How do women at increased risk of breast cancer make sense of their risk? An interpretative phenomenological analysis.

OBJECTIVES: Offering breast cancer risk prediction for all women of screening age is being considered globally. For women who have received a clinically derived estimate, risk appraisals are often inaccurate. This study aimed to gain an in-depth understanding of women's lived experiences of receiving an increased breast cancer risk. DESIGN: One-to-one semi-structured telephone interviews. METHODS: Eight women informed that they were at a 10-year above-average (moderate) or high risk in a breast cancer risk study (BC-Predict) were interviewed about their views on breast cancer, personal breast cancer risk and risk prevention. Interviews lasted between 40 and 70 min. Data were analysed using Interpretative Phenomenological Analysis. RESULTS: Four themes were generated: (i) encounters with breast cancer and perceived personal significance, where the nature of women's lived experiences of others with breast cancer impacted their views on the significance of the disease, (ii) 'It's random really': difficulty in seeking causal attributions, where women encountered contradictions and confusion in attributing causes to breast cancer, (iii) believing versus identifying with a clinically-derived breast cancer risk, where personal risk appraisals and expectations influenced women's ability to internalize their clinically derived risk and pursue preventative action and (iv) perceived utility of breast cancer risk notification, where women reflected on the usefulness of knowing their risk. CONCLUSIONS: Providing (numerical) risk estimates appear to have little impact on stable yet internally contradictory beliefs about breast cancer risk. Given this, discussions with healthcare professionals are needed to help women form more accurate appraisals and make informed decisions.

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.

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).

The role of knowledge, primary care and community engagement to improve breast-screening access for Pakistani women in the United Kingdom: A secondary analysis of a qualitative study.

OBJECTIVE: Breast cancer incidence is rising among Pakistani women in the United Kingdom. However, uptake of breast screening remains low. This study aimed to improve access to breast screening for British-Pakistani women by exploring their knowledge of breast cancer and the role of primary care and community networks to support screening access amongst British-Pakistani women. METHODS: We undertook a secondary qualitative analysis of 18 semi-structured interviews with British-Pakistani women from East Lancashire in the United Kingdom. Anonymized transcripts of the interviews were used for a thematic analysis. RESULTS: Three themes were identified in the interviewees' responses: (i) 'Women's knowledge of breasts and breast cancer', which described how a cultural taboo exists around Pakistani women's bodies and around breast cancer; (ii) 'Role of primary care', which detailed how General Practitioners can support informed decisions and offer a trusted and valued information source; (iii) 'Community engagement', which described the potential to disseminate breast-screening information through the whole community, including primary care providers, all family members and mosques. CONCLUSIONS: Our analysis suggested three main targets for future interventions to improve access to breast screening for British-Pakistani women: (i) co-produced strategies to increase knowledge of breasts and breast screening; (ii) greater collaboration with local General Practitioners to support women to make informed choices about screening; and (iii) community engagement involving General Practitioners and community leaders, to inform everyone - not just screening-age women - about breast cancer and screening.

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.

The co-development of personalised 10-year breast cancer risk communications: a 'think-aloud' study.

BACKGROUND: Risk stratified breast cancer screening is being considered as a means of improving the balance of benefits and harms of mammography. Stratified screening requires the communication of risk estimates. We aimed to co-develop personalised 10-year breast cancer risk communications for women attending routine mammography. METHODS: We conducted think-aloud interviews on prototype breast cancer risk letters and accompanying information leaflets with women receiving breast screening through the UK National Breast Screening Programme. Risk information was redesigned following feedback from 55 women in three iterations. A deductive thematic analysis of participants' speech is presented. RESULTS: Overall, participants appreciated receiving their breast cancer risk. Their comments focused on positive framing and presentation of the risk estimate, a desire for detail on the contribution of individual risk factors to overall risk and effective risk management strategies, and clearly signposted support pathways. CONCLUSION: Provision of breast cancer risk information should strive to be personal, understandable and meaningful. Risk information should be continually refined to reflect developments in risk management. Receipt of risk via letter is welcomed but concerns remain around the acceptability of informing women at higher risk in this way, highlighting a need for co-development of risk dissemination and support pathways.

What are the views of three key stakeholder groups on extending the breast screening interval for low-risk women? A secondary qualitative analysis.

