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). CONCLUSIONS: The evidence-base on ET adherence determinants is extensive. Future empirical studies should focus on less well-researched areas and settings. The determinants themselves are numerous and complex in indicating that adherence support should be multifaceted, addressing multiple determinants.

Experiences of using a supported digital intervention for cancer survivors in primary care: a qualitative process evaluation.

BACKGROUND: Increasing healthy behaviours (e.g. physical activity) can improve cancer survivors' quality of life. Renewed is a digital intervention developed to provide behaviour change advice with brief healthcare practitioner support. A three-arm randomised controlled trial (Renewed, Renewed with support or a control condition) suggested that prostate cancer survivors in the supported arm had slightly greater estimates of improvements in quality of life compared to other cancer survivors. This study explored participants' experiences using Renewed to understand how it might have worked and why it might have provided greater benefit for prostate cancer survivors and those in the supported arm. METHODS: Thirty-three semi-structured telephone interviews with cancer survivors' (breast, colorectal, prostate) from the Renewed trial explored their experiences of using Renewed and their perceptions of the intervention. Data were analysed using inductive thematic analysis. RESULTS: Some participants only used Renewed modestly but still made behaviour changes. Barriers to using Renewed included low perceived need, joining the study to advance scientific knowledge or 'to give back', or due to perceived availability of support in their existing social networks. Prostate cancer survivors reported less social support outside of Renewed compared to participants with other cancers. CONCLUSION: Renewed may support healthy behaviour changes among cancer survivors even with limited use. Interventions targetting individuals who lack social support may be beneficial. IMPLICATIONS FOR CANCER SURVIVORS: Cancer survivors' experiences may inform the development of digital interventions to better serve this population.

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.

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.

Parallel randomized controlled feasibility trials of the "Active Brains" digital intervention to protect cognitive health in adults aged 60-85.

Introduction: Multidomain interventions to address modifiable risk factors for dementia are promising, but require more cost-effective, scalable delivery. This study investigated the feasibility of the "Active Brains" digital behavior change intervention and its trial procedures. Materials and methods: Active Brains aims to reduce cognitive decline by promoting physical activity, healthy eating, and online cognitive training. We conducted 12-month parallel-design randomized controlled feasibility trials of "Active Brains" amongst "lower cognitive scoring" (n = 180) and "higher cognitive scoring" (n = 180) adults aged 60-85. Results: We collected 67.2 and 76.1% of our 12-month primary outcome (Baddeley verbal reasoning task) data for the "lower cognitive score" and "higher cognitive score" groups, respectively. Usage of "Active Brains" indicated overall feasibility and satisfactory engagement with the physical activity intervention content (which did not require sustained online engagement), but engagement with online cognitive training was limited. Uptake of the additional brief telephone support appeared to be higher in the "lower cognitive score" trial. Preliminary descriptive trends in the primary outcome data might indicate a protective effect of Active Brains against cognitive decline, but further investigation in fully-powered trials is required to answer this definitively. Discussion: Whilst initial uptake and engagement with the online intervention was modest, it was in line with typical usage of other digital behavior change interventions, and early indications from the descriptive analysis of the primary outcome and behavioral data suggest that further exploration of the potential protective benefits of Active Brains are warranted. The study also identified minor modifications to procedures, particularly to improve online primary-outcome completion. Further investigation of Active Brains will now seek to determine its efficacy in protecting cognitive performance amongst adults aged 60-85 with varied levels of existing cognitive performance.

