives) for the second period (4 weeks). The primary outcome was the difference between the first and second periods in the number of successful challenge attempts per week. Secondary outcomes were differences between the first and second periods in daily steps and distance walked. Exploratory outcomes included the difference between the first and second periods in daily "heart points" as measured by Google Fit, a publicly available app that measures users' daily MVPA. The number of successful challenge attempts per week increased significantly compared to the first period (5.6 times per week vs 0.7 times per week; P<.001). Although not statistically significant, there was a trend toward an increase in the mean steps per day and distance walked per day (6586 steps per day vs 5950 steps per day; P=.19; and 4.69 km per day vs 3.85 km per day; P=.09, respectively). An exploratory end point examining daily MVPA by "heart points" collected from Google Fit also showed a significant increase compared to the first period (22.7 points per day vs 12.8 points per day; P=.02). Our app using step cadence as a goal and providing financial incentives seemed feasible and could be an effective app to increase users' daily MVPA. Based on the results of this study, we are motivated to conduct a confirmatory study with a broader and larger number of participants. UMIN 000050518; https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000057420.

The development and testing of a single-arm feasibility and acceptability study of a whole foods diet intervention for adults with prediabetes and their offspring

BackgroundDiet is considered a first-line treatment option for prediabetes, a condition that affects 96 million United States (U.S.) adults. Diet patterns that prioritize whole foods (e.g., Mediterranean) are currently recommended to treat prediabetes. However, no studies have tested whether a U.S.-style diet pattern that prioritizes whole foods can be used to treat prediabetes. The purpose of this study was to assess the feasibility and acceptability of a whole foods diet for adults with prediabetes and their offspring prior to conducting a larger clinical trial.MethodsA 2-week single-arm pre-post experimental controlled-feeding intervention of a 2020–2025 Dietary Guidelines for Americans adapted whole foods diet (e.g., primarily focused on foods that have undergone limited processing or refinement) was conducted in adults (25–59 years) with prediabetes and their biological offspring (6–17 years). Families received 2 weeks of menus and grocery delivery and weekly counseling by a registered dietitian. Families were invited to attend an optional focus group session. Feasibility was based on having a ≥ 50% family completion rate with ≥ 80% completion of study outcomes. Measures included adult–child anthropometrics (weight [kg], body mass index [BMI] including BMI% and Z-scores for offspring, waist circumference [cm]) and child diet quality estimated using the 2015 Healthy Eating Index (HEI) from a single random food record. Wilcoxon signed rank was used to compare differences between baseline and 2-week anthropometrics measures and offspring total HEI scores. Qualitative data were analyzed using thematic analysis to understand factors attributed to diet adherence and acceptability.ResultsEight families enrolled (n = 8 adults, n = 12 offspring), with 7 families completing the study (12% attrition) and completing 100% of study outcome measures. Adults experienced a median weight loss of − 1.0 kg from baseline to 2 weeks (79.5 kg to 78.5 kg). Offspring had a 24-point increase in total 2015 HEI scores (median difference 50 to 74). Focus group participants (n = 4 adults) reported being satisfied with the program and expressed a willingness to continue the diet despite identified barriers.ConclusionsA whole foods diet that provides dietary support was found to be feasible and acceptable for families at risk for T2D. Future studies are needed to test the effects of the diet on prediabetes outcomes, diet quality, and diet adherence in adults and families.Trial registrationNCT05483972 at ClinicalTrials.gov. Registered July 25, 2022. https://clinicaltrials.gov/study/NCT05483972?cond=prediabetes&term=whole%20foods%20&rank=1

Implementing vocational rehabilitation for people with multiple sclerosis in the UK National Health Service: a mixed-methods feasibility study

Purpose To implement a job retention vocational rehabilitation (VR) intervention (MSVR) for people with multiple sclerosis (MS) and their employers in the UK National Health Service (NHS). Methods Multicentre, single-arm feasibility study with post-intervention interviews. MSVR was delivered by an occupational therapist (OT). Feasibility was assessed by recruitment rates, compliance, and practicality of delivery. Acceptability was assessed with post-intervention interviews. A survey assessed change in eight vocational outcomes (e.g., vocational goals, work instability) immediately post-intervention and at 3-month follow-up. Results Recruitment and training an OT was challenging. Twenty participants with MS, three employers, and three healthcare professionals were recruited. All participants but one completed the intervention. Factors affecting intervention adherence included annual leave and family responsibilities. MSVR was associated with improved vocational goal attainment post-intervention (t(18) = 7.41, p = <0.001) and at follow-up (t(17) = 6.01, p = <0.001). There was no change to the remaining outcomes. Interviews identified six themes: intervention impact, accessibility of support, the OT’s role, readiness for support, workplace supportiveness, and barriers to NHS delivery. Conclusion Challenges with recruitment, identifying newly diagnosed MS participants, and understanding the OT’s training needs to deliver the intervention were identified. The intervention demonstrated acceptability, but participants wanted it to continue for longer to address further needs.

