Feasibility Study Research Articles

My virtual escape from patient life: a feasibility study on the experiences and benefits of individualized virtual reality for inpatients in palliative cancer care

BackgroundCancer patients benefit from Virtual Reality (VR) in burdensome situations, but evidence is scarce for palliative situations. Based on earlier work in palliative care, individualized VR interventions like seeing the patient’s home may address a patient’s wish to be at home and thus have a greater effect compared to standard VR content. Yet, some patients and relatives may be concerned about their privacy. Also, patient stakeholders raised concerns about triggering depressed mood or homesickness.AimTo test the feasibility and safety of individualized vs. standard 360°video VR interventions in palliative cancer inpatients.MethodsProspective observational study with patient-reported outcome measurement using validated instruments of well-being (MDBF), symptoms and psychosocial burden (IPOS), cybersickness (SSQ), presence experience (SPES), subjective benefit (2 items), content analysis of interviews, and field notes. Individualized VR content was recorded with action camcorder-technology to protect the patients’ privacy.ResultsSeventeen patients participated, median age 65 years (range 20–82), 9 women (53%), 8 single or widowed (47%), 4 childless (23.5%), 4 academics (23.5%), with a median length of stay of 9 days (1–75) in the hematology (10), palliative care (3), or radiotherapy (2) unit of a German university hospital. Eight patients (53.3%) chose their own home environments or family for individualized VR-content. All participants enjoyed the intervention. Compared to standard VR content the individualized VR tended to have a stronger effect on well-being and emotional touch. It was not inferior in terms of psychosocial burden and cybersickness. No subjective and relevant side effects occurred. The patients well tolerated the assessments. However, most patients demanded a lighter headset and a desire for more interactivity.ConclusionsIndividualization of VR content shows potential for enhancement of immersion, which improves the VR experience and does not harm in terms of depressed mood or worsening of symptoms. The patients’ and family desire for privacy is feasible with the support of family members who recorded the individualized videos, which is easily manageable today. We suggest a pragmatic randomized clinical trial to compare the effects of individualized vs. standard VR-content.Trial registrationRegistered at German Clinical Trials Register (Deutsches Register Klinischer Studien; DRKS); registration number: DRKS00032172; registration date: 11/07/2023.

Combining music and dance movement therapy for people with dementia living in the community: A mixed methods feasibility study

Dementia is affecting an increasing number of people world-wide and presents a need to find more evidence-based therapies that can improve quality of life and care. Music therapy and dance movement therapy are two forms of arts therapies that share an active, embodied and improvisatory approach, however, maximising the benefits of combining music and dance movement therapy has not been researched with this population. In this feasibility study a convergent mixed methods design was used to evaluate the feasibility of using an intervention that combined music and dance movement therapy drawing on a systematic literature review. A dance movement therapist and a music therapist ran two session blocks involving eight participants in total. The Cornell Scale for Depression in Dementia was used at three assessment points (baseline, 5 weeks and 10 weeks) indicating an overall reduction in scores. Qualitative methods included multiple forms of data (video, reflective tool, journal) and focused on significant moments of connection between thoughts, feelings and physical sensations. It generated three main themes in the therapeutic process: making connections, acknowledging grief and loss, and growth and empowerment. This study contributes original knowledge to arts therapies research in the development of a research-based treatment approach involving a collaborative model of practice, an exploration of new arts-based data collection tools and testing this intervention in a community setting.

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

Normothermic Ex Vivo Perfusion Before Transplantation of the Kidney (NEXT-Kidney): A Single-center, Nonrandomized Feasibility Study.

