To explore the perspectives and experiences related to caring for older people during clinical placement among undergraduate nursing students.

A qualitative exploratory study analysing individual interview data.

Department of Nursing, Faculty of Allied Health Sciences, University of Peradeniya, Sri Lanka.

Participants: A purposive sample of 14 undergraduate nursing students.

Semi-structured in-depth interviews were conducted, audio-recorded and transcribed. Data were analysed using Braun and Clarke’s reflexive thematic analysis framework.

Five themes emerged: (1) understanding ageing: The concept of ‘Age’, (2) Complexity of care: navigating challenges, (3) Care provision: rewards, growth and fulfilment, (4) Addressing challenges: barriers to support and (5) Reaching the horizon: enhancing geriatric education. Nursing students encountered both positive and negative experiences related to caring for older people. Positive experiences included increased self-awareness, learning opportunities, skill development and personal satisfaction. Negative experiences involved student-related and patient-related challenges, initial difficulties in providing care and inadequate support and mentoring during clinical placements.

Despite the complexities of caring for older people, nursing students are motivated to learn and provide the necessary care. This study highlights the need for quality care for older people, the importance of early geriatric education and the need for enhancing clinical supervision and mentoring.

About 30% of depressed patients suffer from a protracted course in which the disorder continues to cause significant burden despite treatment efforts. While originally developed for relapse prevention, mindfulness-based cognitive therapy (MBCT) has increasingly been investigated in depressed patients with such ‘difficult-to-treat’ courses. This is a protocol for an individual participant data (IPD) meta-analysis aiming to determine efficacy and potential moderators of MBCT treatment effects in this group based on evidence from randomised controlled trials.

Systematic searches in PubMed, Web of Science, Scopus, PsycINFO, EMBASE and the Cochrane Controlled Trials Register for randomised controlled trials were completed on 17 June 2024. Authors of identified studies have contributed IPD, and data extractions have been completed. An update search will be conducted immediately before the start of data analyses. We will investigate the following outcomes: (a) self-reported and observer-reported severity of depression symptomatology, (b) remission and (c) clinically meaningful improvement and deterioration. One-stage and two-stage IPD-MA will be conducted with one-stage models using the observed IPD from all studies simultaneously as the primary approach. One-stage IPD models will include stratified study intercepts and error terms as well as random effects to capture between-study heterogeneity. Moderator analyses will test treatment-covariate interactions for both individual patient-level and study-level characteristics.

The results will inform understanding of the use of MBCT in patients with current ‘difficult-to-treat’ depression and will contribute to arguments in favour of or against implementing MBCT as a treatment for this group. They will be published in a peer-reviewed journal and made available to stakeholders in accessible formats. No local ethical review was necessary following consultation with the Ethics and Governance Board of the University of Surrey. Guidance on patient data storage and management will be adhered to throughout.

CRD42022332039.

To assess maternal medical conditions, physical and surgical ailments, contraceptive use and barriers to its use, maternal mental health, neonatal health, breastfeeding practices and available social support in the postpartum period.

A prospective cohort study.

A large tertiary care centre.

12 245 women who delivered after 22 weeks gestation in the year 2022.

Three pre-specified exposures, namely mode of delivery, presence of significant risk factors and preterm delivery within the cohort, were used to identify potential groups of women who would need additional support.

The primary outcome was the number of unscheduled visits by the mother or child and the indications for these visits.

The secondary outcomes in mothers included unhealed wound sites, anaemia, increase in body mass index (BMI) by >3, persistent high blood pressure, pain in the abdomen or pelvis, urinary or bowel problems, musculoskeletal pain, abnormal maternal mental health, breast-related issues and barriers to breastfeeding, contraceptive use and sexual activity.

Only 2% of women and children were lost to follow-up. Nine women and 75 babies died. The majority of infant deaths were related to serious congenital diseases. Unscheduled visits to the health facility were seen in 44% of the cohort, most commonly for upper respiratory infections and fever in the mother and baby. 41 mothers and 741 infants needed admission to hospital. Hospitalisation was more common in those with risk factors or preterm delivery. High blood pressure was seen in 3 to 4% and anaemia in 4% of the cohort. Wound infection was seen in 3 to 4% and urinary incontinence in 2% of women. Wound infection was more common with instrumental delivery. Bowel incontinence was rare. A fourth of the cohort had musculoskeletal pain, especially back pain, which was more common after caesarean delivery. Only 5.5% of the cohort had unsatisfactory mental health, and these women were more likely to have abnormal mental health scores with the NICE Questionnaire at screening. The family APGAR of the cohort was 9/10, and 95% belonged to the middle-income group. 2.6% of neonates had delayed milestones, and this was more common in the group with risk factors and preterm delivery.

