Implementing a Health Care Professional-Supported Digital Intervention for Survivors of Cancer in Primary Care:Qualitative Process Evaluation of the Renewed Intervention

Background: Primary care has an important role in supporting cancer survivors, yet support is limited because of practitioners’ perceived lack of expertise and time. A digital intervention for cancer survivors could provide an efficient way for primary care staff to support cancer survivors without the need to accumulate expertise and skills to help patients make behaviour changes, providing very brief support alongside this could maximise adherence to the digital interventions. Renewed is a digital intervention combining online behaviour change advice with brief healthcare practitioner support from a nurse or healthcare assistant. Knowledge about the views and experiences of primary care staff providing support alongside a digital intervention for cancer survivors is sparse, limiting understanding of the acceptability and feasibility of this type of intervention. Objective: To explore Supporters’ experiences of providing support to cancer survivors using Renewed, to understand potential barriers and facilitators to implementation of Renewed in practice, and investigate strengths and weaknesses of the intervention from the perspective of healthcare professionals.Methods: This was a qualitative process evaluation, nested within a large trial evaluating Renewed. Twenty-eight semi-structured telephone interviews were conducted with nurses and healthcare assistants. Data were analysed using inductive thematic analysis.Results: Four themes were developed during analysis which reflected factors that Supporters identified as hindering or enabling them to provide support alongside Renewed Online (Themes: Renewed Online as an acceptable digital tool with some improvements; confidence to enact the Supporter role; practicalities of delivering support alongside a digital intervention; and managing a patient-led approach). The analysis suggests that Supporters perceived that a digital intervention such as Renewed would be beneficial to support cancer survivors in primary care, and fit within current practices. However, barriers to providing support alongside a digital intervention were also identified, including concerns about how to facilitate rapport building and, in a minority, concerns about employing a non-directive approach, in which the majority of advice and support is provided through a digital intervention, with brief additional support provided by primary care staff. Conclusion: These findings add to the literature about how best to provide support alongside digital interventions, suggesting that whilst most practitioners cope well with a non-directive approach, a minority require more training to feel confident implementing this. This study suggests that barriers to providing formal support to cancer survivors in primary care could be successfully overcome with an approach like Renewed, where a digital intervention provides most of the support and expertise, and healthcare practitioners provide the additional brief human support to maximise engagement. Strategies to maximise the chances of successful implementation for this type of intervention are discussed. <br/

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

Development of the HT&Me intervention to support women with breast cancer to adhere to adjuvant endocrine therapy and improve quality of life.

BACKGROUND: Breast cancer is the most common cancer in women worldwide. Approximately 80% of breast cancers are oestrogen receptor positive (ER+). Patients treated surgically are usually recommended adjuvant endocrine therapy (AET) for 5-10 years. AET significantly reduces recurrence, but up to 50% of women do not take it as prescribed. OBJECTIVE: To co-design and develop an intervention to support AET adherence and improve health-related quality-of-life (QoL) in women with breast cancer. METHODS: Design and development of the HT&Me intervention took a person-based approach and was guided by the Medical Research Council framework for complex interventions, based on evidence and underpinned by theory. Literature reviews, behavioural analysis, and extensive key stakeholder involvement informed 'guiding principles' and the intervention logic model. Using co-design principles, a prototype intervention was developed and refined. RESULTS: The blended tailored HT&Me intervention supports women to self-manage their AET. It comprises initial and follow-up consultations with a trained nurse, supported with an animation video, a web-app and ongoing motivational 'nudge' messages. It addresses perceptual (e.g. doubts about necessity, treatment concerns) and practical (e.g. forgetting) barriers to adherence and provides information, support and behaviour change techniques to improve QoL. Iterative patient feedback maximised feasibility, acceptability, and likelihood of maintaining adherence; health professional feedback maximised likelihood of scalability. CONCLUSIONS: HT&Me has been systematically and rigorously developed to promote AET adherence and improve QoL, and is complemented with a logic model documenting hypothesized mechanisms of action. An ongoing feasibility trial will inform a future randomised control trial of effectiveness and cost-effectiveness

Identifying determinants of adherence to adjuvant endocrine therapy following breast cancer : a systematic review of reviews

Background: In oestrogen- receptor positive breast cancer, daily oral adjuvant endocrine therapy (ET) for at least 5 years significantly reduces risks of recurrence and breast cancer- specific mortality. However, many women are poorly adherent to ET. Development of effective adherence support requires comprehensive understanding of influences on adherence. We undertook an umbrella review to identify determinants of ET adherence.Methods: We searched PubMed, Embase, CINAHL, PsycINFO, Cochrane and PROSPERO (inception to 08/2022) to identify systematic reviews on factors influencing ET adherence. Abstracted determinants were mapped to the World Health Organization's dimensions of adherence. Reviews were quality appraised and overlap assessed.Results: Of 5732 citations screened, 17 reviews were eligible (9 quantitative primary studies; 4 qualitative primary studies; 4 qualitative or quantitative studies) including 215 primary papers. All five WHO dimensions influenced ET non- adherence: The most consistently identified non- adherence determinants were patient- related factors (e.g. lower perceived ET necessity, more treatment concerns, perceptions of ET ‘cons’ vs. ‘pros’). Healthcare system/healthcare professional- related factors (e.g. perceived lower quality health professional interaction/relationship) were also important and, to a somewhat lesser extent, socio- economic factors (e.g. lower levels of social/economic/material support). Evidence was more mixed for medication- related and condition- related factors, but several may be relevant (e.g. experiencing side- effects, cost). Potentially modifiable factors are more influential than non- modifiable/fixed factors (e.g. patient characteristics)

Planning and optimising a digital intervention to protect older adults' cognitive health.

