Emotion constructs and outcome measures following false positive breast screening test results: A systematic review of reporting clarity and selection rationale.

OBJECTIVE: (i) To systematically identify constructs and outcome measures used to assess the emotional and mood impact of false positive breast screening test results; (ii) to appraise the reporting clarity and rationale for selecting constructs and outcome measures. METHODS: Databases (MEDLINE, CINAHL, PsycINFO) were systematically searched from 1970. Studies using standardised and non-standardised outcome measures to evaluate the emotion or mood impact of false positive breast screening test results were eligible. A 15-item coding scheme was devised to appraise articles on clarity and rationale for selected constructs and measures. RESULTS: Forty-seven articles were identified. The most investigated constructs were general anxiety and depression and disease-specific anxiety and worry. Twenty-two standardised general outcome questionnaire measures and three standardised disease-specific outcome questionnaire measures were identified. Twenty articles used non-standardised scales/items. Reporting of constructs and outcome measures was generally clear, but rationales for their selection were lacking. Anxiety was typically justified, but justification for depression was almost always absent. Practical and psychometric justification for selecting outcome measures was lacking, and theoretical rationale was absent. CONCLUSIONS: Heterogeneity in constructs and measures, coupled with unclear rationale for these, impedes a thorough understanding of why there are emotional effects of false positive screening test results. This may explain the repeated practice of investigating less relevant outcomes such as depression. There is need to develop a consensual conceptual model of and standardised approach to measuring emotional impact from cancer screening test results, to address heterogeneity and other known issues of interpreting an inconsistent evidence base.

Healthcare professionals' experiences of caring for women with false-positive screening test results in the National Health Service Breast Screening Programme.

BACKGROUND: Understanding healthcare professionals' (HCPs) experiences of caring for women with false-positive screening test results in the National Health Service Breast Screening Programme (NHSBSP) is important for reducing the impact of such results. METHODS: Interviews were undertaken with 12 HCPs from a single NHSBSP unit, including advanced radiographer practitioners, breast radiographers, breast radiologists, clinical nurse specialists (CNSs), and a radiology healthcare assistant. Data were analysed thematically using Template Analysis. RESULTS: Two themes were produced: (1) Gauging and navigating women's anxiety during screening assessment was an inevitable and necessary task for all participants. CNSs were perceived as particularly adept at this, while breast radiographers reported a lack of adequate formal training. (2) Controlling the delivery of information to women (including amount, type and timing of information). HCPs reported various communication strategies to facilitate women's information processing and retention during a distressing time. CONCLUSIONS: Women's anxiety could be reduced through dedicated CNS support, but this should not replace support from other HCPs. Breast radiographers may benefit from more training to emotionally support recalled women. While HCPs emphasised taking a patient-centred communication approach, the use of other strategies (e.g., standardised scripts) and the constraints of the 'one-stop shop' model pose challenges to such an approach. PATIENT AND PUBLIC CONTRIBUTION: During the study design, two Patient and Public Involvement members (women with false-positive-breast screening test results) were consulted to gain an understanding of patient perspectives and experiences of being recalled specifically in the NHSBSP. Their feedback informed the formulations of the research aim, objectives and the direction of the interview guide.

An app promoting weight gain prevention via healthy behaviours amongst young women with a family history of breast cancer: Acceptability and usability assessment.

BACKGROUND: Breast cancer is the most frequent female malignancy in the UK. Around 20% of cases are linked to weight gain, excess weight and health behaviours. We designed a weight gain prevention, health behaviour intervention for young women at increased risk. METHODS: The study comprised a single arm observational study over 2 months testing acceptability and usability of the intervention: online group welcome event, app and private Facebook group. Females aged 18-35 years at moderate or high risk of breast cancer (>17% lifetime risk) were recruited via invite letters and social media posts. The app included behaviour change techniques and education content. Online questionnaires were completed at baseline, as well as at 1 and 2 months. We also assessed feasibility of study procedures. RESULTS: Both recruitment methods were successful. Thirty-five women were recruited, 26% via social media posts. Median age was 33 (interquartile range = 28.2-34.5) years, the majority (94.1%) were of White ethnicity. Thirty-four participants were included in the analyses, of which 94% downloaded the app. Median self-monitoring logs per participant during the study period was 10.0 (interquartile range = 4.8-28.8). App quality mean (SD) score was 3.7 (0.6) at 1 and 2 months (scale: 1-5). Eighty-nine per cent rated the app at average or above at 1 month and 75.0% at 2 months. Nineteen women (55.9%) joined the Facebook group and there were 61 comments and 83 reactions and votes from participants during the study period. CONCLUSIONS: This first iteration of the app and intervention was well received and is suitable to progress to the next stage of refining and further testing.