There is conflicting evidence regarding the efficacy of normothermic machine perfusion (NMP) in suboptimal deceased donor kidneys. We aimed to assess the feasibility and short-term efficacy of brief preimplantation NMP in circulatory death (DCD) kidneys. In this nonrandomized, single-center, prospective clinical trial, DCD kidneys underwent 1 to 3 h of NMP before implantation, aiming to achieve short ischemic times off NMP. The primary outcomes included feasibility and safety. Secondary outcomes included efficacy outcomes (delayed graft function and estimated glomerular filtration rate (eGFR) at 1, 6, and 12 mo), which were compared with the contralateral kidney that did not receive NMP. Eighteen DCD kidneys underwent NMP between 2020 and 2022, with at least 1 h completed in 16 (88.9%) of these kidneys (median 1 h); one kidney was removed after 5 min because of cannula failure and another at 54 min because of a sudden drop in blood flows. There was no episode of graft loss on the machine or postoperative vascular thromboses. All 18 kidneys were transplanted, with no cases of PNF or graft loss at 12 mo. Seventeen of the contralateral CS kidneys were transplanted. Compared with the contralateral kidneys, a lower incidence of delayed graft function (23.5% versus 64.7%; P = 0.046) was observed. There were no differences in the eGFR slopes between the two groups over time (P = 0.254). NMP is safe, feasible and efficacious in the Australian setting, with this relatively small cohort demonstrating good early outcomes compared to CS alone in our study of DCD kidneys.

Hinotori™ robotic esophagectomy: a feasibility cadaver study.

This preclinical feasibility study investigates the potential of utilizing the hinotori™ robot system for esophagectomy. In three human cadaver models, the esophagus was successfully mobilized and resected using the hinotori™ system, with a mean thoracic procedure time of 57minutes. The system allowed for precise dissection and radical lymphadenectomy without arm collision, attributed to its versatile design and docking-free trocars. Standard robot-specific patient positioning, including a 35° left lateral inclination, and trocar placement in a posterior axillary line configuration were employed. Notably, trocars suitable for both laparoscopy and the hinotori™ robot were utilized, providing flexibility in trocar selection. Unique features, such as the ergonomic console and pointer-based pivot point identification system, contributed to procedural success. While these findings highlight the promising potential of the hinotori™ system in advancing esophageal surgery, further clinical studies are warranted to validate its reproducibility and clinical utility. Additionally, enhancements to the pivot point identification system and evaluation of the arm base's features may further optimize surgical outcomes.

Pregabalin for Neuropathic Pain and Itch in Recessive Dystrophic Epidermolysis Bullosa

Patients with recessive dystrophic epidermolysis bullosa (RDEB) experience neuropathic pain and itch. There is a lack of evidence on any treatment for these symptoms in patients with RDEB. To test the efficacy of pregabalin in the treatment of neuropathic pain and itch in patients with RDEB. A randomized, double-blinded, crossover trial of oral pregabalin (50-300 mg/d) vs placebo was conducted at 2 sites, Toronto (Canada) and Santiago (Chile) from January 1, 2019, to December 31, 2020. Patients eligible to participate were diagnosed with RDEB, aged 8 to 40 years, not pregnant or lactating (if female), and had evidence of probable neuropathic pain and itching defined as distal thermal sensory loss (confirmed by thermal roller), score of 4 or greater on the Douleur Neuropathique 4 questionnaire (DN4), and score greater than 4 on the 10-point visual analog scale [VAS]). Patients with a clinically important or poorly controlled medical or psychiatric condition or pregabalin intolerance or allergy were excluded. Of 41 patients screened, 3 were not eligible and 28 declined enrollment. Data analyses were performed in 2021 through 2023. Participants received both pregabalin and matched placebo (titrated to a maximum-tolerated dose of 300 mg/day) in a randomized sequence so that comparisons could be made within participants and between groups. Difference in the mean pain and itch scores between pregabalin and placebo treatment (measured using VAS) before and after intervention. In all, 10 participants were randomized to 2 groups, 6 patients (mean [SD] age, 26.7 [8.1] years; 3 females [50%]) in group 1, and 4 patients (mean [SD] age, 26.5 [7.8] years, 2 females [50%]) in group 2. Group 1 received a sequence of pregabalin-placebo while group 2 received placebo-pregabalin. Pregabalin significantly reduced mean (SD) pain scores by 1.9 (1.5) points when controlling for sequence and treatment period vs baseline, while placebo had 0.1 (2.0) points of reduction. The effect of pregabalin was a mild but significant reduction in itch compared to baseline (mean [SD] points, 0.9 [2.2]), whereas the placebo produced no reduction (0.1 [2.5]). The mean pregabalin dose was generally well tolerated. The results of this randomized crossover trial indicate that pregabalin significantly reduced pain and itch scores from baseline compared to placebo in patients with RDEB. This feasibility study provided preliminary data on the efficacy of pregabalin in managing pain and itch in RDEB and gathered essential data to inform the design of a larger cohort trial. ClinicalTrials.gov Identifier: NCT03928093.

