Correction: Evaluating the Acceptance and Usability of an App Promoting Weight Gain Prevention and Healthy Behaviors Among Young Women With a Family History of Breast Cancer: Protocol for an Observational Study.

[This corrects the article DOI: 10.2196/41246.].

Evaluating the Acceptance and Usability of an App Promoting Weight Gain Prevention and Healthy Behaviors Among Young Women With a Family History of Breast Cancer: Protocol for an Observational Study.

BACKGROUND: Breast cancer is the most common form of cancer in women, and around 20% of cases are associated with factors such as adult weight gain, overweight and obesity, and potentially modifiable health behaviors including high alcohol intake, smoking, lack of physical activity, and breastfeeding. Significant weight gain occurs between the ages of 18 and 35 years; hence, this age group could benefit from weight gain prevention interventions. Population studies have reported that women at increased risk of breast cancer account for a disproportionate amount of cases. Thus, there is a particular need to target weight gain prevention and other health behavior interventions for women at increased risk. A literature review identified no evidence-based apps that cover all relevant health behaviors. With patient and participant involvement from the target population, we have developed a new app to promote healthy behaviors among young women at increased risk of breast cancer. Alongside the app, a Facebook group provides peer support, and a virtual welcome event provides an overview of the project and the opportunity to meet the research team and other study participants. The aim of the intervention is to prevent weight gain via changes to eating habits and physical activity levels, and improve other health behaviors associated with breast cancer. The app includes goal setting and self-monitoring of health behaviors and provides education about breast cancer. OBJECTIVE: This study aims to assess the acceptability and usability of the app in young women at increased risk of breast cancer, and the feasibility of the study procedures for a future, larger efficacy study. METHODS: Young women (n=35, age 18-35 years) at increased risk of breast cancer (>17% lifetime risk) will be recruited via 2 recruitment procedures: mailed invite from the local breast cancer family history, risk and prevention clinic, and advertisements on social media and websites. Participants will have access to the app and the private Facebook group for 2 months. They will complete questionnaires regarding their health behaviors and breast cancer risk belief at the start and end of the study, complete app rating scales in the middle and at the end of the study, and be invited to give feedback on the app during the study period. Approximately 20 participants will have a semistructured interview at the end of the study regarding their views on the app and trial procedures. RESULTS: The trial is ongoing, and the publication of results is anticipated in 2023. CONCLUSIONS: The trial will provide evidence regarding the acceptability and usability of the newly developed app for young women at increased risk of breast cancer. Feedback obtained will be used to improve the app. The trial will also assess the feasibility of the study procedures and how these can be refined for a future efficacy study. TRIAL REGISTRATION: ClinicalTrials.gov NCT05460650; https://clinicaltrials.gov/ct2/show/NCT05460650. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/41246.

Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the "My Personal Breast Screening" (MyPeBS) randomised clinical trial.

BACKGROUND: The MyPeBS study is an ongoing randomised controlled trial testing whether a risk-stratified breast cancer screening strategy is non-inferior, or eventually superior, to standard age-based screening at reducing incidence of stage 2 or more cancers. This large European Commission-funded initiative aims to include 85,000 women aged 40 to 70 years, without prior breast cancer and not previously identified at high risk in six countries (Belgium, France, Italy, Israel, Spain, UK). A specific work package within MyPeBS examines psychological, socio-economic and ethical aspects of this new screening strategy. It compares women's reported data and outcomes in both trial arms on the following issues: general anxiety, cancer-related worry, understanding of breast cancer screening strategy and information-seeking behaviour, socio-demographic and economic characteristics, quality of life, risk perception, intention to change health-related behaviours, satisfaction with the trial. METHODS: At inclusion, 3-months, 1-year and 4-years, each woman participating in MyPeBS is asked to fill online questionnaires. Descriptive statistics, bivariate analyses, subgroup comparisons and analysis of variations over time will be performed with appropriate tests to assess differences between arms. Multivariate regression models will allow modelling of different patient reported data and outcomes such as comprehension of the information provided, general anxiety or cancer worry, and information seeking behaviour. In addition, a qualitative study (48 semi-structured interviews conducted in France and in the UK with women randomised in the risk-stratified arm), will help further understand participants' acceptability and comprehension of the trial, and their experience of risk assessment. DISCUSSION: Beyond the scientific and medical objectives of this clinical study, it is critical to acknowledge the consequences of such a paradigm shift for women. Indeed, introducing a risk-based screening relying on individual biological differences also implies addressing non-biological differences (e.g. social status or health literacy) from an ethical perspective, to ensure equal access to healthcare. The results of the present study will facilitate making recommendations on implementation at the end of the trial to accompany any potential change in screening strategy. TRIAL REGISTRATION: Study sponsor: UNICANCER. My personalised breast screening (MyPeBS). CLINICALTRIALS: gov (2018) available at: https://clinicaltrials.gov/ct2/show/NCT03672331 Contact: Cécile VISSAC SABATIER, PhD, + 33 (0)1 73 79 77 58 ext + 330,142,114,293, contact@mypebs.eu.