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 plays an important role in supporting survivors of cancer; however, support is limited because of practitioners' perceived lack of expertise and time. A digital intervention for survivors of cancer could provide an efficient way for primary care staff to support survivors of cancer without the need to accumulate expertise and skills to help patients make behavior changes; providing very brief support alongside this could maximize adherence to digital interventions. Renewed is a digital intervention that combines web-based behavior change advice with brief health care practitioner support from a nurse or health care assistant. Knowledge about the views and experiences of primary care staff providing support alongside a digital intervention for survivors of cancer is sparse, limiting the understanding of the acceptability and feasibility of this type of intervention. OBJECTIVE: This study aims to explore supporters' experiences of providing support to survivors of cancer using Renewed, understand potential barriers to and facilitators of the implementation of Renewed in practice, and investigate the strengths and weaknesses of the intervention from the perspective of health care professionals. METHODS: This was a qualitative process evaluation nested within a large trial evaluating Renewed. A total of 28 semistructured telephone interviews were conducted with nurses and health care assistants. Data were analyzed using inductive thematic analysis. RESULTS: Four themes were developed during the analysis, which reflected the factors that supporters identified as hindering or enabling them to provide support alongside Renewed Online: Renewed Online as an acceptable digital tool with some improvements, confidence in enacting 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 in supporting survivors of cancer in primary care and fit within current practices. However, barriers to providing support alongside the intervention were also identified, including concerns about how to facilitate rapport building and, in a minority, concerns about using a nondirective approach, in which most advice and support is provided through digital interventions, with brief additional support provided by primary care staff. CONCLUSIONS: These findings add to the literature on how best to provide support alongside digital interventions, suggesting that although most practitioners cope well with a nondirective approach, a minority requires more training to feel confident in implementing this. This study suggests that the barriers to providing formal support to survivors of cancer in primary care could be successfully overcome with an approach such as Renewed, where a digital intervention provides most of the support and expertise, and health care practitioners provide additional brief human support to maximize engagement. Strategies to maximize the chances of successful implementation for this type of intervention are also discussed.

Optimising an intervention to support home-living older adults at risk of malnutrition: a qualitative study.

BACKGROUND: In the UK, about 14% of community-dwelling adults aged 65 and over are estimated to be at risk of malnutrition. Screening older adults in primary care and treating those at risk may help to reduce malnutrition risk, reduce the resulting need for healthcare use and improve quality of life. Interventions are needed to raise older adults' risk awareness, offer relevant and meaningful strategies to address risk and support general practices to deliver treatment and support. METHODS: Using the Person-based Approach and input from Patient and Public Involvement representatives, we developed the 'Eat well, feel well, stay well' intervention. The intervention was optimised using qualitative data from think aloud and semi-structured process evaluation interviews with 23 and 18 older adults respectively. Positive and negative comments were extracted to inform rapid iterative modifications to support engagement with the intervention. Data were then analysed thematically and final adjustments made, to optimise the meaningfulness of the intervention for the target population. RESULTS: Participants' comments were generally positive. This paper focuses predominantly on participants' negative reactions, to illustrate the changes needed to ensure that intervention materials were optimally relevant and meaningful to older adults. Key factors that undermined engagement included: resistance to the recommended nutritional intake among those with reduced appetite or eating difficulties, particularly frequent eating and high energy options; reluctance to gain weight; and a perception that advice did not align with participants' specific personal preferences and eating difficulties. We addressed these issues by adjusting the communication of eating goals to be more closely aligned with older adults' beliefs about good nutrition, and acceptable and feasible eating patterns. We also adjusted the suggested tips and strategies to fit better with older adults' everyday activities, values and beliefs. CONCLUSIONS: Using iterative qualitative methods facilitated the identification of key behavioural and contextual elements that supported engagement, and issues that undermined older adults' engagement with intervention content. This informed crucial revisions to the intervention content that enabled us to maximise the meaningfulness, relevance and feasibility of the key messages and suggested strategies to address malnutrition risk, and therefore optimise engagement with the intervention and the behavioural advice it provided.

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

BACKGROUND: By 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. METHODS: During 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. RESULTS: Scoping 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. CONCLUSIONS: A 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.

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.

A Qualitative Exploration of Perceptions of a Digital Intervention to Promote Physical Activity in Older Adults.