INTRODUCTION: There is increasing interest in risk-stratified breast screening, whereby the prevention and early detection offers vary by a woman's estimated risk of breast cancer. To date, more focus has been directed towards high-risk screening pathways rather than considering women at lower risk, who may be eligible for extended screening intervals. This secondary data analysis aimed to compare the views of three key stakeholder groups on how extending screening intervals for low-risk women should be implemented and communicated as part of a national breast screening programme. METHODS: Secondary data analysis of three qualitative studies exploring the views of distinct stakeholder groups was conducted. Interviews took place with 23 low-risk women (identified from the BC-Predict study) and 17 national screening figures, who were involved in policy-making and implementation. In addition, three focus groups and two interviews were conducted with 26 healthcare professionals. A multiperspective thematic analysis was conducted to identify similarities and differences between stakeholders. FINDINGS: Three themes were produced: Questionable assumptions about negative consequences, highlighting how other stakeholders lack trust in how women are likely to understand extended screening intervals; Preserving the integrity of the programme, centring on decision-making and maintaining a positive reputation of breast screening and Negotiating a communication pathway highlighting communication expectations and public campaign importance. CONCLUSIONS: A risk-stratified screening programme should consider how best to engage women assessed as having a low risk of breast cancer to ensure mutual trust, balance the practicality of change whilst ensuring acceptability, and carefully develop multilevel inclusive communication strategies. PATIENT AND PUBLIC CONTRIBUTION: The research within this paper involved patient/public contributors throughout including study design and materials input.

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.

The feasibility of implementing risk stratification into a national breast cancer screening programme: a focus group study investigating the perspectives of healthcare personnel responsible for delivery.

BACKGROUND: Providing women with personalized estimates of their risk of developing breast cancer, as part of routine breast cancer screening programmes, allows women at higher risk to be offered more frequent screening or drugs to reduce risk. For this to be feasible, the concept and practicalities have to be acceptable to the healthcare professionals who would put it in to practice. The present research investigated the acceptability to healthcare professionals who were responsible for the implementation of this new approach to screening in the ongoing BC-Predict study. METHODS: Four focus groups were conducted with 29 healthcare professionals from a variety of professional backgrounds working within three breast screening services in north-west England. An inductive-manifest thematic analysis was conducted. RESULTS: Overall, healthcare professionals viewed the implementation of personalised breast cancer risk estimation as a positive step, but discussion focused on concerns. Three major themes are presented. (1) Service constraints highlights the limited capacity within current breast services and concerns about the impact of additional workload. (2) Risk communication concerns the optimal way to convey risk to women within resource constraints. (3) Accentuating inequity discusses how risk stratification could decrease screening uptake for underserved groups. CONCLUSIONS: Staff who implemented risk stratification considered it a positive addition to routine screening. They considered it essential to consider improving capacity and demands on healthcare professional time. They highlighted the need for skilled communication of risks and new pathways of care to ensure that stratification could be implemented in financially and time constrained settings without impacting negatively on women.

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.

Extending screening intervals for women at low risk of breast cancer: do they find it acceptable?

BACKGROUND: Trials of risk estimation in breast cancer screening programmes, in order to identify women at higher risk and offer extra screening/preventive measures, are ongoing. It may also be feasible to introduce less frequent screening for women at low-risk of breast cancer. This study aimed to establish views of women at low-risk of breast cancer regarding the acceptability of extending breast screening intervals for low-risk women beyond 3 y. METHODS: Semi-structured interviews were used to explore views of low-risk women, where "low-risk" was defined as less than 2% estimated 10-year risk of breast cancer aged > 46 years. Low-risk women were identified via the BC-Predict study, where following routine screening, women were given their 10-year risk of breast cancer by letter, along with additional information explaining breast cancer risk factors. To gain diversity of views, purposive sampling by ethnicity and socioeconomic background was used to recruit women. Data were analysed using thematic analysis. RESULTS: Twenty-three women participated in individual interviews. Three themes are reported: (1) A good opportunity to receive risk estimation, where women found it worthwhile to receive a low-risk result although some were surprised if expecting a higher risk result; (2) Multi-faceted acceptability of extended screening intervals, with reactions to less frequent screening dependent on whether women were confident in being low-risk status and current safety evidence, (3) Passive approval versus informed choice, highlighting that women found it difficult to consider choosing less frequent screening without professionals' recommendations, as they generally viewed attending breast screening as positive. CONCLUSIONS: Risk assessment and receiving a low-risk of breast cancer is acceptable although, further research is required with more diverse samples of women. Any recommendation of less frequent screening in this risk group should be evidence-based in order to be acceptable. Communication needs to be carefully developed, with a focus on ensuring informed choice, prior to trialling any extended screening recommendations in future studies.