Implementing a group singing intervention for postpartum depression within the Italian health service.

In the United Kingdom a singing intervention for Postpartum Depression (PPD) titled "Music and Motherhood" was found to be effective. The World Health Organization Regional Office for Europe coordinated a study to assess the feasibility of implementing and adapting the intervention in other countries. In Italy, recent studies have highlighted the need to promote the availability of effective interventions for PPD in primary care. To describe the implementation of "Music and Motherhood" within the Italian primary care services dedicated to pregnancy and postnatal care in three different geographical locations, thus providing an example of strategies for implementing an arts and health intervention in primary care that can improve health and well-being. A 10-week group singing intervention for mothers with PPD was conducted as part of a single arm feasibility study. Data were collected through one-to-one interviews, focus groups and questionnaires from the professionals involved in the implementation and selected participating mothers. A conceptual framework including acceptability, appropriateness, feasibility, fidelity, implementation process, costs and sustainability was adopted for analysis. Number of sessions attended by mothers and implementation outcome measures for acceptability, appropriateness and feasibility, each consisting of four items rated on a 5-point Likert scale were also gathered. The intervention was found to be inclusive of women from different socio-cultural backgrounds and appropriate to the context. The group setting and the use of an arts-based intervention helped to de-medicalise the process of care maximising resources. Singing helped mothers to express their feelings and find strategies to improve interaction with their child. Attention to mothers' needs and the co-presence of the professional singing leader and a health professional were among the key factors. The median number of sessions attended was nine out of 10. In terms of acceptability, almost 90% of the professionals were in complete agreement that they liked and approved the intervention. Our study adds to the evidence that an arts and health intervention proven effective in one culture and linguistic context can be adapted to another. Collaboration among health professionals and artists in the implementation process and adequate funding are instrumental in moving from project to programme level.

The CO-produced Psychosocial INtervention delivered by GPs to young people after self-harm (COPING): protocol for a feasibility study.

Self-harm in young people is a growing concern and reducing rates a global priority. Rates of self-harm documented in general practice have been increasing for young people in the UK in the last two decades, especially in 13-16-year-olds. General practitioners (GPs) can intervene early after self-harm but there are no effective treatments presently available. We developed the GP-led COPING intervention, in partnership with young people with lived experience and GPs, to be delivered to young people 16-25 years across two consultations. This study aims to examine the feasibility and acceptability of conducting a fully powered effectiveness trial of the COPING intervention in NHS general practice. This will be a mixed-methods external non-randomised before-after single arm feasibility study in NHS general practices in the West Midlands, England. Patients aged 16-25 years who have self-harmed in the last 12 months will be eligible to receive COPING. Feasibility outcomes will be recruitment rates, intervention delivery, retention rates, and completion of follow-up outcome measures. All participants will receive COPING with a target sample of 31 with final follow-up data collection at six months from baseline. Clinical data such as self-harm repetition will be collected. A nested qualitative study and national survey of GPs will explore COPING acceptability, deliverability, implementation, and likelihood of contamination. Brief GP-led interventions for young people after self-harm are needed to address national guideline and policy recommendations. This study of the COPING intervention will assess whether a main trial is feasible. ISRCTN (ISRCTN16572400; 28.11.2023).

