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Phase II randomised controlled basket feasibility trial of a personalised, remotely delivered exercise programme on disease-free survival among early-stage, high-risk cancers: CANFit study protocol

Por: Bullock · A. F. · Cohen · J. · Huang · C. · Jackson · G. · Lind · M. · Pearson · M. · Richardson · G. · Saxton · J. · Twiddy · M. · Wilson · C. · Forbes · C.
Introduction

Evidence suggests a 38% risk reduction in breast and bowel cancer-specific mortality with higher levels of exercise, however, most of this evidence is observational. More clinical trials are needed to build strong evidence for exercise’s impact on recurrence and survival. This study aims to assess the feasibility, acceptability and potential efficacy of a remote, tailored exercise programme on disease-free survival in patients recently completing curative treatment for early-stage, high-risk lung, breast or bowel cancer.

Methods and analysis

This UK-based, multicentre randomised controlled basket feasibility trial compares a personalised, remote-delivered exercise programme supported by exercise professionals against usual care. Potential participants are approached if they are: aged 18 or over, diagnosed with high-risk, early-stage breast, bowel or lung cancer, and within 24 weeks of completing primary curative treatments. Participants complete objective measures of physical function (submaximal cardiovascular fitness, endurance, muscle strength and balance), body composition (bioelectrical impedance) and self-reported outcomes (total physical activity, sleep quality, general quality of life (QoL), cancer-related QoL and exercise confidence/motivation). Clinical case note review provides disease-free survival outcomes at 6, 12 and 24 months. The 12-week programme is delivered remotely (via phone, email and/or video conference) with trainer contact tapering off over the subsequent 12 weeks (24 weeks total). Recruitment is ongoing with a 660-participant goal. Descriptive measures (quantitative and qualitative) will be reported for feasibility outcomes: recruitment, adherence, retention rates, data collection quality, adverse events, intervention acceptability and fidelity. A process evaluation is being conducted concurrently and is reported separately. Kaplan-Meier curves will be plotted and median disease-free survival calculated for each arm. To determine intervention impact, a log-rank test (unadjusted) will compare 2-year disease-free survival between groups within and among cancer types. Secondary outcomes (physical function status, general/cancer-specific QoL and determinants of meeting activity guidelines) will be reported at each time point.

Ethics and dissemination

Ethical approvals were obtained through Hull York Medical School (ID: 23/SS/0060) and UK NHS Health Research Authority (ID: 327663). Findings will be submitted for publication in high-impact journals, presentation at national and international conferences, press releases where appropriate, and dissemination activities to be decided on with the Patient Advisory Group.

Trial registration number

ISRCTN97662203.

Constructive Resistance: Essential to Optimise Workplace Quality

Journal of Advanced Nursing, Volume 81, Issue 10, Page 6071-6073, October 2025.

Structural Resilience Across the Life Course: Perspectives From Older Adults Racialized as Black

ABSTRACT

Aim(s)

This study explored perceptions of older adults racialised as Black on structural resilience across the life course.

Design

A qualitative descriptive study.

Methods

Using purposive sampling, we recruited 15 Black adults aged 50 and older residing in Baltimore, Maryland, including individuals possessing historical or current knowledge of the community. Semi-structured interviews were conducted to elicit participants' experiences with structural resources during childhood, adulthood and late adulthood. Interviews were audio-recorded, transcribed verbatim and analysed using content analysis.

Results

Of the 15 participants, three identified as male (20.0%) and 12 as female (80.0%), with an average age of 70.9 ± 8.2 years. The analysis identified nine categories of structural resilience, confirming its multifaceted and dynamic nature. Common categories present across all life stages included: Built environment, civic engagement, food and housing, healthcare, and social capital and cohesion. Life stage–specific categories included child and family services, educational supports, and workforce development supports during childhood and adulthood, and financial support during adulthood and late adulthood.

Conclusion

These categories were interdependent and spanned across life stages, illustrating the dynamic, cumulative and relational qualities of structural resilience. Furthermore, structural resources were identified as key to safeguarding, empowering and restorative responses to adversity.

Impact

These findings contribute to the development of a nuanced, life course–informed framework of structural resilience and highlight the need for ecological strategies that address structural forces shaping health and well-being, particularly among older adults racialised as Black.

Reporting Method

This study was reported in accordance with the Consolidated Criteria for Reporting Qualitative Research checklist.

Patient or Public Contribution

No patient or public contribution.