PURPOSE: This study explored participant views of a web-based physical activity intervention for older adults and examined how they resonate with the key principles that guided intervention development. METHODS: Qualitative interviews were carried out with 52 older adults. A deductive qualitative analysis approach was taken, based around the intervention's key principles. RESULTS: Participants expressed mostly positive views of the intervention features, broadly confirming the appropriateness of the key principles, which were to: (a) encourage intrinsic motivation for physical activity, (b) minimize the risk of users receiving activity suggestions that are inappropriate or unsafe, (c) offer users choice regarding the activities they engage with and build confidence to undertake more activity, and (d) minimize the cognitive load and need to engage with the intervention website. The findings also identified ways in which content could be improved to further increase acceptability. CONCLUSION: This study illustrates how using the person-based approach has enabled the identification and implementation of features that older adults appreciate.

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.

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.

Barriers and facilitators to screening and treating malnutrition in older adults living in the community: a mixed-methods synthesis.

BACKGROUND: Malnutrition (specifically undernutrition) in older, community-dwelling adults reduces well-being and predisposes to disease. Implementation of screen-and-treat policies could help to systematically detect and treat at-risk and malnourished patients. We aimed to identify barriers and facilitators to implementing malnutrition screen and treat policies in primary/community care, which barriers have been addressed and which facilitators have been successfully incorporated in existing interventions. METHOD: A data-base search was conducted using MEDLINE, Embase, PsycINFO, DARE, CINAHL, Cochrane Central and Cochrane Database of Systematic Reviews from 2012 to June 2016 to identify relevant qualitative and quantitative literature from primary/community care. Studies were included if participants were older, community-dwelling adults (65+) or healthcare professionals who would screen and treat such patients. Barriers and facilitators were extracted and mapped onto intervention features to determine whether these had addressed barriers. RESULTS: Of a total of 2182 studies identified, 21 were included (6 qualitative, 12 quantitative and 3 mixed; 14 studies targeting patients and 7 targeting healthcare professionals). Facilitators addressing a wide range of barriers were identified, yet few interventions addressed psychosocial barriers to screen-and-treat policies for patients, such as loneliness and reluctance to be screened, or healthcare professionals' reservations about prescribing oral nutritional supplements. CONCLUSION: The studies reviewed identified several barriers and facilitators and addressed some of these in intervention design, although a prominent gap appeared to be psychosocial barriers. No single included study addressed all barriers or made use of all facilitators, although this appears to be possible. Interventions aiming to implement screen-and-treat approaches to malnutrition in primary care should consider barriers that both patients and healthcare professionals may face. REVIEW REGISTRATIONS: PROSPERO: CRD42017071398 . The review protocol was registered retrospectively.

Exploring cancer survivors' views of health behaviour change: "Where do you start, where do you stop with everything?"

OBJECTIVE: Physical activity (PA) and a healthy diet can improve the well-being of cancer survivors. However, cancer survivors often do not engage in these behaviours. This study aimed to explore barriers and facilitators to engaging in these behaviours following cancer treatment. METHODS: During the development of a Web-based intervention to enhance health-related quality of life in cancer survivors, 32 people who had completed treatment for breast, colon, or prostate cancer were presented with an intervention for PA and healthy eating. In-depth think-aloud and semi-structured interviewing techniques were used to elicit perceptions of both behaviours. Data were analysed using thematic analysis. RESULTS: Some individuals reported implementing positive health behaviour changes to maintain health and prevent recurrence, or to help them to move forward after cancer. However, others reported feeling abandoned, and many did not report an intention to engage in lifestyle changes. Individuals discussed contextual and health-related barriers that were specifically linked to their situation as post-treatment cancer survivors: individuals described uncertainty about how to implement adaptive changes and perceived a lack of support from health care providers. Others viewed behaviour change as unnecessary or undesirable, with some arguing that non-modifiable factors contributed more to their cancer diagnosis than lifestyle-related factors. CONCLUSIONS: For many participants in this study, the period that follows treatment for cancer did not represent a "teachable moment." A variety of complex and heterogeneous factors appeared to impact motivation and may limit cancer survivors from engaging with diet and PA changes.