A feasibility study of magnetic resonance pelvimetry in women of short stature to identify the risk of cephalo-pelvic disproportion

ObjectiveTo conduct a feasibility study to assess if MR Pelvimetry can be undertaken in short stature primigravidae, with a view to a main study to answer the question ‘can MR pelvimetry be used to predict cephalo-pelvic disproportion (CPD) in women of short stature?’. Study DesignThis was a prospective single arm feasibility study. In the first phase, patient and public involvement was undertaken to assess acceptability of the study. In the second phase, primiparous women of ≤ 160 cm in height were selected from antenatal clinics. Obstetricians and midwives were asked to inform all eligible women about the study. Patients were approached in the third trimester and written information about the study provided. If the patient agreed to participate, they were invited for consent. MR scans were performed from 36 weeks gestation. Patients and their obstetricians were not informed of the results of the MR until after delivery (in view of NICE and WHO recommendations on pelvimetry). ResultsMR scans were performed on 21/35 (60%) participants who consented. The study was conducted without adverse events and was acceptable to all participants. Data were available from 19 patients; 7 (37%) of whom had caesarean section (CS) due to CPD, 7 (37%) had assisted vaginal birth (AVB), while 5 (26%) had spontaneous vaginal births (SVD). Two patients who had an elective CS were not included in the analysis. The pelvic measurements especially anatomical conjugate (inlet), transverse diameter (mid cavity) and anteroposterior diameter at the outlet were larger in the SVD group in comparison to in-labour CS /AVB. Interobserver MR scan measurements were comparable between radiologists: intraclass correlation coefficient (ICC) range 0.68 to 0.95. ConclusionThis feasibility study suggests that conducting a full study to answer the research question ‘can MR pelvimetry predict CPD in women of short stature?’would be feasible and acceptable to patients. The recruitment, MR scan protocol, reporting, reliability of measures were all assessed and found acceptable for a trial. A trend was observed for smaller pelvic measurements in women who needed intervention compared with those who had a natural birth/SVD. With evidence from a full trial, this could have major implications for the management of short stature women, in terms of clinical practice and safety. Key messagesA large trial would be feasible and acceptable to assess whether MR pelvimetry can predict CPD in women of short stature. Despite the small number of patients, a trend was observed for smaller pelvic measurements in women who needed intervention compared to those who had spontaneous vaginal birth. Evidence from a large trial could help inform clinical practice, and provide information and choice for women at risk of CPD.

An intensified trans-sectoral nutritional intervention in malnourished patients with chronic pancreatitis improves diseases prognosis and identifies potential biomarkers of nutritional status.

Malnutrition is a common complication in chronic pancreatitis and associated with reduced quality of life and life expectancy. Nutritional support is considered mandatory in malnourished patients with chronic pancreatitis but there is only scarce evidence on optimal treatment modalities and the efficacy of nutrition therapy. Here, we investigated the feasibility and efficacy of an intensified nutritional intervention in malnourished patients with chronic pancreatitis and aimed to identify suitable indicators for monitoring nutritional status. We performed a single-arm feasibility study, in which malnourished patients with chronic pancreatitis received an intensified trans-sectoral nutritional intervention for 6 months. Multimodal treatment comprised face-to-face dietary counseling, oral nutritional supplementation, and a complementary telephone-based nutrition and exercise coaching. Patients underwent follow-up examinations after 28, 90, and 180 days, when we assessed changes in anthropometric and body composition measures, muscle function, Chronic Pancreatitis Prognosis Score (COPPS), as well as blood parameters and intestinal microbiota composition. Eleven out of 73 patients initially screened for study participation were enrolled in the trial of which 9 subjects (age (mean ± SD): 56.2 (±14.8) years; male: 67%; alcoholic etiology: 44%) underwent the complete intervention. Patients gained a median of 5.3 kg (8.6%) body weight, including 1.6 kg skeletal muscle mass, and significantly increased gait speed (p < 0.001). Ameliorated nutritional status and muscle function were associated with increased blood levels of IGF-1 and cholinesterase as well as altered gut microbiota composition on the phyla and genera level. Moreover, significant improvements in COPPS indicated reduced disease severity after 90 and 180 days. Malnourished patients with chronic pancreatitis benefit from intensified nutritional therapy. Besides ameliorated nutritional status, a multimodal intervention can improve muscle function as well disease prognosis. Future studies are needed to prove superiority to standard-of-care and to validate potential biomarkers for prospective monitoring of nutritional status. https://clinicaltrials.gov/study/NCT04476056, NCT04476056.

