Journals Library

Proactive familial breast cancer risk assessment in primary care - Phase 2

Project title

Proactive familial breast cancer risk assessment in primary care (Phase 2)

Project reference


Final report date

30 June 2016

Project start date

01 December 2013

Project end date

30 June 2016

Project duration

31 months

Project keywords

Breast Cancer, Family History, Primary Care, Genetics, NICE Guidelines, General practice

Lead investigator(s)
  • Professor Nadeem Qureshi, Clinical Professor, Faculty of Medicine & Health Sciences, University of Nottingham
  • Professor Joe Kai – Co-Investigator – University of Nottingham

  • Professor Denise Kendrick - Co-Investigator - University of Nottingham

  • Professor Kavita Vedhara - Co-Investigator - University of Nottingham

  • Dr Carol Coupland - Co-Investigator and Study Statistician - University of Nottingham

  • Professor Penny Standen - Co-Investigator - University of Nottingham

  • Stephen Weng – Research Fellow - University of Nottingham

  • Luke Robles – Research Fellow - University of Nottingham

  • Christina Brindley – Research Officer - University of Nottingham

  • Paula Dhiman – Research Fellow - University of Nottingham

  • Brittany Dutton – Research Administrator - University of Nottingham

  • Professor Gareth Evans – External Collaborator – University of Manchester

  • Mr Mark Sibbering - External Collaborator – Royal Derby Hospital

  • Mrs Wendy Chorley – External Collaborator – Royal Derby Hospital

  • Professor John Robertson - External Collaborator - University of Nottingham

  • Dr Caitlin Palframan - External Collaborator – Policy Officer Breakthrough Breast Cancer


Project objectives

This study aims to optimise the intervention using an exploratory trial design with nested qualitative study, to assess the feasibility of undertaking a large scale study.

Primary Objective

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

Secondary Objectives

To optimise study design for a definitive study evaluating the benefits and harms of the intervention.


Changes to Project

Due to a delay in practices referring patients to secondary care, the final stages of subsequent data collection was delayed. A no cost extension was approved to 30/06/2016 to enable the research team to collate the referral outcome data

Brief summary

This is a mixed methods study comprising exploratory randomised controlled trial with nested qualitative study.

 (a) Exploratory trial



Fifty-five General Practices within the South Derbyshire area were invited by letters to participate in the feasibility study. Working in collaboration with East Midlands CRN, 8 practices were recruited, matched by IMD (4 pairs IMD scores: 3/3,5/5,7/7,8/9, 1 = more deprived, 10 = less deprived) and then randomised into either intervention or control.

Following a study induction and CME (continuing medical education) session by the study team, in both arms GPs opportunistically approached any eligible women attending clinic with concerns about a family history of breast cancer or with breast symptoms or at routine health checks. This is in line with current NICE guideline recommendations. The GP provided the study information pack including baseline outcome questionnaire. In the intervention arm the pack included family history questionnaire. Intervention practices also recruited participants systematically. This comprised a database search to identify eligible patients in the intervention practices to recruit by mailout of study information packs.

Intervention Practices:

After consent, participating women in the intervention arm completed the Family History Questionnaire (FHQ) and baseline outcome questionnaires (latter comprising: Spielberger State-Trait Anxiety Inventory, Lerman’s Breast Cancer Worry Scale, SF-6D, and Positive And Negative Affect Scale) and returned these questionnaires to the research assistant at the University of Nottingham, who forwarded the FHQ to the practice after entering the data into full (secondary care) FaHRAS software. Nominated clerical staffs at GP surgery were trained to enter information from the FHQ questionnaires into the online primary care abridged version of FaHRAS tool (GP-FAHRAS). The risk assessment and care pathway advice generated by GP-FaHRAS was given to GPs. In line with NICE guidelines, participants found to be at average risk of breast cancer (<17% lifetime risk of breast cancer) were posted a letter with reassuring risk information and a breast awareness leaflet. Participants at moderate (17- 29%) or high risk (30%+ lifetime risk of breast cancer) were posted a letter informing them of their increased risk status and were invited to discuss their risk of breast cancer and management with their GP. Also, participants at average risk of breast cancer, who were concerned about the risk information sent to them, were seen at their general practice.

Control Practices:

GPs provided their usual care in terms of familial breast cancer risk assessment and gave the same invitation pack (without FHQ) to women who attended with concerns about breast symptoms or a family history of breast cancer or other heath checks where a family history of breast cancer is collected (e.g. contraception. After the study period ended, participants recruited in the control practices were offered to complete a FHQ and have the assessment run on full (secondary care) FaHRAS software.


Computer records-based outcome measure were extracted at baseline and up to 8 months after last patient recruited. Self-reported outcomes measures were collected at baseline (in study pack) and by postal questionnaire at 2 weeks and 6 months after participants in the intervention arm had received their risk result letter.

Data analysis:

Quantitative descriptive analysis was completed including recruitment rates, retention rates, risk identification rates, assessment of appropriateness of referrals and frequency of responses in outcome questionnaire. The latter including identifying proportion of missing items

Results against objectives:

The study took place in eight GP practices in Derbyshire recruiting 1127 women through mail out and 20 opportunistically (10 control arm, 10 intervention arm). Telephone interview were conducted after the intervention period had ended, the participants were; 5 Administrative staff (1 control 4 intervention), 6 GPs (1 control 5 intervention and 23 patients).