Healthcare utilisation was mainly for minor complaints. Re-admissions were rare, as intrapartum and immediate postpartum care were optimal. Women who delivered by caesarean section or delivered a preterm child needed additional support in the postpartum phase. NICE Questionnaire is a quick and easy screening tool to identify unsatisfactory mental health and should be used before discharge, postnatally, even in busy settings. The implementation of formal telephonic support 24 hours a day in birthing facilities should be explored in the future. Holistic postnatal care of mother and child during the immunisation of the baby would be the best opportunity to improve the quality and coverage of care in the postnatal phase.

CTRI/2022/03/041343.

In low-income and middle-income countries, significant geographical and socioeconomic inequalities affect access to eye care. This study explores an equity-focused approach to improve access to eye care services provided by a community-based eye care organisation in northern India.

A sequential exploratory mixed-method approach.

A high-volume eye screening programme in north Indian villages. Individuals identified with eye care needs during the screening were referred to the six nearby primary eye care centres.

7578 individuals identified with eye needs through a community-based eye screening programme. Of these, 4431 (58.6%) were women and 3137 (41.4%) were men.

Socioeconomic questions, developed by experts and lay representatives, were integrated into an ongoing digitally supported (Peek Vision) eye screening programme in north Indian villages. Data from referred individuals identified with eye needs were analysed using logistic regression with a mixed-effect model to identify socioeconomic characteristics most strongly associated with poor access to care after referral. A sequential exploratory mixed-method approach, including in-person interviews and follow-up telephonic surveys of individuals with these characteristics, was used.

To identify barriers and gather suggestions for improving attendance from groups least likely to attend services.

Of 7627 individuals referred for eye care, 7578 (99.3%) participated in the study. Of those, 2937 (38.5%) attended the Vision Centre, to which they were referred. The least likely to attend were individuals aged >16, those with dependents, and those referred for non-cataract conditions. Among the 3939 individuals with all three characteristics, the attendance rate was 35.3% compared with 42.5% (p

Suggested programme improvements, including better counselling, reminder calls and transportation, could increase access among those least likely to access services after referral. This study demonstrates a two-step approach for identifying solutions from individuals facing the most significant barriers to care. We will go on to conduct trials of these suggested interventions.

Practice guidelines recommend addressing patient non-medical drivers of health such as access to nutritious food and transportation as part of whole-person care. Emergent electronic health record (EHR)-based tools can enable non-medical needs care coordination, but adoption commonly faces workflow and infrastructure barriers. Targeted implementation support strategies (eg, training, practice facilitation) can enhance technology adoption in healthcare settings, but no prior research has assessed if implementation strategies can improve how care managers use enabling technologies for non-medical needs care coordination. This study will test whether providing implementation support to primary care health centre care management teams improves the adoption of EHR-based enabling technologies to address patients’ non-medical needs.

This hybrid implementation-effectiveness type 2 pragmatic trial has a mixed methods design. The primary outcomes include: (1) Whether patients enrolled in care management programmes have been screened for unmet non-medical health-related needs and (2) Whether patients with identified unmet non-medical health-related needs received a referral to a community organisation to address their need. The secondary outcomes include: (1) Whether referrals for financial-related non-medical needs had a documented outcome in the EHR, such as successful connection to services, service unavailability or other disposition statuses, (2) Whether the referral outcomes indicated ‘successful connection to services’ and (3) Clinical markers including hypertension and diabetes control. Formative evaluation of barriers and facilitators to using EHR tools to conduct non-medical needs screening, referrals and tracking of receipt of services will include semi-structured interviews and a ‘guided tour’ of enabling technology used by care managers. A modified Delphi process will then inform the development of a set of implementation strategies for inclusion in the intervention. The intervention will be piloted in three health centres, refined, then tested in a stepped-wedge cluster-randomised trial in 20 health centres.

We obtained ethics approval for all study activities from Advarra Institutional Review Board (registration number #00000971). Results will be disseminated to Health Centres and Health Centre network nationally at meetings and we will disseminate to researchers via manuscripts in peer-reviewed journals and scientific meetings.

NCT06489002.