Feasibility test of WORK-ON: a vocational rehabilitation intervention for people with chronic inflammatory arthritis

BackgroundPeople with chronic inflammatory arthritis (IA) often have a reduced work ability. Consequently, they are at high risk of losing their jobs and being permanently excluded from the labor market. Therefore, we developed a new context-specific vocational rehabilitation intervention for people with IA based on the Medical Research Council’s framework for complex interventions. This intervention is called “WORK-ON” and consists of: (1) Initial assessment and goal setting by an occupational therapist experienced in rheumatology rehabilitation; (2) coordinated support from the same occupational therapist, including assistance in navigating the primary and secondary healthcare and social care systems; (3) group sessions for peer support; and (4) individually tailored consultations with physiotherapists, nurses, and/or social workers. This study investigates the feasibility of WORK-ON.MethodsA 6-month single-arm feasibility study with a pre-test post-test design was conducted to evaluate recruitment, intervention fidelity and delivery, data collection, and possible outcome measures. Work ability was the primary outcome, and sick leave, quality of life, fatigue, pain, physical activity, sleep, and well-being were the secondary outcomes evaluated.ResultsIn total, 19 participants (17 women and 2 men) with a median age of 55 years (range, 34–64) participated and completed WORK-ON. Of these, 17 participants completed patient-reported outcomes at baseline and follow-up, and the results indicated a tendency to improvement in work ability, quality of life, level of physical activity, decrease in pain, and increase in days of sick leave during the 6-month intervention period. The rehabilitation clinicians spent an average of 15.3 h per participant, and the participants spent an average of 13.5 h in the intervention.ConclusionsWORK-ON is considered feasible and has the potential to increase work ability among people with IA who are concerned about their future ability to keep working. Though, an adjustment of the intervention is needed before testing in a randomized controlled trial.

Zanubrutinib for the Treatment of Primary Membranous Nephropathy (PMN): Results of a Single-Arm Feasibility Study

Zanubrutinib for the Treatment of Primary Membranous Nephropathy (PMN): Results of a Single-Arm Feasibility Study

A plant-based diet is feasible in patients with Crohn's disease

BackgroundIncorporating plant-based diets as a supplement to medical treatment may have a beneficial impact on patients with Crohn's disease, however, research with intervention studies is required. ObjectiveTo investigate the feasibility of a plant-based diet intervention. Secondly, the purpose was to investigate whether such diet may reduce disease activity and enhance quality of life. Materials and methodsThis study was designed as a single arm feasibility study. Outpatients with Crohn’s disease in biological therapy were guided over twelve weeks towards a dietary lifestyle change. Outcome measuresFeasibility concerning recruitment, retention rate and compliance. Secondary outcomes were measures of patient reported outcome questionnaires (PROMS). Paired t-tests were used to examine changes in CO2 emissions, anthropology, biomarkers, and patient-reported data. Δ-values were used to investigate difference between dietary intake and requirements. Linear regression analyses examined the association between biomarkers and PROMS. ResultsIn total, 15 participants completed the intervention with easy recruitment and a retention rate at 87.6%. A clinically positive tendency was seen towards improved symptom scores for disease (HBI; p=0.028 and IBDQ; p=0.006) but not for fatigue (IBD-F; p=0.097), although none of these were statistically significant. Adverse effects were decreased protein intake (p=0.69) and slightly reduced muscle mass. It remains unclear to what extent the intervention contributed to the improved self-reported effects although perception of disease activity was improved. ConclusionThis study demonstrates that it is possible to retain patients following a plant-based diet. However, the dietary change required ongoing dietetic support with a focus on anti-inflammatory agents and the still unattainable protein requirements.

Addition of testosterone to endocrine care for transgender women: a dose-finding and feasibility trial.

Transgender women who underwent gonadectomy have lower serum testosterone concentrations than cisgender women. There is uncertainty regarding the dosing and side effects of supplementation of testosterone in transgender women. This study aimed to assess the feasibility of dosing testosterone to the cisgender female physiological range in transgender women. In addition, we explored changes in cardiovascular parameters, virilizing side effects, and clinical symptoms. This is an open-label, single-arm feasibility study. Participants initially went through a dose-titration phase with 2-week intervals of 0.07-0.09-0.13 mL (277-318-403 μg bioavailable testosterone) testosterone 2% gel to establish a dose leading to serum testosterone concentrations between 1.5 and 2.5 nmol/L. This dose was then continued for 8 weeks. Participants applied daily transdermal testosterone 2% gel (Tostran®) at the prescribed dosage. Testosterone was measured every 2-4 weeks. Laboratory analyses, side effects, and clinical symptoms were evaluated. In total, 12 participants were included. Most participants required a dose of 0.07 mL (277 μg bioavailable testosterone) or 0.09 mL (318 μg bioavailable testosterone) to reach serum testosterone concentrations of 1.5-2.5 nmol/L. Continuing this dose, testosterone concentrations remained stable throughout the study. Changes in clinical outcomes were in the desired direction, and side effects were mild. The use of testosterone supplementation in transgender women seems feasible and safe in the short term. Although dosing requires personalized titration, stable testosterone levels can be established. A blinded, placebo-controlled, randomized clinical trial is needed to study the clinical benefit.

