Supporting dementia carers is a global priority. As a Randomised Controlled Trial (RCT) (n = 352) of the Word Health Organization recommended, an internationally disseminated ‘iSupport’ e-health intervention was conducted, revealing no measurable benefits to the wellbeing of adult dementia carers. This process evaluation contributes original insights of the trial outcomes. Its aims were to ascertain the usability and acceptability of iSupport, participant engagement and adherence to iSupport, and contextual factors influencing its implementation and potential impact. The process evaluation followed a mixed-method design. The following data were collected from all participants randomised to iSupport (n = 175): (1) post-intervention evaluation questionnaire (n = 93) containing the 10-item System Usability Scale and bespoke items exploring acceptability, engagement, and perceived impact; (2) qualitative interviews (n = 52) with a sub-sample of participants who were purposively sampled according to age, scores on the outcome measures, and gender, as these interviews aimed to generate contextual detail and explanatory accounts; and (3) ‘Access’ data from the iSupport platform (n = 175). Descriptive statistics was used to report on the frequency of survey responses whilst a thematic analysis approach was followed to identify themes from the qualitative interview data. Data sets were analysed independently and then used with respect to one another in order to generate explanatory pathways related to the usability, acceptability, and the impact of iSupport. Despite good trial retention, 8.3% of participants (n = 32) did not spend any time on iSupport, and 54% (n = 94) spent between 30 min and 1.5 h. Factors driving this were the following: time constrains, method of delivery, and content characteristics. Positive impacts of iSupport were also described. Participants, including those with extensive caring experience, reported how iSupport had made them feel reassured, valued, and more able to ask for help. They also reported having an improved outlook on their caring role and on the needs and feelings of the person living with dementia. Research and practice should focus on exploring blended delivery, including self-directed and interactive components, such as regular contact with a health professional. These insights are critical for supporting the global implementation and adaptation of iSupport and offer valuable directions for future research.

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. 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. 352 participants were recruited from three centres in England, Wales and Scotland. 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. The CCA presented the disaggregated costs and health-related quality of life measured using the EuroQol five-dimension. 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. 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. ISRCTN17420703.

Background:Sustaining the capabilities of dementia carers is a global priority. 'iSupport' is a self-guided online intervention designed by the World Health Organization (WHO) to reduce mental health problems in dementia carers. iSupport is undergoing global implementation, however there is an absence of effectiveness evidence. This study tested the effectiveness of iSupport to reduce distress and depression in dementia carers. Methods:A pragmatic randomised controlled trial was conducted in three centres. Adult carers (18+) living in the community were recruited in England, Wales and Scotland and randomly assigned (1:1) through a web-based system to iSupport or usual care. Outcome assessors were masked to allocation. The primary outcomes assessed the difference in distress and depression between baseline and six-months. The target sample size was 350 to enable 90% power, significance at 2.5% including 25% attrition (262 completers) on either outcome. Analysis followed the intention-to-treat (ITT) principle. The trial was registered with ISRCTN registry (17420703). Findings:Between 12th November 2021 and 31st March 2023,177 carers (50.3%) were randomised to usual care and 175 (49.7%) to iSupport. 263 (74.7%) completed the trial. All were included in the ITT analysis. Mean distress scores at six-months were 20.0 (SD = 8.3) for usual care and 20.6 (SD = 8.6) for iSupport. The mean difference was 0.16 (95% CI -1.17 to 1.49, p = 0.29) after adjusting for covariates. Mean depression scores at six-months were 9.5 (SD = 7.0) for usual care and 9.8 (SD = 6.5) for iSupport. The mean difference at six-months was -0.54 (95% CI = -1.70 to 0.62, p = 0.44). No serious adverse events were linked to the trial. Interpretation:To our knowledge this is the largest trial evaluating a self-guided online intervention in UK dementia carers, and the first to successfully evaluate the effectiveness of iSupport. The null findings are significant given the ongoing global implementation of iSupport by the WHO and the adoption of self-guided interventions into mainstream care delivery as part of digital health transformations. Funding:NIHR.