Acceptability of Four Intervention Components Supporting Medication Adherence in Women with Breast Cancer: a Process Evaluation of a Fractional Factorial Pilot Optimization Trial.

Adjuvant endocrine therapy (AET) reduces mortality in early-stage breast cancer, but adherence is low. We developed a multicomponent intervention to support AET adherence comprising: text messages, information leaflet, acceptance and commitment therapy (ACT), and side-effect website. Guided by the multiphase optimization strategy, the intervention components were tested in the ROSETA pilot optimization trial. Our mixed-methods process evaluation investigated component acceptability. The pilot optimization trial used a 24-1 fractional factorial design. Fifty-two women prescribed AET were randomized to one of eight experimental conditions, containing unique component combinations. An acceptability questionnaire was administered 4 months post-randomization, and semi-structured interviews with 20 participants further explored acceptability. Assessments were guided by four constructs of the theoretical framework of acceptability: affective attitude, burden, perceived effectiveness, and coherence. Quantitative and qualitative findings were triangulated to identify agreements/disagreements. There were high overall acceptability scores (median = 14-15/20, range = 11-20). There was agreement between the qualitative and quantitative findings when triangulated. Most participants "liked" or "strongly liked" all components and reported they required low effort to engage in. Between 50% (leaflet) and 65% (SMS) "agreed" or "strongly agreed," it was clear how each component would help adherence. Perceived effectiveness was mixed, with 35.0% (text messages) to 55.6% (ACT) of participants "agreeing" or "strongly agreeing" that each component would improve their adherence. Interview data provided suggestions for improvements. The four components were acceptable to women with breast cancer and will be refined. Mixed-methods and triangulation were useful methodological approaches and could be applied in other optimization trial process evaluations.

What do women think about having received their breast cancer risk as part of a risk-stratified NHS Breast Screening Programme? A qualitative study.

BACKGROUND: Risk-stratified screening is being considered for national breast screening programmes. It is unclear how women experience risk-stratified screening and receipt of breast cancer risk information in real time. This study aimed to explore the psychological impact of undergoing risk-stratified screening within England's NHS Breast Screening Programme. METHODS: Individual telephone interviews were conducted with 40 women who participated in the BC-Predict study and received a letter indicating their estimated breast cancer risk as one of four risk categories: low (<2% 10-year risk), average (2-4.99%), above average (moderate; 5-7.99%) or high (≥8%). Audio-recorded interview transcriptions were analysed using reflexive thematic analysis. RESULTS: Two themes were produced: 'From risk expectations to what's my future health story?' highlights that women overall valued the opportunity to receive risk estimates; however, when these were discordant with perceived risk, this causes temporary distress or rejection of the information. 'Being a good (woman) citizen' where women felt positive contributing to society but may feel judged if they then cannot exert agency over the management of their risk or access follow-up support CONCLUSIONS: Risk-stratified breast screening was generally accepted without causing long-lasting distress; however, issues related to risk communication and access to care pathways need to be considered for implementation.

Psychological impact of risk-stratified screening as part of the NHS Breast Screening Programme: multi-site non-randomised comparison of BC-Predict versus usual screening (NCT04359420).