Community Nurses' Experiences Assessing Early‐Stage Pressure Injuries in People With Dark Skin Tones: A Qualitative Descriptive Analysis

ABSTRACT

Aim

To examine community nurses' experiences of caring for people with dark skin tones at high risk of developing a pressure injury.

Design

Qualitative descriptive design.

Methods

Focus groups and individual semi-structured interviews were conducted among registered nurses working in the community between November 2023 and March 2024. Thematic analysis was used.

Results

The findings reveal the lack of nurse education on diverse skin tones, how community nurses gain knowledge on skin tone diversity in the context of pressure injuries and the topics community nurses believe are crucial to improve the management of pressure injuries in patients with dark skin tones.

Conclusion

The study highlights the gap in nurse education regarding diverse skin tones, revealing how community nurses acquire knowledge related to pressure injuries in patients with dark skin tones.

Implications for the Profession and/or Patient Care

This research could inform the development of targeted educational programmes and training initiatives, ultimately preventing patient harm and enhancing the quality of care and health outcomes for patients with dark skin tones.

Impact

It provides valuable insights into key topics that community nurses consider essential for improving the early recognition and management of pressure injuries in people with darker skin tones.

Reporting Method

The research adhered to the Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines.

Public Contribution

A project steering group contributed to the concept of the study and checked the interview questions were relevant and suitable.

Blended palliative and survivorship care intervention (POISE) for patients with metastatic oncogene-driven non-small cell lung cancer: study protocol for a pilot randomised controlled trial

Por: Richard · H. A. · Sarathy · R. · Rabideau · D. J. · Feldman · J. · Cartagena · L. · Patel · H. · Sequist · L. V. · Park · E. · Jackson · V. · Greer · J. A. · Temel · J. S. · Petrillo · L. A.
Introduction

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.

Methods and analysis

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.

Ethics and dissemination

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.

Trial registration number

NCT04900935.

Reflections on Death and Dying: The Artistry of Nursing at Life's End

Journal of Advanced Nursing, Volume 81, Issue 8, Page 4357-4359, August 2025.

Developing and studying an outcome-focused measure of mental healthcare quality based on patient-reported symptoms in the USA: a study protocol

Por: Young · A. S. · Cai · L. · Jackson · N. J. · Leung · L. B. · Thames · A. D.
Introduction

Various psychological, cognitive, behavioural, medication and neurostimulation treatments can improve the outcomes of people with depressive and anxiety disorders. However, in usual practice, there is large variability in treatment delivery and treatments are poorly characterised. The effectiveness and quality of mental health services in the community are not accurately monitored and are poorly understood. At present, healthcare organisations, payers and policy makers know little about the quality of care they support. Similarly, patients and families have limited information on quality to guide choice of provider or organisation. It will be necessary to implement monitoring of treatment quality so that treatment and outcomes can be improved. This study develops, tests and validates a new, transdiagnostic outcome-focused mental health quality measure. This measure is based on routine, regular patient reports of their symptoms. It is designed to be aggregated at the provider, clinic, organisation or plan level; inform choice of provider; and be used to improve routine delivery of services and quality of care among patients with common psychiatric disorders.

Methods and analysis

The project analyses existing data with responses to a wide variety of items that are known to assess depression or anxiety and empirically selects symptom items for a transdiagnostic outcome-focused quality measure. The project informs risk adjustment and benchmarking of the quality measure by studying how patient, provider and practice factors, including health-related social needs, baseline symptom severity and diagnoses, affect outcomes. Drawing on these, the project specifies an outcome-focused quality measure that includes risk adjustment and benchmarks for improvement; and studies, at practices nationally, its feasibility and psychometric properties, the effect of treatment characteristics on the quality of care, and the effect of quality on health-related quality of life.

Ethics and dissemination

Results will be published. The quality measure is designed to be broadly relevant across community settings and populations and to be submitted for endorsement by regulatory and governing bodies.

Cost-consequence analysis of an e-health intervention to reduce distress in dementia carers: results from the iSupport randomised controlled trial

Por: Anthony · B. · Doungsong · K. · MacLeod · C. · Flynn · G. · Masterson-Algar · P. · Goulden · N. · Egan · K. · Jackson · K. · Kurana · S. · Hughes · G. · Innes · R. · Connaghan · J. · Proctor · D. · Ismail · F. A. · Hoare · Z. · Spector · A. · Stott · J. · Windle · G. · Edwards · R. T.
Objective

The use of e-health interventions has grown in demand due to their accessibility, low implementation costs and their potential to improve the health and well-being of people across a large geographical area. Despite these potential benefits, little is known about the cost-effectiveness of self-guided e-health interventions. The aim of the study was to compare the cost and consequences of ‘iSupport’, an e-health intervention to reduce mental health issues in dementia carers.

