Acceptability of personalised risk-based breast cancer screening v1.0
Research type
Research Study
Full title
Acceptability of personalised risk-based breast cancer screening and prevention approaches among women in Europe
IRAS ID
202669
Contact name
D. Gareth Evans
Contact email
Sponsor organisation
University Hospital of South Manchester
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
Research Summary:
Rationale: To counter the increasing burden of breast cancer for European women, better strategies for primary and secondary prevention are urgently needed. Personalised risk-based approaches may help target screening and primary prevention for breast cancer to women who will benefit most while sparing costs and complications among women who would experience less benefit. However, little is known about the acceptability of personalised approaches, especially for women at low risk, and the challenges of implementation, providing the rationale for the current proposal.Objective: To provide insight in the acceptability of personalised risk-based breast cancer screening and primary prevention approaches for European women.
Study design: A mixed method study combining qualitative research methods (concept mapping and focus groups) with quantitative research (online questionnaire survey).Study population: Women aged 47-73 years.
Main study parameters/endpoints: The main study parameter is acceptance of personalised risk-based breast cancer screening. The endpoint will be reached using the following three methods:
1. Concept mapping with healthcare professionals. Concept mapping is a qualitative interview approach to assessing which aspects professionals (n=15-20) feel might affect women’s perceptions on personalised risk-based breast cancer screening and primary prevention (time investment 60 minutes).
2. Focus group interviews will be organised to identify unforeseen topics that may not arise from the literature search (n = 20-50). Focus group discussions will be organised until thematic saturation has been achieved. The discussions will be recorded and transcribed verbatim and anonymously in the original language (English). The information from the transcripts will be analysed using a systematic six-step strategy by Braun and Clarke (2006). The results from the interviews will be used in the construction of a questionnaire survey.
3. An online questionnaire survey will be conducted, made-up out of items identified through the systematic literature search and the focus group interviews, among a representative sample of women (n = 250-500) using different hypothetical risk-based screening and primary prevention scenarios. The aim of the questionnaire survey is to gain quantitative insight into the predictors of acceptance of personalised risk-based breast cancer screening. Multivariate logistic regression will be performed to identify predictors of compliance with personalised risk-based breast cancer screening and primary prevention approaches.Summary of Resuts:
: Currently the NHS Breast Screening Programme offers breast cancer screening to all women aged 50 to 70 years, inviting them for a mammogram every three years. Screening reduces breast cancer mortality by detecting breast cancer at an earlier stage when there are better treatment options. However, false-positive test results and overdiagnosis are well-documented harms of screening. More knowledge of breast cancer risk factors may allow for a shift from current one-size-fits-all screening to risk-based screening. This may improve the benefit-harm ratio of screening. With risk-based screening a woman’s screening intensity will be informed by their breast cancer risk. This could, for instance, mean that women with a lower risk will receive less intensive screening, whereas women at increased risk will be screened more intensively. The present study looked at the acceptability and implementation of risk-based breast cancer screening from the perspectives of healthcare professionals and screening attendees. We used a variety of methods to gauge acceptability and implementation preferences.We invited British healthcare professionals to think about potential advantages and disadvantages of risk-based screening for eligible women. They identified seven areas that may influence a woman’s decision-making process about participation in risk-based screening: (1) Proactive approach; (2) Anxiety/worry; (3) Organisation of risk assessment and feedback; (4) Lack of knowledge; (5) Psychological impact of knowing risk; (6) Concerns about accuracy; and (7) Acceptance of risk without intervention.
Additionally, we organised focus group discussions with women who had previously participated in the Predicting Risk of Cancer at Screening (PROCAS) study for which they had provided breast cancer risk information. Subsequently they had received their breast cancer risk and risk-based screening and prevention recommendations. During the focus group discussions women evaluated their experiences and talked about the effect risk-based screening had on their wellbeing. Women were satisfied with the format in which their risk was presented to them. Low- and average-risk were satisfied receiving their risk in an information letter. Women at increased risk appreciated the option of a telephone or face-to-face consultation. They would appreciate a written report of the consultation. Some women at increased risk felt unprepared for the consequences of the risk assessment, thinking too lightly of it. Women at increased risk were concerned about the lack of knowledge of some GPs regarding preventative medication for breast cancer. Women signalled a need for pathways and protocols to standardise interaction between primary and secondary care providers to avoid individual variation. The costs of additional mammography in Britain were only covered by the country's National Health Service (NHS) for high-risk women who were under 60 years old. The costs of preventative medication were also not covered. Women feared that the principle of solidarity in healthcare finance and delivery will be hindered. Therefore, they called for policy changes to ensure equal access.
We also administered an online survey to PROCAS study participants to explore which factors were associated with women’s uptake of screening and prevention recommendations after risk communication. Additionally, we evaluated women’s organisational preferences. We found that women’s self-reported breast cancer risk predicted the uptake of (a) supplemental screening and breast self-examination, (b) risk-reducing medication and (c) preventive lifestyle behaviours. Further predictors were (a) having a first degree relative with breast cancer, (b) higher age, and (c) higher body mass index (BMI). Women’s organisational preferences for risk-based screening emphasised a desire for more intensive screening for women at increased risk by further shortening the screening interval and moving the starting age forward.
REC name
London - Central Research Ethics Committee
REC reference
16/LO/0925
Date of REC Opinion
14 Jun 2016
REC opinion
Further Information Favourable Opinion