With the rapid increase in the number of older adults living with chronic diseases and disabilities, there is a growing need to prepare nurses with positive attitudes and a willingness to work with older adults. This study aims to examine attitudes towards and willingness to work with older adults among nurses.

A cross-sectional survey was conducted among a purposive sample of 267 nurses at the University Hospital of Kotelawala Defence University, Sri Lanka. Participants completed a self-administered questionnaire consisting of socio-demographic variables, Kogan’s Attitudes Toward Old People Scale and questions related to willingness to work with older adults. Descriptive statistics and linear and logistic regression analyses were used in data analysis.

The majority were female nurses (71.9%, n=192) and held slightly negative (58%, n=155) or slightly positive (41.9%, n=122) attitudes towards working with older adults. Only 35.2% (n=94) were willing to work with older adults in this study. A male nurse (beta coefficient (β)=4.644, CI 2.392 to 6.896, p

Most nurses express slightly negative to positive attitudes and have little interest in working with older adults. Various socio-demographic factors have an impact on attitudes towards and willingness to work with older adults. Since nurses play a significant role in providing care for older adults, the development of positive attitudes is essential, and interventions and strategies are crucial to increasing their willingness to work with older adults.

To understand experiences of stigma and discrimination among adults who are homeless across multiple care and support system contexts.

Cross-sectional survey embedded within an ethnographic case study.

South London, UK, 2024.

Convenience sample of 74 people experiencing homelessness, aged over 18 years.

Participants most commonly reported unfair treatment in public settings (85%), legal settings (72%), housing and homelessness services (68%) and health settings (65%). These experiences were attributed to a range of factors and identities, with homelessness the most commonly cited; people commonly linked unfair experiences to multiple identities. People with more comorbidities reported experiencing unfair treatment across more system settings, including and beyond health systems.

Unfair treatment was reported across multiple care and support systems with greater ill-health associated with more unfair treatment. Future larger-scale surveys should measure the extent of stigma and discrimination across the population.

Inhaled anaesthetics can be used in mechanically ventilated critically ill patients to provide sedation. This approach to sedation potentially improves patient and health system outcomes, but further supportive evidence is needed. The objective of the SAVE-ICU clinical trial is to compare the effectiveness of inhaled versus intravenous sedation in ventilated adults with acute hypoxaemic respiratory failure.

SAVE-ICU is a multicentre, open-label, pragmatic, randomised controlled trial conducted in 15 intensive care units (ICUs) in Canada and the USA. Eligible patients include mechanically ventilated and sedated adults with acute hypoxemic respiratory failure from COVID-19 or non-COVID causes with PaO₂/F_IO₂ ratio 12 hour). A hierarchy of outcomes was identified at the time of trial design, as the trial was launched during the COVID-19 pandemic when study drug shortages, staffing challenges and healthcare system pressures were prevalent and there was a requirement for rapid evidence generation and implementation on this topic. The primary outcome and highest in the hierarchy is hospital mortality (requiring 758 participants). Secondary and lower hierarchical outcomes are ventilator-free days at day 30 (200 patients), quality of life at 3 months (144 participants) and ICU-free days at day 30 (128 participants). Additional secondary outcomes include median daily oxygenation at day 3 (PaO₂/F_IO₂ ratio), need for adjunctive acute respiratory distress syndrome therapies (prone positioning, inhaled nitric oxide, paralysis with a neuromuscular blocking agent and extracorporeal membrane oxygenation) during ICU stay, days alive and free from delirium and coma at day 14, hospital-free days at day 60 and disability score at 3 months and 12 months after enrolment.

The protocol was approved by all hospital ethics committees and by Health Canada. Informed consent will be obtained from substitute decision makers or deferred consent (as permitted by site ethics board). Trial findings will be shared at the end of the study using peer-review publications, conference presentations and social media as part of the trial knowledge translation plan.

NCT04415060.

Nicotine vaping is common among children and youth, and even more so among those with mental health concerns. Identifying and managing nicotine vaping in child and youth mental health treatment settings is key to addressing this modifiable risk factor for poorer physical and mental health in young people. Recommendations exist for screening, assessment and treatment of youth vaping; however, it remains unclear whether current practices in child and youth mental health programmes align with recommended standards.