Due to population ageing and medical advances, people with advanced chronic diseases (ACD) live longer. Such patients are even more likely to face either temporary or permanent reduced functional reserve, which typically further increases their healthcare resource use and the burden of care on their caregiver(s). Accordingly, these patients and their caregiver(s) may benefit from integrated supportive care provided via digitally supported interventions. This approach may either maintain or improve their quality of life, increase their independence, and optimize the healthcare resource use from early stages. ADLIFE is an EU-funded project, aiming to improve the quality of life of older people with ACD by providing integrated personalized care via a digitally enabled toolbox. Indeed, the ADLIFE toolbox is a digital solution which provides patients, caregivers, and health professionals with digitally enabled, integrated, and personalized care, supporting clinical decisions, and encouraging independence and self-management. Here we present the protocol of the ADLIFE study, which is designed to provide robust scientific evidence on the assessment of the effectiveness, socio-economic, implementation, and technology acceptance aspects of the ADLIFE intervention compared to the current standard of care (SoC) when applied in real-life settings of seven different pilot sites across six countries. A quasi-experimental trial following a multicenter, non-randomized, non-concurrent, unblinded, and controlled design will be implemented. Patients in the intervention group will receive the ADLIFE intervention, while patients in the control group will receive SoC. The assessment of the ADLIFE intervention will be conducted using a mixed-methods approach.

Sexual issues and treatment side effects are not routinely discussed with men receiving treatment for prostate cancer, and support to address these concerns is not consistent across settings. This study evaluates a brief e-learning resource designed to improve sexual wellbeing support and examine its effects on healthcare professionals’ sexual attitudes and beliefs. Healthcare professionals (n = 44) completed an online questionnaire at baseline which included a modified 12-item sexual attitudes and beliefs survey (SABS). Follow-up questionnaires were completed immediately after the e-learning and at 4 weeks. Data were analysed using one-way, repeat measures ANOVAs to assess change in attitudes and beliefs over time. Significant improvements were observed at follow-up for a number of survey statements including ‘knowledge and understanding’, ‘confidence in discussing sexual wellbeing’ and the extent to which participants felt ‘equipped with the language to initiate conversations’. The resource was seen as concise, relevant to practice and as providing useful information on potential side effects of treatment. In brief, e-learning has potential to address barriers to sexual wellbeing communication and promote delivery of support for prostate cancer survivors. Practical methods and resources should be included with these interventions to support implementation of learning and long-term changes in clinical behaviour.

Background Sexual dysfunction is a frequent side effect associated with different prostate cancer treatment approaches. It can have a substantial impact on men and their partners and is associated with increased psychological morbidity. Despite this, sexual concerns are often not adequately addressed in routine practice. Evidence-based web-based interventions have the potential to provide ongoing information and sexual well-being support throughout all stages of care. Objective The aim of this study is to examine the efficacy of a web-based self-management intervention designed to maximize sexual well-being in men living with prostate cancer and explore user perspectives on usability and acceptability. Methods We used a single-arm study design, and participants were provided with access to the 5-step intervention for a period of 3 months. The intervention content was tailored based on responses to brief screening questions on treatment type, relationship status, and sexual orientation. Efficacy was assessed by using two-tailed, paired sample t tests for comparing the mean differences between pre- and postintervention measurements for exploring the participants’ self-reported knowledge and understanding, sexual satisfaction, and comfort in discussing sexual issues. Usability and acceptability were determined based on the program use data and a postintervention survey for exploring perceived usefulness. Results A total of 109 participants were recruited for this study. Significant postintervention improvements at follow-up were observed in the total scores (out of 20) from the survey (mean 12.23/20 points, SD 2.46 vs mean 13.62/20, SD 2.31; t88=9.570; P=.001) as well as in individual item scores on the extent to which the participants agreed that they had sufficient information to manage the impact that prostate cancer had on their sex life (mean 2.31/4 points, SD 0.86 vs mean 2.57/4, SD 0.85; t88=3.660; P=.001) and had the potential to have a satisfying sex life following treatment (mean 2.38/4 points, SD 0.79 vs mean 3.17/4, SD 0.78; t88=7.643; P=.001). The median number of intervention sessions was 3 (range 1-11), and intervention sessions had a median duration of 22 minutes (range 8-77). Acceptable usability scores were reported, with the highest result observed for the question on the extent to which the intervention provided relevant information. Conclusions This study provides evidence on the efficacy of a tailored web-based intervention for maximizing sexual well-being in men living with prostate cancer. The results indicate that the intervention may improve one’s self-perceived knowledge and understanding of how to manage sexual issues and increase self-efficacy or the belief that a satisfactory sex life could be achieved following treatment. The findings will be used to refine the intervention content before testing as part of a larger longitudinal study for examining its effectiveness.