BACKGROUND: Adding risk stratification to standard screening via the NHS Breast Screening Programme (NHSBSP) allows women at higher risk to be offered additional prevention and screening options. It may, however, introduce new harms such as increasing cancer worry. The present study aimed to assess whether there were differences in self-reported harms and benefits between women offered risk stratification (BC-Predict) compared to women offered standard NHSBSP, controlling for baseline values. METHODS: As part of the larger PROCAS2 study (NCT04359420), 5901 women were offered standard NHSBSP or BC-Predict at the invitation to NHSBSP. Women who took up BC-Predict received 10-year risk estimates: "high" (≥8%), "above average (moderate)" (5-7.99%), "average" (2-4.99%) or "below average (low)" (<2%) risk. A subset of 662 women completed questionnaires at baseline and at 3 months (n = 511) and 6 months (n = 473). RESULTS: State anxiety and cancer worry scores were low with no differences between women offered BC-Predict or NHSBSP. Women offered BC-Predict and informed of being at higher risk reported higher risk perceptions and cancer worry than other women, but without reaching clinical levels. CONCLUSIONS: Concerns that risk-stratified screening will produce harm due to increases in general anxiety or cancer worry are unfounded, even for women informed that they are at high risk.

Randomised controlled trial of breast cancer and multiple disease prevention weight loss programmes vs written advice amongst women attending a breast cancer family history clinic.

BACKGROUND: Overweight and obesity are common amongst women attending breast cancer Family History, Risk and Prevention Clinics (FHRPCs). Overweight increases risk of breast cancer (BC) and conditions including1 cardiovascular disease (CVD) and type-2 diabetes (T2D). Clinics provide written health behaviour advice with is likely to have minimal effects. We assessed efficacy of two remotely delivered weight loss programmes vs. written advice. METHOD: 210 women with overweight or obesity attending three UK FHRPCs were randomised to either a BC prevention programme (BCPP) framed to reduce risk of BC (n = 86), a multiple disease prevention programme (MDPP) framed to reduce risk of BC, CVD and T2D (n = 87), or written advice (n = 37). Change in weight and health behaviours were assessed at 12-months. RESULTS: Weight loss at 12 months was -6.3% (-8.2, -4.5) in BCPP, -6.0% (-7.9, -4.2) in MDPP and -3.3% (-6.2, -0.5) in the written group (p = 0.451 across groups). The percentage losing ≥10% weight in these groups were respectively 34%, 23% and 14% (p = 0.038 across groups). DISCUSSION: BCPP and MDPP programmes resulted in more women achieving ≥10% weight loss, but no evidence of additional benefits of MDPP. A multicentre RCT to test the BCPP across UK FHRPCs is warranted. Clinical Trial Registration ISRCTN16431108.

Proactive breast cancer risk assessment in primary care: a review based on the principles of screening.

In the UK, the National Institute for Health and Care Excellence (NICE) recommends that women at moderate or high risk of breast cancer be offered risk-reducing medication and enhanced breast screening/surveillance. In June 2022, NICE withdrew a statement recommending assessment of risk in primary care only when women present with concerns. This shift to the proactive assessment of risk substantially changes the role of primary care, in effect paving the way for a primary care-based screening programme to identify those at moderate or high risk of breast cancer. In this article, we review the literature surrounding proactive breast cancer risk assessment within primary care against the consolidated framework for screening. We find that risk assessment for women under 50 years currently satisfies many of the standard principles for screening. Most notably, there are large numbers of women at moderate or high risk currently unidentified, risk models exist that can identify those women with reasonable accuracy, and management options offer the opportunity to reduce breast cancer incidence and mortality in that group. However, there remain a number of uncertainties and research gaps, particularly around the programme/system requirements, that need to be addressed before these benefits can be realised.

Quantifying the effects of risk-stratified breast cancer screening when delivered in real time as routine practice versus usual screening: the BC-Predict non-randomised controlled study (NCT04359420).

BACKGROUND: Risk stratification as a routine part of the NHS Breast Screening Programme (NHSBSP) could provide a better balance of benefits and harms. We developed BC-Predict, to offer women when invited to the NHSBSP, which collects standard risk factor information; mammographic density; and in a sub-sample, a Polygenic Risk Score (PRS). METHODS: Risk prediction was estimated primarily from self-reported questionnaires and mammographic density using the Tyrer-Cuzick risk model. Women eligible for NHSBSP were recruited. BC-Predict produced risk feedback letters, inviting women at high risk (≥8% 10-year) or moderate risk (≥5-<8% 10-year) to have appointments to discuss prevention and additional screening. RESULTS: Overall uptake of BC-Predict in screening attendees was 16.9% with 2472 consenting to the study; 76.8% of those received risk feedback within the 8-week timeframe. Recruitment was 63.2% with an onsite recruiter and paper questionnaire compared to <10% with BC-Predict only (P < 0.0001). Risk appointment attendance was highest for those at high risk (40.6%); 77.5% of those opted for preventive medication. DISCUSSION: We have shown that a real-time offer of breast cancer risk information (including both mammographic density and PRS) is feasible and can be delivered in reasonable time, although uptake requires personal contact. Preventive medication uptake in women newly identified at high risk is high and could improve the cost-effectiveness of risk stratification. TRIAL REGISTRATION: Retrospectively registered with clinicaltrials.gov (NCT04359420).