An explanatory sequential mixed methods design with three stages will be employed. In the first stage, a cross-sectional survey will be distributed to all eligible Canadian hospitals to identify practices in assessment and treatment of nicotine vaping within their child and youth mental health and addictions programmes. This survey will also assess barriers and facilitators for the uptake of the 2021 Canadian Paediatric Society recommendations on management of youth vaping. Semi-structured focus groups and interviews will be conducted in stage two, with clinicians, managers, youth and caregivers. Qualitative data will be analysed using a reflexive thematic approach. In stage three, findings and proposed behaviour change interventions will be reviewed at a knowledge mobilisation meeting with the goal of developing a national knowledge mobilisation plan to improve assessment and treatment of youth vaping in hospital-based mental health and addictions programmes.

This study has received ethics approval from the Research Ethics Board at the Children’s Hospital of Eastern Ontario (Protocol #25/19X). Participants will provide informed consent prior to participating. Results will be published in peer-reviewed journals and presented at scientific conferences. Summaries will be provided to the funders of the study and to participating hospitals.

Suicide poses a significant global health challenge in low- and middle-income countries and is a leading cause of death worldwide. Although global suicide rates have decreased by 36% between 2000 and 2019, the decline in Africa has not been as substantial. Suicide surveillance data, particularly from pesticide ingestion, is lacking.

This scoping review aimed to identify pesticide suicide surveillance methods currently used in African countries and to assess their viability for improving reporting of pesticide suicide deaths.

A scoping review was conducted using a five-stage methodological framework across several databases.

Peer-reviewed articles published in English that investigated (a) pesticide poisoning and (b) suicide in humans only and specific to the African continent.

MEDLINE (via PubMed), Scopus (with substantial Embase content), Web of Science Core Collection, Biological Abstracts, SciELO (on Web of Science platform), Academic Search Premier, Africa-Wide Information, Biological and Agricultural Index, CINAHL, Health Source Nursing/Academic, APA PsycInfo and General Science (EBSCOhost platform). The search was performed in January 2022, and the review of the results took place from February to May 2022.

All authors developed and tested the data extraction tool. The charting framework remained dynamic, continuously updated as reviewers gained a deeper understanding of the studies included. Four independent reviewers charted the data to ensure inter-rater reliability. To address discrepancies, a sample of eligible articles was cross-rated by the reviewers.

We identified 110 relevant studies describing eight different surveillance systems, conducted in 30 different African countries. Of these studies, 50.1% (56/110) reported on the number of pesticide suicides (totalling 1554); however, 49% (54/110) did not differentiate the cause of death further than either a poisoning death or a suicide, making it difficult to determine if pesticides were involved in the death or if the death was an intentional poisoning case. The surveillance systems identified included health facility records (hospital admissions data), poison control centre (PCC) data, forensic/mortuary data (including police reports), media reports, surveys/interviews with patient/family, case reports, systematic/literature reviews and civil registration and vital statistics (CRVS) data. Hospital admissions data was the most frequently used surveillance system (61/110, 55.5%).

The number of studies and surveillance methods found was higher than anticipated. While this is a positive sign, several areas of improvement were identified for pesticide suicide surveillance in Africa. These included improving reporting of the specific pesticides (including the active ingredient) linked to suicide cases for improving policy (since this is required for pesticide regulation) and making use of more than one surveillance system to enhance surveillance of pesticide suicides, allowing for under-used sources, such as PCCs, to be used more effectively in pesticide suicide surveillance. Finally, although a comparison of these surveillance methods outside of Africa was not directly possible for each surveillance system due to a lack of similar high-quality reviews, we did refer to publications where similar pesticide suicide surveillance systems were discussed.

People in rural areas of Australia experience poorer health in almost every indicator compared with urban populations; however, rural communities have lower access to primary health, allied health and specialist healthcare. Timely access to care is compounded by persistent and widespread health workforce issues, including attracting and retaining staff.

Australian University Departments of Rural Health (UDRH) have been established to address the needs of rural populations with the goal of improving recruitment and retention of health professionals across rural and remote Australia. The work-integrated learning team within The University of Melbourne works with nursing and allied health university students on clinical placement to provide exposure to working in rural health, with a remit to build the capacity of the existing and future workforce. The service-learning model aims to provide reciprocal benefits to stakeholders through purposefully co-designed placements that respond to rural health needs by providing services to underserved communities and ensuring university students are exposed to real world, diverse practice settings.

The overarching aim of this project is to determine the impact of the SL programme for key stakeholders, predominately end users and those stakeholders involved in the delivery of the SL model. The key stakeholders are host site staff, allied health university students, allied health supervisors and the end users of the programme. End users are those individuals that have received allied health services through the programme, such as clients, residents and children.