Introducing a low-risk breast screening pathway into the NHS Breast Screening Programme: Views from healthcare professionals who are delivering risk-stratified screening.

OBJECTIVES: Proposals to stratify breast screening by breast cancer risk aim to produce a better balance of benefits to harms. Notably, risk estimation calculated from common risk factors and a polygenic risk score would enable high-risk women to benefit from more frequent screening or preventive medication. This service would also identify low-risk women who experience fewer benefits from attending, as lower grade and in situ cancers may be treated unnecessarily. It may therefore be appropriate for low-risk women to attend screening less. This study aimed to elicit views regarding implementing less frequent screening for low-risk women from healthcare professionals who implement risk-stratified screening. METHODS: Healthcare professionals involved in the delivery of risk-stratified breast screening were invited to participate in a focus group within the screening setting in which they work or have a telephone interview. Primary care staff were also invited to provide their perspective. Three focus groups and two telephone interviews were conducted with 28 healthcare professionals. To identify patterns across the sample, data were analysed as a single dataset using reflexive thematic analysis. RESULTS: Analysis yielded three themes: Reservations concerning the introduction of less frequent screening, highlighting healthcare professionals' unease and concerns towards implementing less frequent screening; Considerations for the management of public knowledge, providing views on media impact on public opinion and the potential for a low-risk pathway to cause confusion and raise suspicion regarding implementation motives; and Deliberating service implications and reconfiguration management, where the practicalities of implementation are discussed. CONCLUSIONS: Healthcare professionals broadly supported less frequent screening but had concerns about implementation. It will be essential to address concerns regarding risk estimate accuracy, healthcare professional confidence, service infrastructure and public communication prior to introducing less frequent screening for low-risk women.

Risk stratified breast cancer screening: UK healthcare policy decision-making stakeholders' views on a low-risk breast screening pathway.

BACKGROUND: There is international interest in risk-stratification of breast screening programmes to allow women at higher risk to benefit from more frequent screening and chemoprevention. Risk-stratification also identifies women at low-risk who could be screened less frequently, as the harms of breast screening may outweigh benefits for this group. The present research aimed to elicit the views of national healthcare policy decision-makers regarding implementation of less frequent screening intervals for women at low-risk. METHODS: Seventeen professionals were purposively recruited to ensure relevant professional group representation directly or indirectly associated with the UK National Screening Committee and National Institute for Health and Care Excellence (NICE) clinical guidelines. Interviews were analysed using thematic analysis. RESULTS: Three themes are reported: (1) producing the evidence defining low-risk, describing requirements preceding implementation; (2) the impact of risk stratification on women is complicated, focusing on gaining acceptability from women; and (3) practically implementing a low-risk pathway, where feasibility questions are highlighted. CONCLUSIONS: Overall, national healthcare policy decision-makers appear to believe that risk-stratified breast screening is acceptable, in principle. It will however be essential to address key obstacles prior to implementation in national programmes.

What are the benefits and harms of risk stratified screening as part of the NHS breast screening Programme? Study protocol for a multi-site non-randomised comparison of BC-predict versus usual screening (NCT04359420).