Supporting People With Type 2 Diabetes in the Effective Use of Their Medicine Through Mobile Health Technology Integrated With Clinical Care to Reduce Cardiovascular Risk: Protocol for an Effectiveness and Cost-effectiveness Randomized Controlled Trial.

BACKGROUND: Type 2 diabetes is a common lifelong condition that affects over 400 million people worldwide. The use of effective medications and active self-management can reduce the risk of serious complications. However, people often have concerns when starting new medications and face difficulties in taking their medications regularly. Support provided by brief messages delivered through mobile phone-based SMS text messages can be effective in some long-term conditions. We have identified promising behavior change techniques (BCTs) to promote medication adherence in this population via a systematic review and developed SMS text messages that target these BCTs. Feasibility work has shown that these messages have fidelity to intended BCTs, are acceptable to patients, and are successful in changing the intended determinants of medication adherence. We now plan to test this intervention on a larger scale in a clinical trial. OBJECTIVE: The aim of this trial is to determine the effectiveness and cost-effectiveness of this intervention for reducing cardiovascular risk in people with type 2 diabetes by comparing it with usual care. METHODS: The trial will be a 12-month, multicenter, individually randomized controlled trial in primary care and will recruit adults (aged ≥35 years) with type 2 diabetes in England. Consenting participants will be randomized to receive short SMS text messages intended to affect a change in medication adherence 3 to 4 times per week in addition to usual care. The aim is to test the effectiveness and cost-effectiveness of the intervention when it is added to usual care. The primary clinical outcome will be a composite cardiovascular risk measure. Data including patient-reported measures will be collected at baseline, at 13 and 26 weeks, and at the end of the 12-month follow-up period. With 958 participants (479 in each group), the trial is powered at 92.5% to detect a 4-percentage point difference in cardiovascular risk. The analysis will follow a prespecified plan. A nested quantitative and qualitative process analysis will be used to examine the putative mechanisms of behavior change and wider contextual influences. A health economic analysis will be used to assess the cost-effectiveness of the intervention. RESULTS: The trial has completed the recruitment phase and is in the follow-up phase. The publication of results is anticipated in 2024. CONCLUSIONS: This trial will provide evidence regarding the effectiveness and cost-effectiveness of this intervention for people with type 2 diabetes. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15952379; https://www.isrctn.com/ISRCTN15952379. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32918.

Differences in Older Adults Walking Football Initiation and Maintenance Influences Across Respondent Characteristics: A Cross-Sectional Survey.

Despite health benefits gained from physical activity and sport participation, older adults are less likely to be active. This study investigates what influences 50- to 75-year-olds (N = 439) to initiate and maintain walking football, across gender, socioeconomic status, number of health conditions, and physical activity level. It also considers relationships between participant characteristics and influences, and intentions to play after a forced break (COVID-19). Results of a U.K. online cross-sectional survey found those with two or more health conditions rated social influences significantly higher in initiation and maintenance than participants with no health conditions. Multiple regression analysis found a positive walking football culture, and perceived use of maintenance resources contributed significantly to intentions to return to play after COVID-19 restrictions eased. Practitioners should consider providing opportunities for social connection, foster a positive walking football culture, and encourage players to utilize maintenance resources (e.g., scheduling sessions) in older adult walking football sessions.

Impact of the Enhanced Universal Support Offer to Care Homes during COVID-19 in the UK: Evaluation using appreciative inquiry.