2250 A mixed-method feasibility study of an intervention to reduce sedentary behaviour in community-dwelling older adults aged ≥ 75 years

Abstract Introduction Older adults are the fastest growing and most sedentary group in society. With sedentary behaviour associated with negative health outcomes, reducing sedentary time may improve overall wellbeing. This single-arm mixed-method feasibility study explored the acceptability of an intervention to reduce sedentary behaviour in community-dwelling older adults aged ≥75 years. Methods Participants were recruited from the Community Ageing Research 75+ Study (CARE75+) cohort, with factors such as age, frailty status, living arrangements and levels of sedentariness being considered. The intervention consisted of an educational booklet including advice on how to reduce sedentary behaviour, a smartwatch with a sedentary reminder function, educational group sessions and follow up phone calls. The 9-week intervention was conducted from June–August 2023. Reach, uptake, adherence, and adverse events were recorded, and the acceptability of the intervention was explored through semi-structured exit interviews. Results Of the 39 eligible participants, 10 consented (5 M:5F) and had a mean age 84.3 years. The intervention had an uptake and reach of 25.6%, and retention of 100%. No falls, hospitalisations or deaths occurred, and three cases of mild irritation were reported which resolved during the study. 100% adherence was observed for the group sessions and follow-up phone calls, and 65% for self-monitoring. Qualitative data suggests that participants were receptive of the intervention according to the domains of the Theoretical Framework of Acceptability, and suggestions were provided on refining the intervention components. Conclusion Strategies to reduce sedentary behaviour were tested on a diverse sample of community-dwelling older adults in the oldest old age group, with varying levels of sedentary behaviour and frailty status. The presented strategies appear to be acceptable, appropriate, safe, and high levels of adherence were observed. Participant feedback will be used to refine the intervention.

Can we improve the management of inoperable malignant bowel obstruction? Results of a feasibility study of elemental diet as an alternative to parenteral nutrition in patients with advanced gynaecological cancer

PurposeNutrition support in inoperable bowel obstruction (IBO) remains challenging. Parenteral nutrition (PN) is recommended if the prognosis is > 2 months. An elemental diet (ED) is licensed for strictures in Crohn’s disease but has not been used in malignant bowel obstruction. The aim of this study was to evaluate the use of ED in patients with IBO and provide a proof of concept of ED as an acceptable feeding option.MethodsThis was a mixed-methods single-arm feasibility study. The primary endpoint was to provide a ‘proof of concept’ of ED as an acceptable feeding option for patients with IBO. Secondary endpoints included taste acceptability, incidences of vomiting and pain, the proportion of women who tolerated ED, the number of cartons drunk, quality of life (QOL) and the number of women treated with chemotherapy. Patients (> 18 years) with CT-confirmed IBO who could tolerate 500 ml of liquid in 24 h remained on the trial for 2 weeks.ResultsA total of 29 patients were recruited; of those, 19 contributed to the analysis for the primary endpoint; 13 (68.4%) participants tolerated the ED; 26 patients contributed to MSAS and EORTC QLQ questionnaires at baseline to allow for the assessment of symptoms. At the start of the study, 18 (69%) of patients experienced vomiting, reducing to 4 (25%) by the end of day 15 of the study; 24 (92%) of patients reported pain at consent, reducing to 12 (75%) by the end of day 15. QOL scores improved from 36.2 (95% CI 27.7–44.7) at baseline to 53.1 (95% CI 40.3–66) at the end of day 15; 16 (84%) participants commenced chemotherapy within the first week of starting ED. The number of cartons across all participants showed a median of 1.3 cartons per day (range 0.8 to 2.5).ConclusionED is well tolerated by patients with IBO caused by gynaecological malignancies and may have a positive effect on symptom burden and QOL.

