A randomised controlled trial of a digital intervention (Renewed) to support symptom management, wellbeing and quality of life in cancer survivors.

BACKGROUND: Many cancer survivors following primary treatment have prolonged poor quality of life. AIM: To determine the effectiveness of a bespoke digital intervention to support cancer survivors. DESIGN: Pragmatic parallel open randomised trial. SETTING: UK general practices. METHODS: People having finished primary treatment (<= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score <85, were randomised by online software to: 1)detailed 'generic' digital NHS support ('LiveWell';n=906), 2) a bespoke complex digital intervention ('Renewed';n=903) addressing symptom management, physical activity, diet, weight loss, distress, or 3) 'Renewed-with-support' (n=903): 'Renewed' with additional brief email and telephone support. RESULTS: Mixed linear regression provided estimates of the differences between each intervention group and generic advice: at 6 months (primary time point: n's respectively 806;749;705) all groups improved, with no significant between-group differences for EORTC QLQ-C30, but global health improved more in both intervention groups. By 12 months there were: small improvements in EORTC QLQ-C30 for Renewed-with-support (versus generic advice: 1.42, 95% CIs 0.33-2.51); both groups improved global health (12 months: renewed: 3.06, 1.39-4.74; renewed-with-support: 2.78, 1.08-4.48), dyspnoea, constipation, and enablement, and lower NHS costs (generic advice £265: in comparison respectively £141 (153-128) and £77 (90-65) lower); and for Renewed-with-support improvement in several other symptom subscales. No harms were identified. CONCLUSION: Cancer survivors quality of life improved with detailed generic online support. Robustly developed bespoke digital support provides limited additional short term benefit, but additional longer term improvement in global health enablement and symptom management, with substantially lower NHS costs.

Examining the optimal factors that promote implementation and sustainability of a network intervention to alleviate loneliness in community contexts.

Community environments have the potential to alleviate loneliness and social isolation as they offer opportunity for sociality and to expand personal social network connections. Implementing a social network intervention in community environments to connect people to who are at risk of loneliness or social isolation could help alleviate these concerns. However, implementing interventions in community environments is made difficult by the interplay between the community context and intervention. Thus, to support implementation a detailed understanding of the types of community contexts is required. To examine the optimal factors that promote the implementation of a social network designed to alleviate loneliness and social isolation intervention in the community observations, interviews and documentary analysis were conducted. The Consolidated Framework for Implementation Research and a typology of community contexts were used to inform the data analysis and interpret the findings. Key factors were found to affect the implementation of the intervention in the different community contexts. These inter-related factors operated across three domains. Service User Needs affected intervention take up as its suitability varied. The stability of the workforce and nature of everyday work also impacted on implementation. Finally, the fluctuating capacity of organisations and the organisational culture were also influential. No single community environment was found to have all of the optimal factors required for implementation and sustainably. The UK policy agenda of austerity had negatively affected community environments' capacity to deliver such intervention through increasing service user needs and reducing available resources. Trial registration: ISRCTN19193075.

Implementing a digital intervention for managing uncontrolled hypertension in Primary Care: a mixed methods process evaluation.

BACKGROUND: A high proportion of hypertensive patients remain above the target threshold for blood pressure, increasing the risk of adverse health outcomes. A digital intervention to facilitate healthcare practitioners (hereafter practitioners) to initiate planned medication escalations when patients' home readings were raised was found to be effective in lowering blood pressure over 12 months. This mixed-methods process evaluation aimed to develop a detailed understanding of how the intervention was implemented in Primary Care, possible mechanisms of action and contextual factors influencing implementation. METHODS: One hundred twenty-five practitioners took part in a randomised controlled trial, including GPs, practice nurses, nurse-prescribers, and healthcare assistants. Usage data were collected automatically by the digital intervention and antihypertensive medication changes were recorded from the patients' medical notes. A sub-sample of 27 practitioners took part in semi-structured qualitative process interviews. The qualitative data were analysed using thematic analysis and the quantitative data using descriptive statistics and correlations to explore factors related to adherence. The two sets of findings were integrated using a triangulation protocol. RESULTS: Mean practitioner adherence to escalating medication was moderate (53%), and the qualitative analysis suggested that low trust in home readings and the decision to wait for more evidence influenced implementation for some practitioners. The logic model was partially supported in that self-efficacy was related to adherence to medication escalation, but qualitative findings provided further insight into additional potential mechanisms, including perceived necessity and concerns. Contextual factors influencing implementation included proximity of average readings to the target threshold. Meanwhile, adherence to delivering remote support was mixed, and practitioners described some uncertainty when they received no response from patients. CONCLUSIONS: This mixed-methods process evaluation provided novel insights into practitioners' decision-making around escalating medication using a digital algorithm. Implementation strategies were proposed which could benefit digital interventions in addressing clinical inertia, including facilitating tracking of patients' readings over time to provide stronger evidence for medication escalation, and allowing more flexibility in decision-making whilst discouraging clinical inertia due to borderline readings. Implementation of one-way notification systems could be facilitated by enabling patients to send a brief acknowledgement response. TRIAL REGISTRATION: ( ISRCTN13790648 ). Registered 14 May 2015.