There are over 2,300 care homes in the North East and Yorkshire Region, with rising rates of COVID-19 infection in April 2020. The Enhanced Universal Support Offer (EUSO) planned to improve support to care homes, working collaboratively with local integrated community services. Implementation was organised at 'place', through clinical commissioning and it was focused on leadership, prevention, additional clinical support, and workforce planning. The aim of the evaluation research was to understand the impact of the EUSO. The evaluation was co-produced by a group of senior leaders with additional academic involvement. An appreciative inquiry approach informed the interviews and focus groups with representative stakeholders. A thematic analysis using NVivo enabled a validation process and the data were charted into a systems framework. Data analysis resulted in five high level themes: Communication, Working Relationships, Systemic Perceptions, COVID-19 Implementation, and Organisational Support. Best practices were associated with joint working between health, local authority and care homes including medication optimisation and technology use. Care homes valued access to a named General Practitioner and community nursing working as a part of a wider multidisciplinary team. Conversely an overly reactive response to care homes combined with 'command and control' limited the benefits that were achieved. The EUSO was delivered at pace and resulted in an increased appreciation of the policy and principles of care home residents and workforce. The evaluation reflected a need to appreciate the care homes' knowledge and experience of resident wellbeing, and more fully involve them in the design of the support.

The Contribution of Pharmacists and Pharmacy Technicians to Person-Centred Care within a Medicine's Optimisation in Care Homes Service: A Qualitative Evaluation.

Pharmacists and pharmacy technicians seek to improve person-centred care. Improvements to systems for care homes seeks to reduce medicines waste and inefficiency, particularly through supporting care home staff, to enhance safer administration of medicines. A complex evaluation used qualitative design and utilised narrative enquiry, and team members and key stakeholders were interviewed. Framework analysis was used, aligning findings to a person-centred care framework for older people. The Medicines Optimisation in Care Homes (MOCH) team brokered improvement practices across care homes to enhance person-centred care. The framework analysis confirms that the team used 'authentic attention' in relation to the residents' experiences and flexibility in relation to negotiating medication. The importance of transparency of processes and systems in medicines management is highlighted, alongside requirements for person-centred care to make explicit the reason for taking a medication, and the continuous discussion with a range of stakeholders about the continuing need for particular medications. The outcome of the evaluation includes insights into a new area of pharmacy practice in community, based on the skills, knowledge, and experience of pharmacists and pharmacy technicians working in the care home sector. Further study is needed into the efficacy and outcomes of medicines management interventions.

Experiences and Strategies Influencing Older Adults to Continue Playing Walking Football.

Adults aged 55+ years are most likely to be inactive, despite research suggesting that older adults experience multiple benefits when participating in physical activity and sport. Limited research focuses on long-term continuation of sport participation in this population, especially in "adapted sports" like walking football. This study explored the experiences of walking football maintenance in 55- to 75-year-old players. Semistructured interviews were conducted, with 17 older adults maintaining walking football play over 6 months. The inductive analysis revealed five higher-order themes representing maintenance influences and two higher-order themes relating to maintenance mechanisms (i.e., the conscious process by which players maintain). Influences when maintaining walking football included individual- and culture-level influences (e.g., perceived benefits of maintenance and ability acceptance). Maintenance mechanisms included cognitions and behaviors (e.g., scheduling sessions and redefining physical activity expectations). Findings highlight novel implications for policy and practice, which are important to consider when delivering walking football to older adults.

Experiences Influencing Walking Football Initiation in 55- to 75-Year-Old Adults: A Qualitative Study.

Adults aged 55 and older are least likely to play sport. Despite research suggesting this population experiences physical and psychological benefits when doing so, limited research focuses on older adult sport initiation, especially in "adapted sports" such as walking football. The aim of this study was to explore initiation experiences of walking football players between 55 and 75 years old. Semistructured interviews took place with 17 older adults playing walking football for 6 months minimum (Mage = 64). Inductive analysis revealed six higher order themes representing preinitiation influences. Eight further higher order themes were found, relating to positive and negative experiences during initiation. Fundamental influences preinitiation included previous sporting experiences and values and perceptions. Emergent positive experiences during initiation included mental development and social connections. Findings highlight important individual and social influences when initiating walking football, which should be considered when encouraging 55- to 75-year-old adults to play adapted sport. Policy and practice recommendations are discussed.