This study will adopt a convergent mixed methods methodology underpinned by a RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance)/PRISM (Practical, Robust Implementation Sustainability Model) approach. Data collection will include document review, existing programme data review and primary data collection. This will involve conducting surveys and interviews with allied health university students, host organisations and allied health supervisors, and interviews with adult recipients of the service-learning programme. Art-based consultation will be conducted with school-aged children recipients of the service-learning programme. Analysis will be underpinned by the RE-AIM/PRISM framework to inform programme learnings and impact for key stakeholders.

This study has been approved by the University of Melbourne Human Research Ethics Committee (Project ID: 30409).

Findings will be published in a stakeholder project report and peer-review journals in the fields of rural health, implementation science and work integrated learning.

Patients receiving long-term ventilation (LTV) in out-of-hospital intensive care facilities often suffer from persistent impairments of their cognition, mental health and physical health, limiting their social participation. Chronically ill patients are often unable to express their care preferences. Thus, their medical care often lacks integration of patients’ wishes and values. Telemedicine may be used to collect patient-reported outcome measures (PROMs) from these patients to align medical care with their preferences. Early integration of teleconsultation to provide rapid support for specific patient symptoms can reduce economic costs.

This is a multicentre, prospective, non-blinded, single-arm interventional trial with a pre-post design and follows the Standard Protocol Items: Recommendations for Interventional Trials statement. 10 out-of-hospital intensive care facilities in Berlin and Brandenburg, Germany, are grouped into three clusters. The study population includes adult patients (≥18 years) receiving LTV and residing in participating care facilities. During the preintervention phase, standard patient care remains unchanged. From the start of the intervention phase, enrolled patients receive telemedicine rounds in addition to standard care. These telemedicine rounds, conducted at least weekly, involve on-site healthcare professionals, patients and their relatives. Data are collected at predefined time points—study months 1,3, 9, 15 and 21—with a target of 57 participants at each time point. The study aims to evaluate whether a structured telemedicine intervention (1) increases the proportion of patients receiving record-documented PROMs in routine care and (2) reduces hospital readmissions. Secondary outcomes include the evaluation of post-intensive care syndrome, healthcare costs and the usability, applicability and perceived benefits of telemedicine. Additionally, qualitative interviews with patients, their relatives and healthcare professionals will explore individual experiences with chronic critical illness, the perceived quality of life of the patients and how team members manage moral distress in caregiving contexts. A mixed-effects logistic regression model will be used to analyse patients’ access to PROMs, while a mixed-effects Poisson regression model will be employed to evaluate hospital readmission rates. The findings may provide valuable insights into how telemedicine can improve patient-centred care for this particular patient group.

This study protocol received approval from the Ethics Committee of Charité—Universitätsmedizin Berlin, Germany (EA2/136/22). The findings will be disseminated through publication in a peer-reviewed scientific journal and presented at international conferences.

This study was registered in the ‘German Register of Clinical Studies’ (DRKS; DRKS00029326).

Perioperative adverse events increase morbidity and mortality. The rate and severity of complications and the risk for subsequent mortality are increased after high-risk procedures and in elevated-risk patients. Over the past decades, a multitude of prognostic studies identified perioperative risk factors at the population level. However, to allow for the advancement of precision surgery strategies, improved risk prediction on the individual patient level is warranted. Comprehensive, consecutive, multisource, structured, high-quality patient-related and procedure-related data sets, together with thorough follow-up and combined with state-of-the-art machine-learning analyses, are needed to facilitate precise prediction of perioperative complications. Therefore, we designed and currently conduct the Heidelberg Perioperative Deep Data study (HeiPoDD). Here, we report the rationale and design of the HeiPoDD study.

HeiPoDD is a prospective, single-centre, exploratory cohort study aiming to build up a large-scale deep-data base and corresponding biomaterial collection. 1040 adult patients planned for elective high-risk, non-cardiac surgery for any indication at Heidelberg University Hospital, Germany will be included. The obtained study-specific data set includes clinical data, lab values, genome- and proteome analysis as well as plasma, serum and peripheral blood mononuclear cells (PBMC) collected before and at days 1, 3 and 7 postsurgery. Urine samples are collected before and at day 1 postsurgery. Structured follow-up for perioperative complications such as redo-surgery, length of intensive care stay or length of hospital stay is conducted at days 30, 90 and 1 year postsurgery and for disease progression and survival after 3 and 5 years postsurgery. All study data will be transferred to the HeiPoDD registry to allow merging with all available routine clinical data from the hospital information system including imaging studies as well as haemodynamic and respiratory biosignals. Biomaterials will be stored in the HeiPoDD biomaterial bank to allow further analyses.