Objective: To systematically develop a framework to improve sexual wellbeing communication in routine prostate cancer care. Methods: The Theoretical Domains Framework was used to guide a multi-phase process used to identify components of the framework based on evidence reviews, semi-structured interviews and stakeholder workshops. 'Think-aloud' testing was used to explore usability, potential barriers and other factors relevant to implementation. Results: A conceptual communication framework consisting of 'Engagement' (E), 'Assessment' (A), information and 'Support' (S) and 'Sign-posting' (Si) sections was developed. The framework emphasises routine engagement to normalise sexual concerns, brief, non-sensitive assessment, personalised advice based on treatment type and relationship status, and a mechanism for referral to additional support or self-management resources in the form of a patient and partner handout. Usability testing identified strategies to promote implementation. Conclusions: The proposed framework is appropriate for use in routine practice and appears to be acceptable to patients, partners and healthcare professionals. Its use may help address gaps in sexual wellbeing support for men and partners living with prostate cancer. Further work will be conducted evaluating an online engagement tool, modelled on the framework. Practice Implications: The EASSi framework can facilitate and structure sexual wellbeing conversations and ensure fundamental but individualised support is provided routinely in prostate cancer care. (c) 2020 Elsevier B.V. All rights reserved.

BACKGROUND Long-term side-effects associated with different prostate cancer treatment approaches are common. Sexual challenges are the most frequently occurring issues and can result in increased psychological morbidity. It is recognized that barriers to communication can make initiating discussions around sexual concerns in routine practice difficult. Health care professionals need to routinely initiate conversations, effectively engage with patients, and assess needs in order to provide essential support. One proposed method that could support health care professionals to do this involves the use of prompts or structured frameworks to guide conversations. OBJECTIVE This study aimed to assess feasibility, acceptability, and satisfaction with the tablet-based Engagement, Assessment, Support, and Sign-posting (EASSi) tool designed to facilitate and structure sexual well-being discussions in routine prostate cancer care. METHODS Health care professionals (n=8) used the EASSi tool during 89 posttreatment appointments. Quantitative data were recorded based on program usage and surveys completed by health care professionals and patients. Qualitative data exploring perceptions on use of the tool were gathered using semistructured interviews with all health care professionals (n=8) and a sample of patients (n=10). RESULTS Surveys were completed by health care professionals immediately following each appointment (n=89, 100%). Postal surveys were returned by 59 patients (66%). Health care professionals and patients reported that the tool helped facilitate discussions (81/89, 91% and 50/59, 85%, respectively) and that information provided was relevant (82/89, 92% and 50/59, 85%, respectively). The mean conversation duration was 6.01 minutes (SD 2.91). Qualitative synthesis identified the tool’s ability to initiate and structure discussions, improve the “depth” of conversations, and normalize sexual concerns. CONCLUSIONS The EASSi tool was appropriate and acceptable for use in practice and provided a flexible approach to facilitate routine brief conversations and deliver essential sexual well-being support. Further work will be conducted to evaluate the effectiveness of using the tablet-based tool in prostate cancer care settings.