Developing a digital intervention for cancer survivors: an evidence-, theory- and person-based approach.

This paper illustrates a rigorous approach to developing digital interventions using an evidence-, theory- and person-based approach. Intervention planning included a rapid scoping review that identified cancer survivors' needs, including barriers and facilitators to intervention success. Review evidence (N = 49 papers) informed the intervention's Guiding Principles, theory-based behavioural analysis and logic model. The intervention was optimised based on feedback on a prototype intervention through interviews (N = 96) with cancer survivors and focus groups with NHS staff and cancer charity workers (N = 31). Interviews with cancer survivors highlighted barriers to engagement, such as concerns about physical activity worsening fatigue. Focus groups highlighted concerns about support appointment length and how to support distressed participants. Feedback informed intervention modifications, to maximise acceptability, feasibility and likelihood of behaviour change. Our systematic method for understanding user views enabled us to anticipate and address important barriers to engagement. This methodology may be useful to others developing digital interventions.

Study protocol for 'The Project About Loneliness and Social networks (PALS)': a pragmatic, randomised trial comparing a facilitated social network intervention (Genie) with a wait-list control for lonely and socially isolated people.

INTRODUCTION: Loneliness and social isolation have been identified as significant public health concerns, but improving relationships and increasing social participation may improve health outcomes and quality of life. The aim of the Project About Loneliness and Social networks (PALS) study is to assess the effectiveness and cost-effectiveness of a guided social network intervention within a community setting among individuals experiencing loneliness and isolation and to understand implementation of Generating Engagement in Network Involvement (Genie) in the context of different organisations. METHODS AND ANALYSIS: The PALS trial will be a pragmatic, randomised controlled trial comparing participants receiving the Genie intervention to a wait-list control group. Eligible participants will be recruited from organisations working within a community setting: any adult identified as socially isolated or at-risk of loneliness and living in the community will be eligible. Genie will be delivered by trained facilitators recruited from community organisations. The primary outcome will be the difference in the SF-12 Mental Health composite scale score at 6-month follow-up between the intervention and control group using a mixed effects model (accounting for clustering within facilitators and organisation). Secondary outcomes will be loneliness, social isolation, well-being, physical health and engagement with new activities. The economic evaluation will use a cost-utility approach, and adopt a public sector perspective to include health-related resource use and costs incurred by other public services. Exploratory analysis will use a societal perspective, and explore broader measures of benefit (capability well-being). A qualitative process evaluation will explore organisational and environmental arrangements, as well as stakeholder and participant experiences of the study to understand the factors likely to influence future sustainability, implementation and scalability of using a social network intervention within this context. ETHICS AND DISSEMINATION: This study has received NHS ethical approval (REC reference: 18/SC/0245). The findings from PALS will be disseminated widely through peer-reviewed publications, conferences and workshops in collaboration with our community partners. TRIAL REGISTRATION NUMBER: ISRCTN19193075.

'Every day I worry about something': A qualitative exploration of children's experiences of stress and coping.

OBJECTIVES: Most research investigating children's experiences of stress and coping has utilized a quantitative approach. This study aimed to examine children's experiences of stress by conducting interviews with children and their parents. DESIGN: Dyadic child-parent interviews, embedded within a multiphase design. METHODS: Thirty-eight children (22 boys) aged 7-11 years and 38 parents (34 mothers) completed in-depth dyadic interviews about stressful life events, adversity, and coping, analysed using inductive thematic analysis with a phenomenological lens. RESULTS: Four themes emerged: (1) navigating the social minefield; (2) pressure to thrive in the modern world; (3) fear of the unknown; and (4) learning life's lessons. The first suggested that social relationships are a major feature of children's stress experiences; however, social support was also found to be a beneficial coping mechanism. The second theme highlighted multiple sources of pressure on young children (including school, extracurricular activities, pressure from self and others); the impact of such pressure was dependent upon children's coping resources. The third theme emphasized the difficulty of coping with novel stressors, and how awareness can help reduce this fear. The final theme highlighted important lessons that children can learn from stressful experiences and how to cope with stress. CONCLUSIONS: This study addresses the importance of the person and context-dependent nature of stress and coping in order for children to survive and thrive following stressful experiences. These findings contribute to existing knowledge that could be used to develop a toolkit for coping with stress, designed specifically for children, parents, schools, and services. Statement of contribution What is already known on this subject? Stress experienced in childhood can have a significant impact on psychological and physiological outcomes across the life course. It is known that individual differences are vital for understanding the effects of stress on health, for children as well as adults. Qualitative methods enable deeper understanding of children's experiences of stress and coping. What does the study add? Depth and breadth to understanding children's experiences of stressful events. An individual differences focus on the early stress experience that is frequently overlooked. Support for the use of a dyadic interview approach for assessing children's stress experiences.