Acceptability of prehabilitation for cancer surgery: a multi-perspective qualitative investigation of patient and 'clinician' experiences.

BACKGROUND: 'Prehabilitation' interventions aim to enhance individuals' physical fitness prior to cancer treatment, typically involve exercise training as a key component, and may continue to support physical activity, strength, and fitness during or after treatment. However, uptake of prehabilitation is variable. This study investigated how patients from diverse socio-economic status groups perceived an exemplar prehabilitation and recovery programme, aiming to understand factors impacting acceptability, engagement and referral. METHODS: This research was conducted in the context of the Prehab4Cancer and Recovery Programme, a prehabilitation and recovery programme available across Greater Manchester, UK. Qualitative, semi-structured phone/video-call interviews were conducted with 18 adult patient participants referred to the programme (16 'engagers', 2 'non-engagers'; half the sample lived in localities with low socio-economic status scores). An online questionnaire with free-response and categorical-response questions was completed by 24 'clinician' participants involved in referral (nurses, doctors and other staff roles). An inductive, multi-perspective, thematic analysis was performed, structured using the Framework approach. RESULTS: Discussing and referring patients to prehabilitation can be challenging due to large quantities of information for staff to cover, and for patients to absorb, around the time of diagnosis. The programme was highly valued by both participant groups; the belief that participation would improve recovery seemed a major motivator for engagement, and some 'clinicians' felt that prehabilitation should be treated as a routine part of treatment, or extended to support other patient groups. Engagers seemed to appreciate a supportive approach where they did not feel forced to do any activity and tailoring of the programme to meet individual needs and abilities was appreciated. Initial engagement could be daunting, but gaining experience with the programme seemed to increase confidence. CONCLUSIONS: The prehabilitation programme was highly valued by engagers. Introducing prehabilitation at a challenging time means that personalised approaches might be needed to support engagement, or participation could be encouraged at a later time. Strategies to support individuals lacking in confidence, such as buddying, may be valuable. STUDY REGISTRATION: The study protocol was uploaded onto the Open Science Framework 24 September 2020 ( https://osf.io/347qj/ ).

Impact of a prehabilitation and recovery programme on emotional well-being in individuals undergoing cancer surgery: a multi-perspective qualitative study.

BACKGROUND: Prehabilitation and recovery programmes aim to optimise patients' physical fitness and mental well-being before, during and after cancer treatment. This paper aimed to understand the impact of such a programme on emotional well-being in individuals undergoing cancer surgery. The programme was multi-modal, containing physical activity, well-being and nutritional support. METHODS: Qualitative interviews were conducted with 16 individuals who participated in a prehabilitation and recovery programme. Twenty-four health care staff involved in referral completed an online survey. An inductive, thematic analysis was conducted, integrating perspectives of patients and staff, structured with the Framework approach. RESULTS: Patients seemed to experience emotional benefits from the programme, appearing less anxious and more confident in their ability to cope with treatment. They seemed to value having something positive to focus on and control over an aspect of treatment. Ongoing, implicit psychological support provided by Exercise Specialists, who were perceived as expert, available and caring, seemed valued. Some patients appeared to appreciate opportunities to talk about cancer with peers and professionals. Discomfort with talking about cancer with other people, outside of the programme, was expressed. CONCLUSIONS: Participation in a prehabilitation and recovery programme appeared to yield valuable emotional well-being benefits, even without referral to specialist psychological support. STUDY REGISTRATION: The study protocol was uploaded onto the Open Science Framework 24 September 2020 ( https://osf.io/347qj/ ).

Preventing type 2 diabetes: A research agenda for behavioural science.