BACKGROUND Patients with malignant pleural mesothelioma (MPM) have a life-limiting illness and short prognosis and experience many debilitating symptoms from early in the illness. Innovations such as remote symptom monitoring are needed to enable patients to maintain wellbeing and manage symptoms in a proactive and timely manner. The Advanced Symptom Management System (ASyMS) has been successfully used to monitor symptoms associated with cancer. OBJECTIVE This study aimed to determine the feasibility and acceptability of using an ASyMS adapted for use by patients with MPM, called ASyMSmeso, enabling the remote monitoring of symptoms using a smartphone. METHODS This was a convergent mixed methods study using patient-reported outcome measures (PROMs) at key time points over a period of 2-3 months with 18 patients. The Sheffield Profile for Assessment and Referral for Care (SPARC), Technology Acceptance Model (TAM) measure for eHealth, and Lung Cancer Symptom Scale-Mesothelioma (LCSS-Meso) were the PROMs used in the study. Patients were also asked to complete a daily symptom questionnaire on a smartphone throughout the study. At the end of the study, semistructured interviews with 11 health professionals, 8 patients, and 3 carers were conducted to collect their experience with using ASyMSmeso. RESULTS Eighteen patients with MPM agreed to participate in the study (33.3% response rate). The completion rates of study PROMs were high (97.2%-100%), and completion rates of the daily symptom questionnaire were also high, at 88.5%. There were no significant changes in quality of life, as measured by LCSS-Meso. There were statistically significant improvements in the SPARC psychological need domain (P=.049) and in the “Usefulness” domain of the TAM (P=.022). End-of-study interviews identified that both patients and clinicians found the system quick and easy to use. For patients, in particular, the system provided reassurance about symptom experience and the feeling of being listened to. The clinicians largely viewed the system as feasible and acceptable, and areas that were mentioned included the early management of symptoms and connectivity between patients and clinicians, leading to enhanced communication. CONCLUSIONS This study demonstrates that remote monitoring and management of symptoms of people with MPM using a mobile phone are feasible and acceptable. The evidence supports future trials using remote symptom monitoring to support patients with MPM at home.

Objective: To design and develop a digital monitoring application to support and improve the care of patients in the first 30 post-operative days following colorectal cancer surgery. Data Sources: Patient interviews, health professional focus groups, patient co-creation activities, and health professional prioritization discussions. Conclusion: The structured and iterative co-design activities adopted in this study with key stakeholders, including patients and health professionals, lead to the development of a prototype application (app) to support patients at home during the first 30 days following surgery for colorectal cancer. A similar approach could be implemented to develop comparable apps for patients with other cancer diagnoses requiring different surgical procedures. Further research should focus on the continued development and testing of this app in relation to patient care and outcomes as well as the app's affect on nursing and other health services. Implications for Nursing Practice: Clinical implementation of remote monitoring following discharge home after surgery for colorectal cancer gives patients the opportunity to report issues of concern to relevant health professionals. This could facilitate the early identification of concerning signs and symptoms, ensuring appropriate and timely interventions to minimize readmission rates. Patients' experiences during the recovery period could also be improved through the provision of reliable and relevant online information. More specifically, health professionals could easily identify those patients requiring additional support to manage their recovery, for example, those with more severe symptoms or problems, facilitating the direction of appropriate health services to those most in need of their expertise. (C) 2020 Published by Elsevier Inc.

Prostate cancer is the most common cancer among men. Many patients experience significant, long-term side effects of treatment, including sexual dysfunction. These effects, in particular, erectile dysfunction and low desire, can lead to anxiety, relational dis-satisfaction and low self-esteem which can have a substantial impact on overall quality of life1. Currently, services provided globally to address sexual health concerns are variable and highly fragmented; and many men report not receiving adequate care. Men are often left in the dark about the possible psychosexual consequences of treatment and do not know how, and where, to seek information and support to self-manage their condition. Although initiating conversations and providing support around sexual health is an important component of care; health professionals report often feeling unequipped to deal with these issues, and say they lack appropriate resources to offer men and partners2. To systematically develop and provide an initial evaluation of clinical and training interventions designed to enable providers, including those without formal training in sexual health, to support patients and partners; and address sexual health needs after prostate cancer diagnosis. The overall purpose of the study is to develop services which ensure all men will have access to a minimal level of psychosexual support, following diagnosis of prostate cancer.