BACKGROUND: In principle, risk-stratification as a routine part of the NHS Breast Screening Programme (NHSBSP) should produce a better balance of benefits and harms. The main benefit is the offer of NICE-approved more frequent screening and/ or chemoprevention for women who are at increased risk, but are unaware of this. We have developed BC-Predict, to be offered to women when invited to NHSBSP which collects information on risk factors (self-reported information on family history and hormone-related factors via questionnaire; mammographic density; and in a sub-sample, Single Nucleotide Polymorphisms). BC-Predict produces risk feedback letters, inviting women at high risk (≥8% 10-year) or moderate risk (≥5 to < 8% 10-year) to have discussion of prevention and early detection options at Family History, Risk and Prevention Clinics. Despite the promise of systems such as BC-Predict, there are still too many uncertainties for a fully-powered definitive trial to be appropriate or ethical. The present research aims to identify these key uncertainties regarding the feasibility of integrating BC-Predict into the NHSBSP. Key objectives of the present research are to quantify important potential benefits and harms, and identify key drivers of the relative cost-effectiveness of embedding BC-Predict into NHSBSP. METHODS: A non-randomised fully counterbalanced study design will be used, to include approximately equal numbers of women offered NHSBSP (n = 18,700) and BC-Predict (n = 18,700) from selected screening sites (n = 7). In the initial 8-month time period, women eligible for NHSBSP will be offered BC-Predict in four screening sites. Three screening sites will offer women usual NHSBSP. In the following 8-months the study sites offering usual NHSBSP switch to BC-Predict and vice versa. Key potential benefits including uptake of risk consultations, chemoprevention and additional screening will be obtained for both groups. Key potential harms such as increased anxiety will be obtained via self-report questionnaires, with embedded qualitative process analysis. A decision-analytic model-based cost-effectiveness analysis will identify the key uncertainties underpinning the relative cost-effectiveness of embedding BC-Predict into NHSBSP. DISCUSSION: We will assess the feasibility of integrating BC-Predict into the NHSBSP, and identify the main uncertainties for a definitive evaluation of the clinical and cost-effectiveness of BC-Predict. TRIAL REGISTRATION: Retrospectively registered with clinicaltrials.gov (NCT04359420).

The introduction of risk stratified screening into the NHS breast screening Programme: views from British-Pakistani women.

BACKGROUND: UK national guidelines suggest women at high-risk of breast cancer should be offered more frequent screening or preventative medications. Currently, only 1 in 6 high-risk women are identified. One route to identify more high-risk women is via multifactorial risk assessment as part of the UK's NHS Breast Screening Programme (NHSBSP). As lower socioeconomic and minority ethnic populations continue to experience barriers to screening, it is important that any new service does not exacerbate issues further. To inform service development, this study explored views of women from underserved backgrounds regarding the introduction of risk stratification into the NHSBSP. METHODS: Nineteen semi-structured interviews were conducted with British-Pakistani women from low socioeconomic backgrounds from East Lancashire, UK. Fourteen interviews were conducted via an interpreter. RESULTS: Thematic analysis produced three themes. Attitudes toward risk awareness concerns the positive views women have toward the idea of receiving personalised breast cancer risk information. Anticipated barriers to accessibility emphasises the difficulties associated with women's limited English skills for accessing information, and their I.T proficiency for completing an online risk assessment questionnaire. Acceptability of risk communication strategy highlights the diversity of opinion regarding the suitability of receiving risk results via letter, with the option for support from a healthcare professional deemed essential. CONCLUSIONS: The idea of risk stratification was favourable amongst this underserved community. To avoid exacerbating inequities, this new service should provide information in multiple languages and modalities and offer women the opportunity to speak to a healthcare professional about risk. This service should also enable completion of personal risk information via paper questionnaires, as well as online.

Engagement barriers and service inequities in the NHS Breast Screening Programme: Views from British-Pakistani women.

OBJECTIVES: Previous research has largely attempted to explore breast screening experiences of South Asian women by combining opinions from Pakistani, Bangladeshi, and Indian women. This research often fails to reach the most underserved sub-groups of this population, with socioeconomic status not routinely reported, and English fluency being a participation requirement. With uptake low amongst British-Pakistani women, this study explores the experiences these women encounter when accessing the NHS Breast Screening Programme. METHODS: 19 one-to-one semi-structured interviews were carried out with British-Pakistani women from East Lancashire, UK. 14 interviews were conducted via an interpreter. RESULTS: Data were analysed using thematic analysis. Three themes were identified: 'Absence of autonomy in screening and healthcare access' describes how currently the screening service does not facilitate confidentiality or independence. Access requires third-party intervention, with language barriers preventing self-expression. 'Appraisal of information sources' makes distinctions between community and NHS communication. Whereas community communication was invaluable, NHS materials were deemed inaccessible due to translation incongruences and incomprehensible terminology. 'Personal suppositions of breast screening' explores the subjective issues associated with disengagement, including, the cultural misalignment of the service, and perceiving screening as a symptomatic service. CONCLUSIONS: British-Pakistani women face some unique challenges when accessing breast screening. To promote uptake, the service needs to address the translation of screening materials and optimize upon community networks to disseminate knowledge, including knowledge of the screening environment within the context of culture to promote informed choice about attendance.