AIMS: The aim of this narrative review was to identify important knowledge gaps in behavioural science relating to type 2 diabetes prevention, to inform future research in the field. METHODS: Seven researchers who have published behaviour science research applied to type 2 diabetes prevention independently identified several important gaps in knowledge. They met to discuss these and to generate recommendations to advance research in behavioural science of type 2 diabetes prevention. RESULTS: A total of 21 overlapping recommendations for a research agenda were identified. These covered issues within the following broad categories: (a) evidencing the impact of whole population approaches to type 2 diabetes prevention, (b) understanding the utility of disease-specific approaches to type 2 diabetes prevention such as Diabetes Prevention Programmes (DPPs) compared to generic weight loss programmes, (c) identifying how best to increase reach and engagement of DPPs, whilst avoiding exacerbating inequalities, (d) the need to understand mechanism of DPPs, (e) the need to understand how to increase maintenance of changes as part of or following DPPs, (f) the need to assess the feasibility and effectiveness of alternative approaches to the typical self-regulation approaches that are most commonly used, and (g) the need to address emotional aspects of DPPs, to promote effectiveness and avoid harms. CONCLUSIONS: There is a clear role for behavioural science in informing interventions to prevent people from developing type 2 diabetes, based on strong evidence of reach, effectiveness and cost-effectiveness. This review identifies key priorities for research needed to improve existing interventions.

Optimization of an Information Leaflet to Influence Medication Beliefs in Women With Breast Cancer: A Randomized Factorial Experiment.

BACKGROUND: Adherence to adjuvant endocrine therapy (AET) is low in women with breast cancer. Negative beliefs about the necessity of AET and high concerns are barriers to adherence. PURPOSE: To use the multiphase optimization strategy to optimize the content of an information leaflet intervention, to change AET beliefs. METHODS: We conducted an online screening experiment using a 25 factorial design to optimize the leaflet. The leaflet had five components, each with two levels: (i) diagrams about AET mechanisms (on/off); (ii) infographics displaying AET benefits (enhanced/basic); (iii) AET side effects (enhanced/basic); (iv) answers to AET concerns (on/off); (v) breast cancer survivor (patient) input: quotes and photographs (on/off). Healthy adult women (n = 1,604), recruited via a market research company, were randomized to 1 of 32 experimental conditions, which determined the levels of components received. Participants completed the Beliefs about Medicines Questionnaire before and after viewing the leaflet. RESULTS: There was a significant main effect of patient input on beliefs about medication (ß = 0.063, p < .001). There was one significant synergistic two-way interaction between diagrams and benefits (ß = 0.047, p = .006), and one antagonistic two-way interaction between diagrams and side effects (ß = -0.029, p = .093). There was a synergistic three-way interaction between diagrams, concerns, and patient input (ß = 0.029, p = .085), and an antagonistic four-way interaction between diagrams, benefits, side effects, and concerns (ß = -0.038, p = .024). In a stepped approach, we screened in four components and screened out the side effects component. CONCLUSIONS: The optimized leaflet did not contain enhanced AET side effect information. Factorial experiments are efficient and effective for refining the content of information leaflet interventions.

Adjuvant endocrine therapy (AET) is a medication given to women to stop breast cancer from returning. Many women do not take AET every day or stop taking it before they should. Some women do not take AET because they do not believe it will help them, or they have concerns about the side effects. We ran an online study aiming to create the best information leaflet to help women understand how AET is helpful and to reduce their concerns. The leaflet had five sections; diagrams explaining how AET works, visual pictures of the benefits of AET, information about the side effects, answers to common concerns, and quotes from other women with breast cancer. 1,604 healthy women filled in a questionnaire before and after looking at an information leaflet about AET. Women received different combinations of the five sections of the information leaflet. We found quotes from other women with breast cancer led to more positive beliefs about AET. Some sections of the leaflet worked better in combination, while other sections were worse in combination. Our results led us to remove the detailed side effect information from the leaflet, as in combination with the other sections this negatively affected women's beliefs about AET.

"I don't know what I'm feeling for": young women's beliefs about breast cancer risk and experiences of breast awareness.