Renewed: Protocol for a randomised controlled trial of a digital intervention to support quality of life in cancer survivors.

INTRODUCTION: Low quality of life is common in cancer survivors. Increasing physical activity, improving diet, supporting psychological well-being and weight loss can improve quality of life in several cancers and may limit relapse. The aim of the randomised controlled trial outlined in this protocol is to examine whether a digital intervention (Renewed), with or without human support, can improve quality of life in cancer survivors. Renewed provides support for increasing physical activity, managing difficult emotions, eating a healthier diet and weight management. METHODS AND ANALYSIS: A randomised controlled trial is being conducted comparing usual care, access to Renewed or access to Renewed with brief human support. Cancer survivors who have had colorectal, breast or prostate cancer will be identified and invited through general practice searches and mail-outs. Participants are asked to complete baseline measures immediately after screening and will then be randomised to a study group; this is all completed on the Renewed website. The primary outcome is quality of life measured by the European Organization for Research and Treatment of Cancer QLQ-c30. Secondary outcomes include anxiety and depression, fear of cancer recurrence, general well-being, enablement and items relating to costs for a health economics analysis. Process measures include perceptions of human support, intervention usage and satisfaction, and adherence to behavioural changes. Qualitative process evaluations will be conducted with patients and healthcare staff providing support. ETHICS AND DISSEMINATION: The trial has been approved by the NHS Research Ethics Committee (Reference 18/NW/0013). The results of this trial will be published in peer-reviewed journals and through conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN96374224; Pre-results.

Resilience characteristics and prior life stress determine anticipatory response to acute social stress in children aged 7-11 years.

OBJECTIVES: To assess the interplay of prior life stress and characteristics of resilience in determining how children cope with potentially stressful situations, using a two-phase study that triangulates parent-child dyadic interview data with subsequent experience of an acute laboratory stressor in 7-11-year-olds. METHODS: Participants (n = 34) were designated as being in one of four groups based on high/low levels of prior stress experience and high/low resilience ratings assessed during at-home interviews and from questionnaires measuring recent life events, hassles, and trait coping. During a subsequent laboratory stress protocol, salivary cortisol and heart rate were monitored, and a verbal subjective report was provided. RESULTS: Salivary cortisol showed a significant increase in anticipation of the stress test, heart rate increased during the test, and children self-reported the task as stressful. Males displayed higher levels of cortisol than females in the anticipatory period. We observed no increase in salivary cortisol in response to the stress testing phase. Using the stress/resilience categorization, children with a higher level of resilience were differentiated by cortisol level in anticipation of the acute stress experiment based on their level of prior life stress. Highly resilient children with greater experience of prior life stress showed a lower anticipatory cortisol response than highly resilient children with less experience of prior life stress. CONCLUSIONS: This study highlights the relevance of contextual factors, such as prior stress experience and resilience, in physiological response to the anticipation of acute stress and has implications for understanding how children cope with stressful experiences. Statement of contribution What is already known on this subject? An adaptation to the stress testing paradigm, the Bath Experimental Stress Test for Children (BEST-C) was found to reliably induce a salivary cortisol response in young children, suggesting that peer matching the audience was an effective modification to laboratory social stress testing. Recent work focusing on early life adversity has seen the emergence of prior stress experience and resilience as key factors in the examination of acute stress responses. However, much of the research regarding the impact of childhood stress is ambiguous; some research suggests that if children have experienced prior stressful life events this will enact a positive effect on stress responses and lead to resilience, and other research suggested that it will have a compounding negative effect. What does the study add? Findings provide support for the capacity of the BEST-C to induce an anticipation stress response in children. Contextual factors e.g., prior stress experience and resilience are key for understanding stress responses. Resilient children with more experience of stress show lower cortisol than those with less stress experience.