Use of the Medtronic Hugo Robot-Assisted Surgery (RAS) System in Urogynecology: A Safety and Feasibility Study of the First 100 Procedures

Use of the Medtronic Hugo Robot-Assisted Surgery (RAS) System in Urogynecology: A Safety and Feasibility Study of the First 100 Procedures

A Person-Based Web-Based Sleep Intervention Aimed at Adolescents (SleepWise): Randomized Controlled Feasibility Study.

Adolescents are advised to sleep 8-10 hours per night; however, most do not sleep for this recommended amount. Poor adolescent sleep is associated with detrimental health outcomes, including reduced physical activity, risk-taking behaviors, and increased depression and anxiety levels, making this an important public health concern. Existing interventions targeting adolescent sleep are often unsuccessful or their effectiveness unclear, as they are frequently noninteractive, time-consuming, and lack a strong theoretical foundation; highlighting an urgent need for innovative interventions deemed acceptable by adolescents. The main objective of this study was to determine the acceptability, feasibility, and preliminary impact of a web-based person-based sleep intervention (SleepWise) on adolescent sleep quality. Participant incentivization was also explored to understand its impact on engagement, acceptability, and sleep quality. A feasibility trial was conducted to test the feasibility, acceptability, and preliminary impact of SleepWise on adolescent sleep quality, developed based on the person-based approach to intervention development. In total, 90 participants (aged 13-17 years) from further education institutions and secondary schools were recruited for two 2-arm randomized controlled trials. One trial (trial 1) was incentivized to understand the impact of incentivization. Acceptability and sleep quality were assessed via questionnaires, and a mixed methods process evaluation was undertaken to assess participant engagement and experience with SleepWise. Engagement was automatically tracked by SleepWise, which collected data on the date and time, pages viewed, and the number of goals and sleep logs completed per participant. Semistructured interviews were carried out to gain participant feedback. Participants in both trials reported high levels of acceptability (trial 1: mean 21.00, SD 2.74; trial 2: mean 20.82, SD 2.48) and demonstrated similar levels of engagement with SleepWise. Participants in trial 1 viewed slightly more pages of the intervention, and those in trial 2 achieved their set goals more frequently. Improvements in sleep quality were found in both trials 1 and 2, with medium (trial 1) and large (trial 2) effect sizes. A larger effect size for improvement in sleep quality was found in the nonincentivized trial (d=0.87), suggesting that incentivization may not impact engagement or sleep quality. Both trials achieved acceptable recruitment (trial 1, N=48; trial 2, N=42), and retention at 5 weeks (trial 1: N=30; trial 2: N=30). Qualitative findings showed that adolescents lead busy lifestyles, which may hinder engagement; however, participants deemed SleepWise acceptable in length and content, and made attempts at behavior change. SleepWise is an acceptable and potentially efficacious web-based sleep intervention aimed at adolescents. Findings from this study showed that incentivization did not greatly impact engagement, acceptability, or sleep quality. Subject to a full trial, SleepWise has the potential to address the urgent need for innovative, personalized, and acceptable sleep interventions for adolescents. OSF Registries osf.io/yanb2; https://osf.io/yanb2.

A feasibility study of the measurement of kaonic lead X-rays at DA[formula omitted]NE for the precise determination of the charged kaon mass

An HPGe detector equipped with a transistor reset preamplifier and readout with a CAEN DT5781 fast pulse digitizer was employed in the measurement of X-rays from kaonic lead at the DAΦNE e+e− collider at the Laboratori Nazionali di Frascati of INFN. A thin scintillator in front of a lead target was used to select kaons impinging on it and to form the trigger for the HPGe detector. We present the results of the kaonic lead feasibility measurement, where we show that the resolution of the HPGe detector in regular beam conditions remains the same as that without the beam and that a satisfactory background reduction can be achieved. This measurement serves as a test bed for future dedicated kaonic X-rays measurements for the more precise determination of the charged kaon mass.