BACKGROUND: Younger women are often diagnosed with advanced breast cancer. Beliefs about risk are instrumental in motivating many health protective behaviours, but there may be confusion around which behaviour is appropriate to detect breast cancer earlier. Breast awareness, defined as an understanding of how the breasts look and feel so changes can be identified early, is widely recommended. In contrast, breast self-examination involves palpation using a specified method. We aimed to investigate young women's beliefs about their risk and experiences of breast awareness. METHODS: Thirty-seven women aged 30-39 years residing in a North West region of England with no family or personal history of breast cancer participated in seven focus groups (n = 29) and eight individual interviews. Data were analysed using reflexive thematic analysis. RESULTS: Three themes were generated. "Future me's problem" describes why women perceive breast cancer as an older woman's disease. Uncertainty regarding checking behaviours highlights how confusion about self-checking behaviour advice has resulted in women infrequently performing breast checks. Campaigns as a missed opportunity highlights the potential negative effects of current breast cancer fundraising campaigns and the perceived absence of educational campaigning about breast cancer for this demographic. CONCLUSIONS: Young women expressed low perceived susceptibility to developing breast cancer in the near future. Women did not know what breast self-checking behaviours they should be performing and expressed a lack of confidence in how to perform a breast check appropriately due to limited knowledge about what to look and feel for. Consequently, women reported disengagement with breast awareness. Defining and clearly communicating the best strategy for breast awareness and establishing whether it is beneficial or not are essential next steps.

Description of the nationally implemented National Health Service digital diabetes prevention programme and rationale for its development: mixed methods study.

BACKGROUND: The National Health Service (NHS) Digital Diabetes Prevention Programme (DDPP) is a behaviour change programme for adults in England who are at high risk of developing type 2 diabetes. Four independent providers deliver the NHS-DDPP following a competitive tendering process. Although providers work to a single service specification, there is potential for some variation in the service across providers. This study (1) assesses fidelity of the structural features of the design of the NHS-DDPP compared to the service specification, (2) describes the structural features of delivery of the NHS-DDPP as implemented (3) reports developers' views on how the structural components of the NHS-DDPP were developed and why changes were made following implementation. METHODS: Using mixed methods, we conducted a document review of providers' NHS-DDPP design and delivery documentation, and extracted information using the Template for Intervention Description and Replication checklist, which was adapted to capture features of digital delivery. Documentation was supplemented by content analysis of interviews with 12 health coaches involved in delivering the NHS-DDPP. Semi-structured interviews were also conducted with 6 programme developers employed by the digital providers. RESULTS: Provider plans for the NHS-DDPP show relatively high fidelity to the NHS service specification. Despite this, there was wide variation in structural features of delivery of the NHS-DDPP across providers, particularly for delivery of 'support' (e.g. use, dose and scheduling of health coaching and/or group support). Interviews with developers of the programmes showed that much of this variation is likely to be attributable to the origin of each provider's programme, which was usually a pre-existing programme that was adapted to conform to the NHS-DDPP service specification. The NHS-DDPP is continually improved and developed based on user experience feedback and research conducted by the providers. CONCLUSION: Indirect evidence suggests that variation in delivery of support could affect effectiveness of the NHS-DDPP. A priority for future research is ascertaining whether the variation in delivery of the NHS-DDPP across providers is related to any differences in health outcomes. It is recommended that future rounds of commissioning the NHS-DDPP pre-specify the type of support participants should receive, including expected dose and scheduling.

Implementing a text message-based intervention to support type 2 diabetes medication adherence in primary care: a qualitative study with general practice staff.

BACKGROUND: The Support through Mobile Messaging and digital health Technology for Diabetes (SuMMiT-D) project has developed, and is evaluating, a mobile phone-based intervention delivering brief messages targeting identified behaviour change techniques promoting medication use to people with type 2 diabetes in general practice. The present study aimed to inform refinement and future implementation of the SuMMiT-D intervention by investigating general practice staff perceptions of how a text message-based intervention to support medication adherence should be implemented within current and future diabetes care. METHODS: Seven focus groups and five interviews were conducted with 46 general practice staff (including GPs, nurses, healthcare assistants, receptionists and linked pharmacists) with a potential role in the implementation of a text message-based intervention for people with type 2 diabetes. Interviews and focus groups were audio-recorded, transcribed and analysed using an inductive thematic analysis approach. RESULTS: Five themes were developed. One theme 'The potential of technology as a patient ally' described a need for diabetes support and the potential of technology to support medication use. Two themes outlined challenges to implementation, 'Limited resources and assigning responsibility' and 'Treating the patient; more than diabetes medication adherence'. The final two themes described recommendations to support implementation, 'Selling the intervention: what do general practice staff need to see?' and 'Fitting the mould; complementing current service delivery'. CONCLUSIONS: Staff see the potential for a text message-based support intervention to address unmet needs and to enhance care for people with diabetes. Digital interventions, such as SuMMiT-D, need to be compatible with existing systems, demonstrate measurable benefits, be incentivised and be quick and easy for staff to engage with. Interventions also need to be perceived to address general practice priorities, such as taking a holistic approach to care and having multi-cultural reach and relevance. Findings from this study are being combined with parallel work with people with type 2 diabetes to ensure stakeholder views inform further refinement and implementation of the SuMMiT-D intervention.