Objectives: To explore healthcare professional perceived barriers and facilitators to discussing sexual health and wellbeing with patients after diagnosis of chronic illness. Methods: Five databases were searched and included data were synthesised using a meta-ethnographic approach. Confidence in findings was assessed using the GRADE-CERQual framework. Searches, extraction and quality assessment procedures were conducted independently by at least two authors. Results: Concepts extracted from 30 included studies were used to develop a conceptual framework based on five overarching themes. These were [1] individual and societal attitudes to sex and sexual wellbeing [2], patient specific factors [3], organizational and professional factors [4], strategies to overcome barriers in practice and [5] perceived training needs. Healthcare professionals acknowledged the importance of discussing and providing support for sexual wellbeing needs, but recognized it is not routinely provided. Conclusions: While patient specific factors and organizational issues such as lack of time were frequently identified as barriers, intra-personal and social perceptions appear to have the strongest influence on healthcare professional perspectives. Practice implications: Brief education and tools to support healthcare professionals to have effective conversations with patients are required. These should address social barriers, normalise sexual issues, and support healthcare professionals to initiate discussions around sexual concerns. (C) 2018 Published by Elsevier B.V.

Close monitoring of chemotherapy toxicity can be instrumental in ensuring prompt symptom management and quality care. Our aim was to develop a brief clinical tool to enable daily assessment of chemotherapy toxicity and investigate/establish its content validity, feasibility/applicability, internal consistency and stability. Development of the Daily Chemotherapy Toxicity self-Assessment Questionnaire (DCTAQ) was based on an initial item pool created from two scoping reviews. Expert panel review (n = 15) and cognitive debriefing with patients with cancer (n = 7) were used to establish content validity. Feasibility/acceptability, applicability (self-report vs. interview-like administration), internal consistency (KR-20) and test-retest reliability (at 1-hr intervals) of the DCTAQ were field-tested with 82 patients with breast or colorectal cancer receiving active chemotherapy at eight hospitals. Initial development/content validity stages enabled item revisions and re-wording that led to a final, 11-item DCTAQ version with 10 core symptom items plus one open-ended "any other symptom" item. Feasibility and acceptability were demonstrated through the absence of participant withdrawals, absence of missing data and no complaints about tool length. The DCTAQ was found to have modest internal consistency (KR-20 = 0.56), but very good test-retest reliability. The DCTAQ is a brief clinical tool that allows for rapid and accurate daily assessments of chemotherapy toxicity in clinical practice.

PURPOSE:Living with a melanoma diagnosis can be challenging. We aimed to assess the feasibility, acceptability, and perceived value of a nurse-led intervention that utilised patient-reported outcome (PRO) measures to identify and address the supportive care needs of newly diagnosed patients with Stage I/II melanoma over the first 4 months post-diagnosis. METHODS:We conducted an exploratory, repeated-measures, single-arm, feasibility trial. One baseline (4 weeks post-diagnosis; T1) and one follow-up intervention session (4 weeks after wide local excision; T3) took place, two months apart. Patient survey data were collected monthly, at four assessment points (T1-T4), followed by exit interviews. RESULTS:A recruitment rate of 55% (10/18) was achieved. The skin cancer nurse specialist (CNS) performed 19 in-clinic patient assessments within 6 months. One patient missed their follow-up intervention session (90% retention rate). Three participants (30%) were lost to follow-up at T4. Patients endorsed the standardised use of easy-to-use PRO measures as a means to help them shortlist, report and prioritise their needs. The CNS viewed the intervention as a highly structured activity that allowed tailoring support priority needs. A sizeable reduction in information needs was found from T1 to T4 (Standardised Response Mean [SRM] change = -0.99; p < 0.05). From T1 to T2, significant reductions in psychological (SRM change = -1.18; p < 0.001), practical (SRM change = -0.67; p < 0.05) and sexuality needs (SRM change = -0.78; p < 0.05) were observed. CONCLUSIONS:The intervention appears to be feasible in clinical practice and acceptable to both patients with newly diagnosed melanoma and clinicians. Future research is warranted to test its effectiveness against standard care.