BackgroundBy 2050, worldwide dementia prevalence is expected to triple. Affordable, scalable interventions are required to support protective behaviours such as physical activity, cognitive training and healthy eating. This paper outlines the theory-, evidence- and person-based development of 'Active Brains': a multi-domain digital behaviour change intervention to reduce cognitive decline amongst older adults.MethodsDuring the initial planning phase, scoping reviews, consultation with PPI contributors and expert co-investigators and behavioural analysis collated and recorded evidence that was triangulated to inform provisional 'guiding principles' and an intervention logic model. The following optimisation phase involved qualitative think aloud and semi-structured interviews with 52 older adults with higher and lower cognitive performance scores. Data were analysed thematically and informed changes and additions to guiding principles, the behavioural analysis and the logic model which, in turn, informed changes to intervention content.ResultsScoping reviews and qualitative interviews suggested that the same intervention content may be suitable for individuals with higher and lower cognitive performance. Qualitative findings revealed that maintaining independence and enjoyment motivated engagement in intervention-targeted behaviours, whereas managing ill health was a potential barrier. Social support for engaging in such activities could provide motivation, but was not desirable for all. These findings informed development of intervention content and functionality that appeared highly acceptable amongst a sample of target users.ConclusionsA digitally delivered intervention with minimal support appears acceptable and potentially engaging to older adults with higher and lower levels of cognitive performance. As well as informing our own intervention development, insights obtained through this process may be useful for others working with, and developing interventions for, older adults and/or those with cognitive impairment

Development of the HT&Me intervention to support women with breast cancer to adhere to adjuvant endocrine therapy and improve quality of life

Background. Breast cancer is the most common cancer in women worldwide. Approximately 80% of breast cancers are oestrogen receptor positive (ER+). Patients treated surgically are usually recommended adjuvant endocrine therapy (AET) for 5–10 years. AET significantly reduces recurrence, but up to 50% of women do not take it as prescribed. Objective. To co-design and develop an intervention to support AET adherence and improve health-related quality-of-life (QoL) in women with breast cancer. Methods. Design and development of the HT&Me intervention took a person-based approach and was guided by the Medical Research Council framework for complex interventions, based on evidence and underpinned by theory. Literature reviews, behavioural analysis, and extensive key stakeholder involvement informed ‘guiding principles’ and the intervention logic model. Using co-design principles, a prototype intervention was developed and refined. Results. The blended tailored HT&Me intervention supports women to self-manage their AET. It comprises initial and follow-up consultations with a trained nurse, supported with an animation video, a web-app and ongoing motivational ‘nudge’ messages. It addresses perceptual (e.g. doubts about necessity, treatment concerns) and practical (e.g. forgetting) barriers to adherence and provides information, support and behaviour change techniques to improve QoL. Iterative patient feedback maximised feasibility, acceptability, and likelihood of maintaining adherence; health professional feedback maximised likelihood of scalability. Conclusions. HT&Me has been systematically and rigorously developed to promote AET adherence and improve QoL, and is complemented with a logic model documenting hypothesized mechanisms of action. An ongoing feasibility trial will inform a future randomised control trial of effectiveness and cost-effectiveness

The Active Brains Digital Intervention to Reduce Cognitive Decline in Older Adults: Protocol for a Feasibility Randomized Controlled Trial.

BACKGROUND: Increasing physical activity, improving diet, and performing brain training exercises are associated with reduced cognitive decline in older adults. OBJECTIVE: In this paper, we describe a feasibility trial of the Active Brains intervention, a web-based digital intervention developed to support older adults to make these 3 healthy behavior changes associated with improved cognitive health. The Active Brains trial is a randomized feasibility trial that will test how accessible, acceptable, and feasible the Active Brains intervention is and the effectiveness of the study procedures that we intend to use in the larger, main trial. METHODS: In the randomized controlled trial (RCT), we use a parallel design. We will be conducting the intervention with 2 populations recruited through GP practices (family practices) in England from 2018 to 2019: older adults with signs of cognitive decline and older adults without any cognitive decline. Trial participants were randomly allocated to 1 of 3 study groups: usual care, the Active Brains intervention, or the Active Brains website plus brief support from a trained coach (over the phone or by email). The main outcomes are performance on cognitive tasks, quality of life (using EuroQol-5D 5 level), Instrumental Activities of Daily Living, and diagnoses of dementia. Secondary outcomes (including depression, enablement, and health care costs) and process measures (including qualitative interviews with participants and supporters) will also be collected. The trial has been approved by the National Health Service Research Ethics Committee (reference 17/SC/0463). RESULTS: Results will be published in peer-reviewed journals, presented at conferences, and shared at public engagement events. Data collection was completed in May 2020, and the results will be reported in 2021. CONCLUSIONS: The findings of this study will help us to identify and make important changes to the website, the support received, or the study procedures before we progress to our main randomized phase III trial. TRIAL REGISTRATION: International Standard Randomized Controlled Trial Number 23758980; http://www.isrctn.com/ISRCTN23758980. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/18929

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 (&lt;= 10 years previously) for colo-rectal, breast or prostate cancers, with European-Organization-for-Research-and-Treatment-of-Cancer QLQ-C30 score &lt;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 healthenablement and symptom management, with substantially lower NHS costs.<br/

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

Adolescent impulsivity and healthy eating - it's in the message

The effects of message format, message frame, and individual differences in impulsivity on fruit and vegetable consumptio