How the Behavior Change Content of a Nationally Implemented Digital Diabetes Prevention Program Is Understood and Used by Participants: Qualitative Study of Fidelity of Receipt and Enactment.

BACKGROUND: The National Health Service Digital Diabetes Prevention Programme (NHS-DDPP) is a program for adults in England at risk of developing type 2 diabetes mellitus (T2DM). It is based on NHS England specifications that stipulate specific behavior change techniques (BCTs), that is, active ingredients to produce behavior change to target diet and physical activity. Now rolled out nationally, the NHS-DDPP is being delivered by 4 independent providers as a 9-month intervention via apps, educational material, and remote health coaching. To optimize effectiveness, participants need to be able to understand and use behavior change content (eg, goal setting and problem solving) of an intervention delivered to them digitally. Previous research has shown that people benefit from support to aid the understanding and use of BCTs. OBJECTIVE: The objectives of this qualitative study were to evaluate how participants in the NHS-DDPP understand and use BCT content, investigate how participants describe the role of health coaches in supporting their behavior change, and examine how the understanding and use of behavior change content of the NHS-DDPP varies across providers. METHODS: In total, 45 service users were interviewed twice by telephone at 2 to 4 months into, and at the end of, the program. Topics included participants' understanding and use of key BCTs to support self-regulation (eg, goal setting) and the support they received via the program. Transcripts were analyzed thematically, informed by the framework method. RESULTS: Participants described their understanding and use of some behavior change content of the program as straightforward: use of BCTs (eg, self-monitoring of behavior) delivered digitally via provider apps. Participants valued the role of health coaches in supporting their behavior change through the emotional support they offered and their direct role in delivery and application of some BCTs (eg, problem solving) to their specific circumstances. Participants expressed frustration over the lack of monitoring or feedback regarding their T2DM risk within the program. Variations in the understanding and use of behavior change content of the NHS-DDPP were present across provider programs. CONCLUSIONS: Health coaches' support in delivery of key components of the program seems to be pivotal. To improve the understanding and use of BCTs in digital interventions, it is important to consider routes of delivery that offer additional interactive human support. Understanding of some self-regulatory BCTs may benefit from this support more than others; thus, identifying the optimal mode of delivery for behavior change content is a priority for future research. The NHS-DDPP could be improved by explicitly setting out the need for health coaches to support understanding of some self-regulatory BCT content such as problem solving in the service specification and amending the discharge process so that knowledge of any change in T2DM risk is available to participants.

Codevelopment of a Text Messaging Intervention to Support Adherence to Adjuvant Endocrine Therapy in Women With Breast Cancer: Mixed Methods Approach.