Implementation of a genotyped African population cohort, with virtual follow-up: A feasibility study in the Western Cape Province, South Africa

Background There is limited knowledge regarding African genetic drivers of disease due to prohibitive costs of large-scale genomic research in Africa. Methods We piloted a cost-effective, scalable virtual genotyped cohort in South Africa, with participant recruitment using a tiered informed consent model and DNA collection by buccal swab. Genotype data was generated using the H3Africa Illumina micro-array, and phenotype data was derived from routine health data of participants. We demonstrated feasibility of nested case control genome wide association studies using these data for phenotypes type 2 diabetes mellitus (T2DM) and severe COVID-19. Results 2267346 variants were analysed in 459 participant samples. 78.6% of SNPs and 74% of samples passed quality control (QC). Principal component analysis showed extensive ancestry admixture in study participants. For 1780 published COVID-19-associated variants, 3 SNPs in the pre-imputation data and 23 SNPS in the imputed data were significantly associated with severe COVID-19 cases compared to controls. For 2755 published T2DM associated variants, 69 SNPs in the pre-imputation data and 419 SNPs in the imputed data were significantly associated with T2DM cases when compared to controls. Conclusions The results shown here are illustrative of what will be possible as the cohort expands in the future. Here we demonstrate the feasibility of this approach, recognising that the findings presented here are preliminary and require further validation once we have a sufficient sample size to improve statistical significance of findings. We implemented a genotyped population cohort with virtual follow up data in a resource-constrained African environment, demonstrating feasibility for scale up and novel health discoveries through nested case-control studies.

Evaluating the Effectiveness of a Large Language Model in the Psychological Assessment of Potential Liver Transplant Candidates: A Feasibility Study

Introduction: The use of artificial intelligence (AI) in medical settings has shown promise in various domains including diagnostics, treatment recommendation, and patient management. Recent advances have explored the potential of AI in pre-surgical assessments, but its application in transplant psychology remains unexplored. The objective of this study is to assess the effectiveness of AI in the context of screening potential liver transplant donors and recipients. To assess the feasibility of using ChatGPT-4 to screen potential liver transplant donors and recipients. Methods: This study utilizes a cross-sectional research design to evaluate the feasibility of using ChatGPT-4 in the preliminary screening of living liver donors and liver transplant candidates. The study aims to determine the accuracy and reliability of ChatGPT-4 in assessing hypothetical scenarios involving potential donors and recipients. Results: The analysis showed no found no significant differences between ChatGPT-4 and the expert panel in assessing liver transplant candidates, demonstrating an overall accuracy of 83.58%, sensitivity of 56.10%, and specificity of 80.49%. Additionally, the Cohen’s Kappa statistic of 0.68 (95% CI: 0.52-0.83) indicated substantial agreement between ChatGPT-4 and the psychologists’ evaluations. The absence of false positives (0%) and a low false negative rate (8%) emphasize ChatGPT-4's cautious and accurate decision-making capabilities. Conclusion: The findings of this study demonstrate that ChatGPT-4 has the potential to serve as an effective screening tool for liver transplant candidates, complementing the work of human experts and enhancing the overall efficiency of the transplant process. While challenges remain, the integration of AI into the liver transplantation workflow could lead to significant improvements in candidate evaluation and patient outcomes, paving the way for the broader application of AI in clinical practice.

Feasibility Evaluation of a Parenting Group for Latina Survivors of Intimate Partner Violence.

Intimate partner violence (IPV) is a pervasive concern among Latina women that requires accessible and culturally appropriate services for survivors, including programs to support parenting in the context of IPV. Evaluations of such programs are sparse, limiting understanding of how agencies can best serve Latina survivors who are parents. We conducted a feasibility study of a parenting group for Latina IPV survivors that included an analysis of administrative data, focus groups with program participants (n = 17), and interviews with facilitators (n = 4). Findings center on demand, acceptability, implementation, and recommendations. Overall, the program was well received, and results include suggestions to enhance the program.