Design

A cost-consequence analysis (CCA) of a multi-centre, single-blind randomised controlled trial of iSupport. The CCA was conducted from a public sector (National Health Service, social care and local authority) perspective plus a wider societal perspective. Delivery costs of iSupport were collected using a bottom-up micro-costing approach.

Setting

352 participants were recruited from three centres in England, Wales and Scotland.

Participants

Participants eligible for inclusion were adults over the age of 18 years who self-identified as an unpaid carer with at least 6 months of experience caring for an individual with a diagnosis of dementia. Between 12 November 2021 and 31 March 2023, 2332 carers were invited to take part in the study. 352 participants were randomised: 175 randomised to the iSupport intervention group and 177 to the usual care control group. The mean age of participants in the intervention and control groups was 63 and 62, respectively.

Main outcome measures

The CCA presented the disaggregated costs and health-related quality of life measured using the EuroQol five-dimension.

Results

There was no significant difference in generic health-related quality of life measured using the EQ-5D-5L (p=0.67). Both groups reported higher mean costs between baseline and 6 months, but the change in costs was significantly lower in the intervention group. Between baseline and 6 months, the mean change in total resource use costs from the public sector perspective was significantly different between groups (p=0.003, r=–0.161) reporting a mean change per participant of £146 (95% CI: –33 to 342) between the intervention and control groups. From the wider societal perspective, there was no significant difference (p=0.23) in the mean change in total resource use and informal care costs between the two groups from baseline to 6 months.

Conclusion

Use of iSupport was associated with reduced health and social care resource use costs for carers compared with care-as-usual. Self-guided e-health interventions for dementia carers may have the potential to reduce health and social care resource use and wider societal costs, but evidence relating to their effectiveness and cost-effectiveness is lacking.

Trial registration number

ISRCTN17420703.

European Registry of Hereditary Pancreatic Diseases (EUROPAC): protocol for primary and secondary screening in individuals with inherited pancreatic disease syndromes for pancreatic ductal adenocarcinoma and complications of other pancreatic diseases

Por: Boughey · A. · Hopley · P. · Sarantitis · I. · Thomas · P. · Gubacsi · B. · Jevons · K. · Crowe · E. · Hughes · E. · Quinn · I. · Royle · L. · Jackson · R. J. · Greenhalf · W. · Halloran · C.
Introduction

Pancreatic cancer is a devastating disease and one of the top causes of cancer death worldwide. Over 30% of cases are potentially avoidable, and while screening for this disease should be possible, the current methods, without risk stratification to detect high-risk groups, are unlikely to detect these individuals. A tailored screening pathway could be applied to individuals with a germline genetic cause of pancreatic cancer, which may account for around 10% of cases.

Methods and analysis

EUROPAC, although having international reach, is described here in relation to the UK only. This national prospective observational study has run for several decades but was modified into the current trial in 2019, which aims to recruit and screen 10 000 individuals with either familial pancreatic cancer or hereditary pancreatitis (HP). Applicants are assessed for eligibility by generating an individual pedigree and by attributing a family risk score (FR). Individual risk is assessed according to age. Individuals over 40 with an FR >30 are offered baseline imaging and then three yearly triplets of annual endoscopic ultrasound (EUS) and an MRI (in the third year). Those with an FR >60 are offered both EUS and MRI yearly. HP patients are screened by CT and/or MRI dependent on risk stratification using the presence of diabetes, smoking or alcohol consumption. Low-risk (absence of these factors) patients have a CT every 2 years, and high-risk (one or more of the above factors) patients have alternate yearly screening with CT, then MRI. Biospecimens are collected at pragmatic intervals with first sampling at registration to support future biomarker development to detect pancreatic cancer early. Detection of early-stage pancreatic cancer and actionable lesions will be evaluated.

Ethics and dissemination

The EUROPAC study has been reviewed and approved by the Yorkshire and Humber Research Ethics Committee (Ref 19/YH/0250). Study results will be disseminated through national and international symposium presentations and published in peer-reviewed, open-access journals. All participants provided informed consent prior to entering the study.