BACKGROUND: Adjuvant endocrine therapy (AET) reduces breast cancer recurrence and mortality in women with early-stage breast cancer. Unintentional nonadherence to AET is common (eg, forgetting to take medication). Forming habits surrounding medication taking could reduce reliance on memory and improve AET adherence. SMS text messaging interventions may offer a low-cost approach for promoting medication-taking habits. To optimize the likely effectiveness of such SMS text messages, the content should be developed using a transparent approach to ensure fidelity to relevant psychological theory and with user input to increase acceptability. OBJECTIVE: This study aimed to develop a pool of brief SMS text messages promoting habit formation to support AET adherence, which are acceptable to women with breast cancer and show fidelity to theory-based behavior change techniques (BCTs). METHODS: According to published literature, we selected 6 BCTs derived from the habit formation model: action planning, habit formation, restructuring the physical environment, adding objects to the environment, prompts/cues, and self-monitoring of behavior. In study 1, behavior change experts (n=10) created messages, each based on 1 of the 6 BCTs, in a web-based workshop and rated the fidelity of the messages to the intended BCT. In study 2, women with experience of taking AET discussed the acceptability of the messages in a focus group (n=5), and the messages were refined following this. In study 3, women with breast cancer rated the acceptability of each message in a web-based survey (n=60). In study 4, additional behavior change experts rated the fidelity of the remaining messages to the intended BCT in a web-based survey (n=12). Finally, a consultant pharmacist reviewed a selection of messages to ensure that they did not contradict general medical advice. RESULTS: In study 1, 189 messages were created targeting the 6 BCTs. In total, 92 messages were removed because they were repetitious, unsuitable, or >160 characters, and 3 were removed because of low fidelity (scoring <5.5/10 on a fidelity rating scale). Following study 2, we removed 13 messages considered unacceptable to our target population. In study 3, all remaining messages scored above the midpoint on an acceptability scale (1-5); therefore, no messages were removed (mean 3.9/5, SD 0.9). Following study 4, we removed 13 messages owing to low fidelity (scoring <5.5/10 on a fidelity rating scale). All the remaining messages showed fidelity to the intended BCTs (mean 7.9/10, SD 1.3). Following the pharmacist review, 2 messages were removed, and 3 were amended. CONCLUSIONS: We developed a pool of 66 brief SMS text messages targeting habit formation BCTs to support AET adherence. These showed acceptability to women with breast cancer and fidelity to the intended BCTs. The delivery of the messages will be further evaluated to assess their effect on medication adherence.

How do women who are informed that they are at increased risk of breast cancer appraise their risk? A systematic review of qualitative research.

This review aimed to synthesise qualitative research on how women notified that they are at increased risk of breast cancer view their risk. Five electronic databases were systematically reviewed for qualitative research investigating how women who have received an increased breast cancer risk estimate appraise their risk status. Fourteen records reporting 12 studies were included and critically appraised. Data were thematically synthesised. Four analytical themes were generated. Women appraise their risk of breast cancer through comparison with their risk of other familial diseases. Clinically derived risk estimates were understood in relation to pre-conceived risk appraisals, with incongruences met with surprise. Family history is relied upon strongly, with women exploring similarities and differences in attributes between themselves and affected relatives to gauge the likelihood of diagnosis. Women at increased risk reported living under a cloud of inevitability or uncertainty regarding diagnosis, resulting in concerns about risk management. Women hold stable appraisals of their breast cancer risk which appear to be mainly formed through their experiences of breast cancer in the family. Healthcare professionals should explore women's personal risk appraisals prior to providing clinically derived risk estimates in order to address misconceptions, reduce concerns about inevitability and increase perceived control over risk reduction.

Circulating tumour DNA monitoring and early treatment for relapse: views from patients with early-stage melanoma.

BACKGROUND: Circulating tumour DNA (ctDNA) monitoring is a new technology that detects cancer DNA fragments in blood circulation. Regular monitoring with ctDNA has the potential to detect and treat cancer relapse earlier, but there is little evidence on patient acceptability. This study examines the views of patients with early-stage melanoma on the acceptability of the test and early treatment. METHODS: A qualitative cross-sectional design using one-to-one semi-structured telephone interviews was employed. Twenty-five patients diagnosed with early-stage melanoma (Stage IA-IIC) were asked for their views on ctDNA monitoring and early treatment for relapse. Interviews were analysed using reflexive thematic analysis. RESULTS: Two themes were generated: ctDNA monitoring would add service value where participants described regular ctDNA monitoring in follow-up care as more reassuring, more "scientific" than skin checks and preferable to scans. Test results provide opportunity and knowledge focuses on how participants wanted to know when to expect results to manage anxiety, with a positive result seen as an opportunity to receive treatment early. CONCLUSIONS: Participants were positive about ctDNA monitoring and early treatment and would welcome extra surveillance, as well as trust ctDNA tests. This indicates the feasibility of the wider implementation of ctDNA tests, which have applicability for many tumour types and disease stages.