Memantine to Reduce Cognitive Impairment After Radiation in Children: A Pilot Study Evaluating the Feasibility of Memantine in Reducing Cognitive Impairment in Pediatric Patients after Radiation Therapy for Central Nervous System Tumors

Memantine is standard in certain adults receiving brain radiation therapy (RT) to decrease cognitive impacts, but it is unknown whether pediatric patients can take, tolerate, and/or benefit from memantine. In this prospective single-arm feasibility study, we hypothesized that pediatric patients receiving central nervous system (CNS) RT would tolerate memantine with good adherence. Patients aged 4 to 18 years with a primary CNS malignancy (excluding World Health Organization grade 4 astrocytoma, glioblastoma) receiving intracranial RT were eligible. A 6-month memantine course was given during and after RT, with dose titration in 5 mg increments over 4 weeks targeting a weight-based maximum (0.4 mg/kg to the closest 5 mg), not to exceed 10 mg twice a day. The primary endpoint was to achieve 80% drug adherence rate in 80% of patients measured 1 month after RT. Secondary objectives included memantine feasibility at 3 and 6 months. Eighteen patients enrolled from 2020 to 2022 and were prescribed memantine with RT. The study closed early to avoid competing with the phase 3 randomized Children's Oncology Group study ACCL2031. No predefined stopping rules were met. One patient withdrew for cognition-altering substance use, leaving 17 patients available for analysis. One patient discontinued memantine after one dose due to nausea. For the remaining 16 patients, there was a median of 100% pill completion rate (range, 74%-100%; n = 9/17 with 100% adherence) at 1 month after RT, with 15/16 (94%) with adherence rates >80%. At the 3- and 6-month post-RT time points for secondary endpoints, the median adherence rates were 100% (range, 55%-100%) and 96% (range, 33%-100%), respectively. Grade 1 to 2 fatigue, headache, and nausea were the most common toxicity events, at least possibly related to the study drug (n = 27), without attributable grade 3+ events. Memantine is a feasible, safe, and well-tolerated addition to multimodality treatment for pediatric CNS malignancies. Results of ACCL2031 are awaited to define the value of memantine in this population.

PET-CT-guided, symptom-based, patient-initiated surveillance versus clinical follow-up in head neck cancer patients (PETNECK2): study protocol for a multicentre feasibility study and non-inferiority, randomised, phase III trial

BackgroundApproximately 40% of treated head and neck cancer (HNC) patients develop recurrence. The risk of recurrence declines with time from treatment. Current guidelines recommend clinical follow-up every two months for the first two years after treatment, with reducing intensity over the next three years. However, evidence for the effectiveness of these regimes in detecting recurrence is lacking, with calls for more flexible, patient-centred follow-up strategies.MethodsPETNECK2 is a UK-based multi-centre programme examining a new paradigm of follow-up, using positron emission tomography-computed tomography (PET-CT)-guided, symptom-based, patient-initiated surveillance. This paradigm is being tested in a unblinded, non-inferiority, phase III, randomised controlled trial (RCT). Patients with HNC, one year after completing curative intent treatment, with no clinical symptoms or signs of loco-regional or distant metastasis will be randomised using a 1:1 allocation ratio to either regular scheduled follow-up, or to PET-CT guided, patient-initiated follow-up. Patients at a low risk of recurrence (negative PET-CT) will receive a face-to-face education session along with an Information and Support (I&S) resource package to monitor symptoms and be in control of initiating an urgent appointment when required. The primary outcome of the RCT is overall survival. The RCT also has an in-built pilot, a nested QuinteT Recruitment Intervention (QRI), and a nested mixed-methods study on patient experience and fear of cancer recurrence (FCR). An initial, single-arm feasibility study has been completed which determined the acceptability of the patient-initiated surveillance intervention, the completion rates of baseline questionnaires, and optimised the I&S resource prior to implementation in the RCT.DiscussionWe hypothesise that combining an additional 12-month post-treatment PET-CT scan and I&S resource will both identify patients with asymptomatic recurrence and identify those at low risk of future recurrence who will be empowered to monitor their symptoms and seek early clinical follow-up when recurrence is suspected. This change to a patient-centred model of care may have effects on both quality of life and fear of cancer recurrence.Trial registrationISRCTN: 13,709,798; 15-Oct-2021.

