Project objectives

Primary objective

To develop and assess the feasibility of an intervention to proactively identity women at risk of familial breast cancer in primary care.

Secondary objective

To optimise study design for an exploratory trial evaluating the benefits and harms of the intervention.

This study addresses two key research questions:

1. Is proactive familial breast cancer risk assessment, using family history enquiry and decision support software, feasible and acceptable in primary care?
2. What is the most feasible and appropriate study design, including outcome measures and data collection methods, for an exploratory trial evaluating the benefits and harms of proactive familial breast cancer risk assessment intervention compared with current practice?

Changes to project objectives

We originally proposed 2 focus groups with the public, one with women recruited through media and women referred to hospital. Due to limited interest, these groups were merged into a single delayed focus group. Further details in section below.

Brief summary

Methods

The present study used a qualitative design and collected its data through focus groups and individual semi-structured interviews with General Practitioners (GP) and practice administrative staff over a 4 month period (January to April 2014). One focus group (N=7) was conducted with GPs from several General Practices in the Nottingham (including practices from Nottingham City, Nottingham North and East CCGs). One focus group was conducted with practice administrative staff (N=3) from one practice. Data collected from these focus groups was supplemented with semi-structured interviews with practice administrative staff (N =7) from three different surgeries. Participants were asked questions in accordance with the objectives of the study. Both the focus groups and interviews were transcribed and analysed using thematic analysis.

Women were recruited through newspaper adverts in Greater Nottingham area, and from familial breast cancer register at familial cancer service in Royal Derby hospital.

Main Findings from General Practice staff

Four main themes emerged from the data collected from both the focus groups and interviews. These are presented below under the two key research questions of the study:

Research question 1: Is proactive familial breast cancer risk assessment, using family history enquiry and decision support software, feasible and acceptable in primary care?

1. Collection of Family History
   All staff believed that the collection of family history through the Family History Questionnaire (FHQ) was a suitable method of obtaining these data.
2. Practice Training Needs for Staff
   Practice administrative staff advised that all administrative staff would need to be informed of the proposed intervention (offer eligible women to complete FHQ and practice administrative staff input the data on web-based risk assessment tool) in order to deal with patients queries to the practice. Staff thought that a step-by-step guide would be very helpful with using the risk assessment tool.
3. Ease of use of the Proposed Intervention for Practices
   Practice administrative staff perceived the web-based risk assessment tool to be easy and straight-forward to use. Some staff suggested that receptionists could help enter data during quiet periods in the practice. Some staff also recommended that the letters generated from the risk assessment tool could be produced by the clinical system to save time entering patient contact details.

Research question 2: What is the most feasible and appropriate study design for an exploratory trial evaluating the benefits and harms of proactive familial breast cancer risk assessment intervention compared with current practice?

1. Refinement of Recruitment Processes
   GPs discussed concerns about the referral process and discussed that the intervention would need to be clear about which patients need to be referred to secondary services. They recommended having a specific person at the Familial Cancer Services to discuss patients’ family histories when they were unclear about the referral process. They also recommended that patients involved in the study should be seen by GPs and not practice nurses.
   Practice administrative staff were concerned about increased workload and time to process the patients’ FHQs. They suggested sending FHQs to the surgeries in small batches and research team liaising regularly with the administrative team would be beneficial.
2. Refinement of Study Documentation for Patients and Practices
   Participants suggested minor changes to a few of the study documents. However, in general, all participants thought the study documentation produced for both the patients and practice staff was clear and well-worded.

Main findings from Public focus group

Despite several newspaper adverts only one woman was identified (retired professional with history of breast cancer). Further an invitation to join focus groups was sent to 12 women who had attended familial breast cancer risk assessment at Royal Derby hospital. Following invitation only three women agreed to participate (two women were at high familial risk of breast cancer, one woman was at moderate risk of the disease). Due to hospital research governance delays and lack of response to newspaper advert the focus group could not be setup until after first 2 intervention general practices were setup for feasibility study.

With limited interested women from familial cancer service and woman identified by newspaper advert were combined into a single focus group. Similar research questions to general practice were explored, but greater emphasis on material produced.

Research question 1: Is proactive familial breast cancer risk assessment, using family history enquiry and decision support software, feasible and acceptable in primary care?

Women were positive about the approach and could not understand why this had not been considered previously. They thought that the information sheet contained a lot of information to comprehend. However, they made some suggestions as to how the information can be presented (i.e., restructuring the information sheet, making it clear in the initial information as to why they were being approached) and key questions potential participants may want to know before taking part in the study. The group discussed the difficulties of obtaining family histories of cancer (e.g. due to family dynamics), but mentioned that these are mostly unavoidable. Although, they believed that it is beneficial to share family histories where possible. The information leaflets were considered to be useful, although minor amendments would be required. The study procedures for participants at low or non-significant risk of breast cancer were considered appropriate. With regards to participants at high risk and requiring referral, they felt strongly that these participants should been seen by the GPs to discuss their referral to the Familial Cancer Services.