Trial registration number

ISRCTN62546421

Determining the frequency of pressure ulcers incidence and associated risk factors in critical care patients: A 3‐year retrospective study

Abstract

One of the key measures to prevent pressure ulcer is to identify the factors that influence them. This study aimed to assess the occurrence of pressure ulcers and their related risk factors in patients admitted to specialized care units. This research is a retrospective cohort study that was conducted in the critical care units of hospitals affiliated to Ardabil University of Medical Sciences. A total of 1158 patient records who were hospitalized in the intensive care unit (ICU) between 2021 and 2022 were selected from the research population using the available sampling method and based on the inclusion criteria. Data was collected using a researcher-made checklist between April 2021 and December 2022. Data were analysed using analytical tests (chi-squared test, regression test) and descriptive statistics (prevalence, mean, standard deviation, and median) tests. All 1158 patient files were examined without any sample loss. The average age of the patients was 58.59 ± 19.73 years. The study found a significant association between the occurrence of pressure ulcers and age, duration of hospitalization, weight, body temperature, and male gender (p-value <0.001). Additionally, there was a significant association between the occurrence of pressure ulcers and the use of pain relievers, vasopressors, alpha-blockers, calcium blockers, and angiotensin (p-value 0.001). The study also investigated the association between nursing care practices and the development of pressure ulcers. The findings revealed that changing the angle of the bed, using a wavy mattress, repositioning the patient every 2 h, using a CPR bed for mobility, providing protective equipment, and applying physical restraint to the patient were all significantly associated with the likelihood of pressure ulcers (p < 0.001). The study showed that pressure ulcers in ICU patients are influenced by the type of disease and clinical factors in individuals. However, considering the conflicting results of this study with some other studies, more research is needed on this subject. It is suggested that appropriate measures be taken based on the patient's condition to prevent pressure ulcers in those admitted to the ICU.

Early identification of pressure injuries in people with dark skin tones: Qualitative perspectives from community‐based patients and their carers

Abstract

Aim

To examine the personal experiences and perceptions of people with dark skin tones and their carers, in relation to pressure injury.

Design

Qualitative study using semi-structured interviews.

Methods

Twenty-two interviews with people with dark skin tone and/or their family carers, who were known to and visited by community nurses for pressure area management or who had been identified as being at high risk for developing a pressure injury were carried out.

Results

Thematic analysis of the interview transcripts revealed that skin discolouration towards a darker hue than usual was the commonest symptom identified by participants as a sign of altered skin integrity and potential pressure damage. Four main overarching themes were revealed through comprehensive analysis of the transcripts: (1) indicators of pressure injury; (2) experienced symptoms of pressure damage; (3) trust in healthcare workers; and (4) improving care for populations with dark skin tones.

Conclusion

The findings from this study clearly present how early-stage pressure damage is identified among people with dark skin tones.

Implications for the Profession and/or Patient Care

These findings have the potential to reduce health inequality by influencing and informing clinical policies and strategies in practice. Findings could also lead to the development of patient-informed educational strategies for nurses and health workers which will enable the early identification of pressure ulcers among people with dark skin tones. Further research is needed to better understand health disparities in relation to preventable patient safety harm.

Impact

The findings demonstrate the importance of engaging with and listening to the stories and experiences of people living with pressure damage to help in the early recognition of pressure injuries.

Reporting Method

The Consolidated Criteria for Reporting Qualitative Research (COREQ) guidelines for qualitative research were followed.

Patient or Public Contribution

A project steering group reviewed information sheets for participants and checked the interview questions were relevant and suitable.

Is elderspeak communication in simulated hospital dementia care congruent to communication in actual patient care? A mixed‐methods pilot study

Abstract

Aims

Simulation offers a feasible modality to prepare nurses for challenges communicating with patients with dementia. Elderspeak communication is speech that sounds like baby talk and can lead to rejection of care by patients with dementia. However, it is unknown if simulation can be used to capture elderspeak communication in dementia care. The purpose of this mixed-methods study was to determine if simulation accurately captures elderspeak communication by nursing staff in hospital dementia care.

Design

A 3-part mixed-methods design in which (1) three dementia care simulations were designed and validated by a panel of experts, (2) communication by nursing staff completing each simulation was quantitatively compared to communication during actual patient care, and (3) views on the realism were explored using within- and across-case coding.

Methods

Three simulations using different modalities (manikin, role-play, and standardised patient) were designed and validated with eight experts using the Lynn Method. Ten nursing staff were audio-recorded and their communication was coded for elderspeak communication. Results for each simulation were compared using Wilcoxon signed-rank test to recordings taken during actual dementia care encounters. Debriefings were coded for realism and results were converged.

Results

The average time using elderspeak during naturalistic care was 29.9% (SD = 20.9%) which did not differ from the average amount of elderspeak used across the three simulations modalities which ranged from 29.1% to 30.4%. Qualitative results suggested a lack of realism with the manikin condition and the nursing staff indicated preference for the simulation with the standardised patient.