Background: The use of technology-enhanced patient-reported outcome measures to monitor the symptoms experienced by people with cancer is an effective way to offer timely care. Objective: This study aimed to (a) explore the feasibility and acceptability of the Advanced Symptom Management System with patients with lung cancer receiving radiotherapy and clinicians involved in their care and (b) assess changes in patient outcomes during implementation of the Advanced Symptom Management System with patients with lung cancer receiving radiotherapy in clinical practice. Methods: A repeated-measures, single-arm, mixed-methods study design was used involving poststudy interviews and completion of patient-reported outcome measures at baseline and end of treatment with 16 patients with lung cancer and 13 clinicians who used this mobile phone-based symptom monitoring system. Results: Only rarely did patients report problems in using the handset and they felt that the system covered all relevant symptoms and helped them to manage their symptoms and effectively communicate with clinicians. Clinical improvements in patient anxiety, drowsiness, and self-care self-efficacy were also observed. Clinicians perceived the use of "real-time" risk algorithms and automated self-care advice provided to patients as positively contributing to clinical care. Reducing the complexity of the system was seen as important to promote its utility. Conclusions: Although preliminary, these results suggest that monitoring patient symptoms using mobile technology in the context of radiotherapy for lung cancer is feasible and acceptable in clinical practice. Implications for practice: Future research would be most beneficial if the use of this technology was focused on the postradiotherapy phase and expanded the scope of the system to encompass a wider range of supportive care needs.

Background: The use of technology-enhanced patient-reported outcome measures to monitor the symptoms experienced by people with cancer is an effective way to offer timely care. Objective: This study aimed to (a) explore the feasibility and acceptability of the Advanced Symptom Management System with patients with lung cancer receiving radiotherapy and clinicians involved in their care and (b) assess changes in patient outcomes during implementation of the Advanced Symptom Management System with patients with lung cancer receiving radiotherapy in clinical practice. Methods: A repeated-measures, single-arm, mixed-methods study design was used involving poststudy interviews and completion of patient-reported outcome measures at baseline and end of treatment with 16 patients with lung cancer and 13 clinicians who used this mobile phone–based symptom monitoring system. Results: Only rarely did patients report problems in using the handset and they felt that the system covered all relevant symptoms and helped them to manage their symptoms and effectively communicate with clinicians. Clinical improvements in patient anxiety, drowsiness, and self-care self-efficacy were also observed. Clinicians perceived the use of “real-time” risk algorithms and automated self-care advice provided to patients as positively contributing to clinical care. Reducing the complexity of the system was seen as important to promote its utility. Conclusions: Although preliminary, these results suggest that monitoring patient symptoms using mobile technology in the context of radiotherapy for lung cancer is feasible and acceptable in clinical practice. Implications for practice: Future research would be most beneficial if the use of this technology was focused on the postradiotherapy phase and expanded the scope of the system to encompass a wider range of supportive care needs.

This paper describes an ongoing study of the Advanced Symptom Management System (ASyMS) for patients receiving chemotherapy for breast or colorectal cancer. We begin by detailing the ASyMS work to date, providing an overview of research conducted in the field over the last ten years. The current study, ASyMS-III, is then presented, highlighting the study methodology, multi-site involvement, the outcomes being measured, and discussion of the tool. The paper concludes with reflections on the progress of the ASyMS-III study to date, and discusses potential directions for future research.