Research question 2: What is the most feasible and appropriate study design for an exploratory trial evaluating the benefits and harms of proactive familial breast cancer risk assessment intervention compared with current practice?

The women did not feel they had the experience to explore this study design issue but were concerned with some general practitioners suggestion of referring women after telephone call through choose and book system. They indicated women at higher enough familial breast cancer risk to need referral should be seen by general practitioner in the practice before referral. They also mentioned that it might be helpful to know whether the outcome questionnaire was completed before or after complete the FHQ as this may affect responses.

Conclusion

To conclude, the proposed method of assessing woman’s risk of developing breast cancer is seen as acceptable and feasible to implement into primary care by both general practice staff and potential participants. With women highlighting feedback of increased familial risk, after completing FHQ, should be given to women in person. Recommendations for improvements will be used in the next stage of this study. Further, 3 of the 4 women have agreed to continue in Phase 2 of the Familial Breast Cancer study as a local PPI group. This will augment our PPI activity through local research group representative and national partners (Breakthrough Breast Cancer).

Plain English summary

Background

Breast cancer is the most common cancer for women in the UK, with up to 30% of women having an inherited predisposition to cancer. This means that it can be passed from family members to the affected individual. Early recognition of increased familial risk enables increased surveillance. Breast cancer can be detected early, dramatically reducing morbidity and improving life expectancy. However, a large number of women at high risk (50%) and moderate risk (25%) are not being identified.

The risk of hereditary breast cancer can be identified by a detailed family history. This can be challenging, but effectively collected using a self-administered family history questionnaire. We propose inviting women registered in general practice to complete a family history questionnaire and general practice administrative staff collating this information in a web-based family history risk assessment tool to identify women at high familial risk of breast cancer, with care plans for clinicians to manage these women. Prior to testing this tool, we will explore the barriers and facilitators to this approach with women and general practice staff.

Findings

General Practice clinical and administrative staff participated in focus groups and interviews, and were asked questions about using the proposed risk assessment tool. All were audio-recorded and transcribed and analysed using thematic analysis.

All practice staff perceived that the collection of family histories, through the use of a questionnaire, was an appropriate method. They also perceived the web-based risk assessment tool to be easy and straight-forward to use, and made suggestions of how the tool could be used alongside their clinical systems. General Practitioners expressed concerns about the process of referring patients and this would need to be clearly presented by the decision support tool. In addition, a key specialist contact needs to be available. Administrative staff were concerned with the increase in their workload, but suggested that regular communication with the research team regarding the processing of family histories would be important. The discussion with recruited women  suggested minor changes to participant documentation and perceived that the approach should not cause anxiety. However, they did suggest General Practitioners should see high risk women before referral.

Conclusion

The proposed method of assessing woman’s risk of developing breast cancer is seen as acceptable and feasible to implement by general practice staff and potential participants. Recommendations for improvements will be used in the next stage of this study.

Dissemination

Published articles

Our related work on the NICE familial breast cancer guidelines have been published:

1. Qureshi, N. O’Flynn, N., Evans, G. (2014).Dealing with family history of breast cancer: something new, something old. BJGP. DOI: 10.3399/bjgp14X676267.
   http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3876167/
2. Qureshi, N. & Evans, G. (2013). Family history is key to risk classification of familial breast cancer. Guideline in Practice, 16(8), pp37-45.
   http://www.guidelinesinpractice.co.uk/aug_13_qureshi_cancer_aug13#.VZ-4Xk3Qfcs

Planned articles

The findings are planned to be published findings in peer-reviewed health service journals.

Poster presentations

Preliminary findings from the FBC study are to be presented as a poster at The European Society of Human Genetics 2015 (Title: From National Guideline Recommendations to Familial Cancer Risk Assessment Decision Support in Primary Care: UK Experience).

Public involvement

A patient and public involvement group was developed from women who had attended the original focus group. They have supported the systematic identification of eligible women in primary care and suggested an amended care pathway. Also, our national PPI partners (Breakthrough Breast Cancer) are exploring strategies to disseminate our approach nationally.

The PPI representatives have provided useful feedback on how to improve elements of study design for a further exploratory trial. They highlighted amendments required to the study documentation to ensure participants are aware of the reasons why they are being approached and how their information is used.

Impact

The approach has been presented to healthcare policy makers at the joint Meeting of the All-Party Parliamentary Groups (APPG) on Breast and Ovarian Cancer on 28 January 2014.

With the national charity, Breakthrough Breast Cancer, we have collaborated on a poster presentation at the Royal College for GPs annual conference titled ‘Breast Cancer in the Family New national guidelines, patient perspectives and what the guidelines mean for primary care’.

Also, following feasibility study, the East Midlands Academic Health Science Network is exploring adopting this as a regional demonstration project as an exemplar for translating national guidelines into clinical practice.

This project was funded by the National Institute for Health Research School for Primary Care Research (project number 205)

Department of Health Disclaimer

The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the NIHR School for Primary Care Research, NIHR, NHS or the Department of Health.