Brief intervention protocol by telephone delivered by nurses to patients with harmful alcohol use in primary health care: A feasibility trial

AimThe aim of this study is to examine the feasibility of a brief intervention protocol by telephone performed by nurses in primary health care facilities. MethodsA nonrandomized single-arm feasibility study was performed. The proposed intervention of this study is the Brief Intervention carried out by the nurse delivered by telephone, synchronously with alcohol users. The brief intervention is a motivational approach based on the FRAMES model, with its components being: Feedback, Responsibility, Advice, Menu of options, Empathy and Self-efficacy. To assess the feasibility of the protocol, we evaluated the procedure for enrolling participants, the acceptability of the protocol to participants, the satisfaction of the participants, convenience and treatment continuity. The quantitative data analysis was carried out in the R software, using descriptive statistics, categorical variables were reported by frequencies and percentages. For continuous variables, medians, means, standard deviations and range values were computed. ResultsWe followed the participants (n = 165) from baseline (T0) until 3 months (T1) and 6 months (T2) after the brief intervention. The partial effect suggests a reduction in alcohol consumption, and statistically significant differences were observed from baseline before the BI, with a decrease of 0.66 points in AUDIT scores at T1. Among the patients who completed the 3-month follow-up, 48 % reported a positive experience of receiving the brief intervention by the nurses, and 44 % reported a decrease in alcohol consumption. ConclusionsBrief intervention delivered by telephone was considered feasible and acceptable by primary health care patients, and they perceived improvement in their alcohol consumption after receiving the BI performed by nurses.

A group intervention for pregnant multiparas with fear of childbirth: A protocol of a feasibility study of the MOTIVE trial

BackgroundAlthough research interest in fear of childbirth has increased, interventions targeting especially multiparas with fear of childbirth have been overlooked, although untreated fear can cause serious adverse effects on the mother and the whole family. Thus MOTIVE (Multiparas overcoming Childbirth Fear Through Intervention and Empowerment), an intervention for pregnant multiparas with fear of childbirth, was designed. MethodsThis is a protocol of a single-arm non-randomized feasibility study of the MOTIVE trial with a mixed-methods design. The primary aim of the intervention is to assist pregnant multiparas with fear of childbirth, with the desired outcome to alleviate fear. MOTIVE consists of four group sessions (2 h each); three during pregnancy and one after giving birth and in addition of a phone call after birth. The intervention is provided by a midwife and a psychiatric nurse at the maternity hospital. Quantitative data will be gathered via self-report questionnaires at three time points, at baseline, at 4 weeks post-baseline and post-intervention. Qualitative data will be gathered by diaries, open-ended questions from post-intervention questionnaires, and individual interviews. The target is to assemble four groups of four multiparas over a 12-month period. DiscussionThe findings will provide insights into the feasibility and acceptability of the intervention and will inform revisions to it. The results will guide the development of a definitive, larger-scale trial evaluation to further examine the efficacy of the refined intervention.

Metagenomic Next-Generation Sequencing-Based Fine-Needle Aspiration in Patients With Suspected Infected Pancreatic Necrosis.

Fine-needle aspiration (FNA) is no longer recommended for diagnosing infected pancreatic necrosis (IPN) due to a high false-negative rate. Metagenomic next-generation sequencing (mNGS) is a valuable tool for identifying potential pathogens. We hypothesized that adding mNGS to the standard FNA procedure may increase diagnostic accuracy. This is a prospective, single-arm feasibility study enrolling patients with acute necrotizing pancreatitis complicated by suspected IPN. Computed tomography-guided FNA was performed immediately after enrollment, and the drainage samples were subjected to culture and mNGS assays simultaneously. Confirmatory IPN within the following week of the index FNA procedure was the reference standard. The diagnostic performance of FNA-mNGS and the impact of mNGS results on treatment were evaluated. Historical controls were used for comparison of clinical outcomes. There was no significant difference between mNGS and culture in the positive rate (75% vs 70%, P = 0.723). The accuracy of FNA-mNGS was 80.0%, with a sensitivity of 82.35%, specificity of 66.67%, positive predictive value of 93.3%, and negative predictive value of 40.0%. The results of the mNGS led to treatment change in 16 of 20 patients (80%), including implementing percutaneous catheter drainage (n = 7), expanding antibiotic coverage (n = 2), percutaneous catheter drainage and expanding coverage (n = 4), narrowing antibiotic coverage (n = 1), and discontinuation of antibiotics (n = 2). The FNA-mNGS approach was not associated with improved clinical outcomes compared with the historical control group. The addition of mNGS to standard FNA has comparable diagnostic accuracy with culture-based FNA and may not be associated with improved clinical outcomes.