The trial protocol and amendments were approved by the ethics committee of the University of Heidelberg (S-758/2021). The protocol is registered with the German Clinical Trial Register (DRKS00024625). Participating patients’ data will be recorded only in pseudonymised form. After completion of the study, data collected during the study will be kept on file for up to 30 years. Biomedical samples collected during the study and entered into the biobank will be held for the same amount of time. The findings will be disseminated in peer-reviewed academic journals.

Haematuria contributes significantly to emergency urology admissions with over 4 per 1000 annual UK emergency admissions and 10% readmitted within 30 days. However, there is limited focus on optimising inpatient pathways internationally. Existing studies highlight a substantial underlying malignancy rate (32%) in patients presenting with visible haematuria, yet many receive inconsistent care, leading to prolonged hospital stays and increased resource use. A systematic review performed by our research group found no large-scale prospective studies have been performed in this area, and little is known about current practice. This study aims to address these gaps by investigating current management practices and their impact on outcomes, with the goal of informing evidence-based guidelines and improving patient care.

The Ward AdmiSsion of Haematuria: an Observational mUlticentre sTudy is an international, multicentre prospective observational study designed to describe the management of patients with unplanned admission to hospital with haematuria under the care of the urology team. The study will use a collaborative methodology using the British Urology Researchers in Surgical Training model. This model delivers international multicentre studies by empowering trainees to lead all aspects of multi-centre clinical studies, building research skills cost-effectively while shaping the future urological consultant workforce. Data on demographics, comorbidities, management practices and outcomes will be collected using a standardised case report form and analysed using multilevel linear regression modelling. Primary outcomes include length of stay, while secondary outcomes cover hospitalisation free survival, mortality, readmission rates at 90 days and resource use. The study was launched in January 2024 and will continue follow-up data collection through December 2025. Patient and public involvement (PPI) has been integral to the study design, ensuring that outcomes reflect patient priorities and that the research addresses key areas of concern.

Ethical and regulatory approvals will be obtained as required in each participating region. In the UK, the study is classified as a service evaluation and does not require individual patient consent. Participating sites must obtain local audit department approval. Data will be collected and stored securely, ensuring patient confidentiality. Results will be disseminated through scientific conferences, peer-reviewed publications and patient advocacy groups.

Patients with metastatic oncogene-driven non-small cell lung cancer (NSCLC) are experiencing longer and uncertain trajectories of life-limiting illness due to advances in precision medicine. These advanced cancer survivors face new challenges related to living with uncertainty and desire more support to maximize their health and quality of life. Therefore, we developed a population-specific, blended palliative and survivorship care intervention to address the supportive care needs of patients recently diagnosed with advanced lung cancer and who are receiving targeted therapy for NSCLC with EGFR, ALK, ROS1 or RET driver mutations.

This study is a single-site, non-blinded pilot randomised controlled trial of an intervention for patients with metastatic oncogene-driven NSCLC, Patient-centred, Optimal Integration of Survivorship and palliative carE (POISE) versus usual care. POISE consists of a brief series of structured visits with a trained palliative care clinician to address coping with uncertainty, increase prognostic awareness and promote healthy lifestyle behaviours. We will recruit 60 patients from the Massachusetts General Hospital Cancer Center. Patients will be randomised into a 1:1 ratio to the intervention arm or the usual care arm. Patients randomised to the intervention arm will complete four 60 min virtual or in-person visits with a palliative care physician. The usual care arm will receive standard oncology care. Patients in both arms will complete survey assessments at enrolment, 12 weeks and 20 weeks after enrolment, and patients in the intervention group will complete an exit interview. The primary outcome measure of this trial is feasibility, which will be defined by ≥60% enrolment among eligible patients, ≥70% completion of all sessions for participants in the intervention arm and ≥70% completion of all surveys for all study participants. Exploratory outcomes include acceptability, emotional coping with prognosis, self-efficacy for chronic disease management, prognostic awareness, quality of life, anxiety, depression, intolerance of uncertainty and documentation of goals and values discussions in the electronic health record.

This study was approved by the Dana-Farber/Harvard Cancer Center’s institutional review board (protocol 20-722). The protocol is reported in accordance with the Standard Protocol Items: Recommendations for Interventional Trials guidelines, and the study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials.

NCT04900935.