A metaheuristic-based optimization model for flight procedure design

In recent years, the continuous increase in air traffic has led to a saturation of available airspace. The new localizer performance with vertical guidance (LPV) instrument approach procedures (IAPs) offer additional capacity at aerodromes and in airspaces. To support their implementation, a specifically developed model focused on the improved IAP design process and optimized solution generation is proposed. The model provides a fully automated search of the solution space by employing the bee colony optimization metaheuristic algorithm. The resulting list of alternatives is ranked by the objective function score, which is affected by the balancing values of the complexity indicators and the achieved obstacle clearance height. The model’s capabilities are successfully validated against the challenging operational environment of Podgorica Airport. The model was initially developed to conduct IAP feasibility studies; however, it can also be used in the initial stages of airport planning projects or for IAP criteria validation.

Psilocybin-assisted neurofeedback for the improvement of executive functions: a randomized semi-naturalistic-lab feasibility study.

Executive function deficits, common in psychiatric disorders, hinder daily activities and may be linked to diminished neural plasticity, affecting treatment and training responsiveness. In this pioneering study, we evaluated the feasibility and preliminary efficacy of psilocybin-assisted frontal-midline theta neurofeedback (NF), a neuromodulation technique leveraging neuroplasticity, to improve executive functions (EFs). Thirty-seven eligible participants were randomized into an experimental group (n = 18) and a passive control group (n = 19). The experimental group underwent three microdose sessions and then three psilocybin-assisted NF sessions, without requiring psychological support, demonstrating the approach's feasibility. NF learning showed a statistical trend for increases in frontal-midline theta from session to session with a large effect size and non-significant but medium effect size dynamical changes within sessions. Placebo effects were consistent across groups, with no tasks-based EF improvements, but significant self-reported gains in daily EFs-working memory, shifting, monitoring and inhibition-showing medium and high effect sizes. The experimental group's significant gains in their key training goals underscored the approach's external relevance. A thorough study with regular sessions and an active control group is crucial to evaluate EFs improvement and their specificity in future. Psilocybin-enhanced NF could offer significant, lasting benefits across diagnoses, improving daily functioning. This article is part of the theme issue 'Neurofeedback: new territories and neurocognitive mechanisms of endogenous neuromodulation'.

Virtual Reality-Based Exposure With 360° Environments for Social Anxiety Disorder: Usability and Feasibility Study.

Social anxiety disorder (SAD) is a long-term and overwhelming fear of social situations that can affect work, school, and other daily activities. Although cognitive behavioral therapy is effective, few seek treatment, and many who do start often drop out. This may be due to the component of exposure inherent to cognitive behavioral therapy, where the patient confronts feared stimuli outside the therapist's office, which they otherwise try to avoid. As an alternative, research has explored the effectiveness of virtual reality (VR)-based exposure therapy with promising results. However, few studies have investigated the feasibility of VR tools using mixed methodologies before assessing their efficacy. This study aims to assess the usability, feasibility, and presence of four 360° virtual environments and whether these were able to evoke anxiety in patients with SAD. A total of 10 adult participants with SAD and 10 healthy controls were recruited for 1 experimental session (age range 21-32 y; 12/20, 60% male participants). Questionnaire and interview data were collected and analyzed. A mixed methods triangulation design was applied to analyze and compare the data. Participants with SAD experienced increased anxiety when exposed to VR, and environments were considered relevant and useful as an exposure tool. Participants with SAD reported significantly higher average anxiety levels (P=.01) and peak anxiety levels (P=.01) compared with controls during exposure; however, significant differences in anxiety when accounting for baseline anxiety levels were only found in 2 of 4 environments (P=.01, P=.01, P=.07, and P=.06). While presence scores were acceptable in both groups, participants with SAD scored significantly lower than controls. Qualitative analyses highlight this finding within the SAD group, where some participants experienced presence reduction due to being observed while in VR and in situations with reduced interaction in VR. VR exposure with 360° videos seems to be useful as a first step of exposure therapy for patients with SAD. Future exploration in the clinical application of VR-based exposure for SAD, as well as means of increasing presence within the virtual environments, may be useful.

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.