Conclusions

Communication elicited in the dementia care simulations was congruent to communication produced in actual dementia care but preference was for the standardised patient.

Implications for Patient Care

Elderspeak communication can be accurately produced in the simulated environment which indicates that simulation is a valid method for person-centred communication training in nursing staff.

Impact

Simulation offers a feasible modality to prepare nurses for challenges communicating with patients with dementia. Elderspeak communication is speech that sounds like baby talk and can lead to rejection of care by patients with dementia. However, it is unknown if simulation can be used to capture elderspeak communication in dementia care. Elderspeak communication captured in the simulated environment was congruent to communication nursing staff use during actual patient care to hospitalised persons living with dementia. This study empirically identifies that communication is elicited in similar patterns by nursing staff in the simulated environment compared to the naturalistic care environment which demonstrates that simulation can be used as a valid tool for education and research on person-centred communication.

Reporting Methods

STROBE.

Patient or Public Contribution

No Patient or Public Contribution.

Beyond order‐based nursing workload: A retrospective cohort study in intensive care units

Abstract

Introduction

In order to be positioned to address the increasing strain of burnout and worsening nurse shortage, a better understanding of factors that contribute to nursing workload is required. This study aims to examine the difference between order-based and clinically perceived nursing workloads and to quantify factors that contribute to a higher clinically perceived workload.

Design

A retrospective cohort study was used on an observational dataset.

Methods

We combined patient flow, nurse staffing and assignment, and workload intensity data and used multivariate linear regression to analyze how various shift, patient, and nurse-level factors, beyond order-based workload, affect nurses' clinically perceived workload.

Results

Among 53% of our samples, the clinically perceived workload is higher than the order-based workload. Factors associated with a higher clinically perceived workload include weekend or night shifts, shifts with a higher census, patients within the first 24 h of admission, and male patients.

Conclusions

The order-based workload measures tended to underestimate nurses' clinically perceived workload. We identified and quantified factors that contribute to a higher clinically perceived workload, discussed the potential mechanisms as to how these factors affect the clinically perceived workload, and proposed targeted interventions to better manage nursing workload.

Clinical Relevance

By identifying factors associated with a high clinically perceived workload, the nurse manager can provide appropriate interventions to lighten nursing workload, which may further reduce the risk of nurse burnout and shortage.

Best practices for communication while wearing facemasks: A scoping review

Abstract

Introduction

Facemasks are an important piece of personal protective equipment (PPE) to mitigate the spread of respiratory illnesses, but they can impede communication between patients and healthcare providers. The purpose of this scoping review is to identify effective communication practices while wearing facemasks.

Design

Scoping review using a systematic search of articles from the PubMed, CINAHL, and Embase databases.

Methods

The PEO (population, exposure, outcome) methodology was selected for this systematic scoping review. The population of interest (P) includes humans of all ages (children, adults, and older adults); the exposure of interest (E) is PPE that covers the mouth (i.e., facemasks); and the outcome of interest (O) is successful or unsuccessful communication practices. The Johns Hopkins Evidence-Based Practice for Nurses and Healthcare Professionals appraisal guidelines were used to determine the level and quality of the research.

Results

Thirty-nine articles met the inclusion criteria. Seventeen of these were high- or good-quality research studies, and the remaining 22 were non-research articles included with separate analysis as part of the scoping review. The 17 articles encompassed 2656 participants. The highest quality evidence indicated that standard surgical masks have the least impact on speech perception compared to other non-transparent mask types, and that recognizing emotions is less accurate with facemasks, necessitating compensatory actions (i.e., reducing extraneous noise, using a microphone to amplify voice, and employing clear speech). Evidence was contradictory regarding the use of transparent masks. Evidence was of limited quality for other non-verbal and verbal communication strategies.

Conclusion

Awareness of communication challenges is crucial when wearing facemasks. More high-quality studies are needed to evaluate communication techniques when speakers are wearing facemasks. Basic strategies such as selecting an appropriate mask type, reducing extraneous noise, using microphones, verbalizing emotions, and employing clear speech appear to be beneficial.

Clinical Relevance

The findings of this scoping review highlight the importance of considering communication challenges while wearing facemasks in the healthcare settings. The review suggests that selecting an appropriate mask type, reducing extraneous noise, verbalizing emotions, and employing clear speech are some strategies that may be effective in mitigating the impact of facemasks on communication between patients and healthcare providers.

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