The development of a tool for GPs to manage overweight and obesity in children: A Delphi study

Background General practitioners (GPs) could play an important role in the management of overweight and obesity in children. However, GPs experience different barriers and are in need of supportive tools. In order to support GPs to identify, address and refer these children, new tools should be developed. Objective To establish consensus among GPs about the content topics of a supportive tool to identify, address and refer children with overweight and obesity in general practice. Methods A two-round Delphi study was conducted with GPs identified as experts. A concept of a supportive tool was constructed based on focus-group interviews with GPs, practice nurses and parents of children with and without overweight and literature. The tool was categorised into five topics: identifying, initiating and continuing weight-related conversations, referring and evaluating a tool manual. GPs evaluated statements on the tool’s topics in terms of importance. All statements were rated on a 5-point Likert scale and consensus was set at ≥70% of respondents agreeing with the statements. Results GPs agreed that a supportive tool must contain a child’s specialised BMI calculator; examples to initiate and to continue weight-related conversations with parents and children; a map with available interventions; and a manual including information and resources about health risks of overweight and obesity during childhood. Conclusion The content topics of a supportive tool for GPs to identify, discuss and refer children with overweight and obesity were determined through a consensus-driven process. Further validation and assessment are required through a feasibility and implementation study.

Feasibility and pilot study of Indonesia’s first telehealth support program for gynecological cancer survivors undergoing chemotherapy

Most Indonesian gynecological cancer survivors experience chemotherapy side effects on their physical and mental health as they face unmet needs of supportive care, which increases the likelihood of discontinuing treatment. Interventions in telehealth assist survivors in resolving these issues. The aim of this pilot study was to determine the feasibility of fighting distress, self-efficacy, health effects, and sexual (FoRSHE-X) interventions and evaluate their potential impact on distress level, side effects knowledge and management, self-efficacy, and sexual quality of life. The study involved gynecological cancer survivors who underwent chemotherapy and participated in ten weeks of individual social media-based education, tele-coaching, and teleconsultations, from September 2023 to June 2024. The study feasibility and pilot outcomes were evaluated using descriptive statistics and qualitative thematic analysis. Of the twelve women recruited, six (50%) completed the study, filled out pre- and post-intervention questionnaires, and participated in interviews. Fifty-four virtual education, coaching, and consultation sessions were performed individually. The statistical results indicated that participants were highly satisfied with the telehealth program, which significantly increased their knowledge (p=0.02), health practices (p=0.04), and self-efficacy (p=0.01). The qualitative analysis highlighted participants' and coaches' perspectives on the study’s acceptance, barriers, and recommendations. In conclusion, this pilot study suggests that a definitive trial to assess the FoRSHE-X interventions is feasible, acceptable, and can be applied not only to gynecological cancer survivors but also to other types of cancer, thereby broadening the potential impact of the study.

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.

Strengthening implementation of integrated care for small and nutritionally at-risk infants under six months and their mothers: Pre-trial feasibility study.

An integrated care pathway to manage small and nutritionally at-risk infants under 6 months (u6m) and their mothers (MAMI Care Pathway) is consistent with 2023 WHO malnutrition guidelines and is being tested in a randomised controlled trial (RCT) in Ethiopia. To optimise trial implementation, we investigated contextual fit with key local stakeholders. We used scenario-based interviews with 17 health workers and four district managers to explore perceived feasibility. Eighteen policymakers were also surveyed to explore policy coherence, demand, acceptability, evidence needs, opportunities and risks. The Bowen feasibility framework and an access to health care framework were adapted and applied. Health workers perceived the MAMI Care Pathway as feasible to implement with support to access services and provide care. The approach is acceptable, given consistency with national policies, local protocols and potential to improve routine care quality. Demand for more comprehensive, preventive and person-centred outpatient care was driven by concerns about unmet, hidden and costly care burden for health services and families. Inpatient care only for severe wasting treatment is inaccessible and unacceptable. Support for routine and expanded components, especially maternal mental health, is needed for successful implementation. Wider contextual factors may affect implementation fidelity and strength. Policymakers cautiously welcomed the approach, which resonates with national commitments, policies and plans but need evidence on how it can work within varied, complex contexts without further system overstretch. A responsive, pragmatic randomised controlled trial will generate the most useful evidence for policymakers. Findings have informed trial preparation and implementation, including a realist evaluation to contextualise outcomes.