Primary Objective: Feasibility of Intervention

Recruitment rate: 1147 total

Intervention arm: 1137 (1127 postal; 10 opportunistically) Control arm: 10 (all opportunistically)

The recruitment for mail out in intervention arm was 16.07% of eligible women (1127/7012). The opportunistic recruitment was based on estimated number of study packs handed out:

  • 12% (10/82) in intervention arm
  • 99% (10/91) in control arm

Retention rate (defined as return of outcome questionnaire):

Intervention arm:

Baseline: 95.25% (1083)

Returned questionnaire at 2 weeks:     81% (921)

Returned questionnaire at 6 months: 73.5%% (836)

 Control arm: Baseline: 90% (9)

Returned questionnaire at 2 weeks:     80% (8)

Returned questionnaire at 6 months:  50% (5)

Completion rate in practice

FAHRAS risk assessment run by general practice on 100% (1137 intervention) of patients. The FHQs had already been screened by the research team and any queries had already been resolved by the research team contacting the patient prior to sending to the GP. A total of 129 queries arose, these are categorised below; Signature required on consent form 54 (41.86%), genetic testing confirmation 34 (26.36%), clarification of relative diagnosis 27 (20.93%) and Incomplete FHQ 14 (10.85%).

Feasibility of outcome measure assessment

  •  FaHRAS Output

Intervention arm:

Average Risk (Population risk 63.94% (727) & Near population risk 27.9% (281)) This includes 5.8% (66) Discussed with Secondary Care and: confirmed average risk Further 11.4% (129) at increased risk. This includes 5.5% (63) Discussed with Secondary Care and confirmed increased risk

Control arm:

Average risk (Near population risk) 14.29% (1), and increased risk on FAHRAS assessment 85.71% (6).

  •  Risk assessment

Intervention arm:

population 88.65% (1008), higher than population 11.35% (129)

Control arm:

population 14.29% (1), higher than population 85.71% (6)


  • Accuracy of FAHRAS assessment

Agreement rate of 99.74% (1134/1137) between general practice assessment compared to RA completing full (secondary care) FaHRAS software. The 3 women with discrepancy are explained through subjectivity in interpretation of the self-reported family history which may suggest a better design for the family history questionnaire is required for future trials.

Adherence of Practitioners and Patients to recommended referral

11.3% (129) patients were recommended referral through FaHRAS assessment (intervention arm), 79.8% (103) were referred by their practitioner, of these referred women 69 (67.0%) attended secondary care specialist clinic.

  • Nature of the referrals

These are listed in Table 1. Just over half of women had referrals recommended based entirely on a breast cancer family history. Based on NICE referral pathway guideline, a further 63 of 105 patients recommended referral after discussion with specialist.

 Table 1. Referral Status Classification

 Total Study Referrals1



 Family History of Breast cancer



 Family History of Ovarian Cancer



 Family History of Breast and Ovarian Cancer



 Family History of Prostate Cancer



 Family History of Other cancers



 Referral instructed by FaHRAS



 Total Referrrals as instructed by Secondary Care



 Referrals instructed by SC due to classified as increased risk 2



 Referrals instructed by SC due to need to clarify information 



1Study Referrals based on intervention recruitment rate (n=1137) 

 2Includes moderate and high risk where participnts wold be eligible for extra screening



  • Appropriateness/outcome of referral

From the study 129 referrals were recommended, 122 were based on family history of breast and other related cancers.

The 56.6% (69) of women seen in specialist service: 85.51% (59) confirmed as higher than population risk, 14.49% (10) referred back to Primary Care at average risk. Of the 59, a further 9 women were referred back to primary care at increased risk but too young to start extra breast surveillance by mammography or MRI.

This is aggregated to: appropriate referrals 85.51% (59), inappropriate referrals 14.49% (10). This gives an attendance rate of 9.84 per 1000 eligible women, which equates to 1.42 per 1000 practice list size. This compares to 17 women referred from the 4 practices during the 12 months pre-intervention period. This gives an attendance rate of 2.42 per 1000 study eligible women or 0.35 per 1000 practice list size. Over the study period another 35 women, not participating in the study, were referred for familial breast cancer risk from intervention practices, giving an overall potential referral rate of 22.39 per 1000 eligible women

Of the 59 patients assessed as appropriate referrals in secondary care the surveillance recommended is displayed in Table 2.

Table 2. Recommended Surveillance for participants by age

Age Range Seen in Secondary Care Moderate Risk1 High Risk for surveillance2 High Risk for genetic Referral
30-39 10 5 4 1
40-49 27 15 12 0
50-59 16 6 10 0
60-69 6 2 4 0

1Yearly Mammography offered from 50-60 years, 2Yearly mammography Offered from 40-50 years

The patients in age group 30 – 39 would have been told to seek surveillance at 40 years.

The patients in age group 40-49 and assessed as moderate risk will have yearly mammography until 50.

The patients in age groups 40 – 49 and 50 – 59 assessed to be high risk will have yearly mammography until 60.

The patients in age group 60 – 69 within moderate and high risk will remain in national breast screening service.


After intervention period, study participants in control arm were also offered FAHRAS assessment. Seven (70%) of control patients took up assessment, 6 were identified at increased risk and offered referral. 3 took up referral.

Self-reported psychological outcome measures completion rate

Spielberger State Trait Anxiety: 96.32% (915) @ 2 weeks; 96.47% (792) @ 6 months

PANAS mood (positive): 97.79% (929) @ 2 weeks; 98.17% (806) @ 6 months

PANAS mood (negative): 97.89% (930) @ 2 weeks; 98.29% (807) @ 6 months

Lerman Breast Cancer Worry scale ; 98.95% (940) @ 2 weeks; 98.90% (812) @ 6 months

 Self-reported patient satisfaction outcome measures completion rate

Intent subscale of MISS 21 ; 11.79% (112) @ 2 weeks; 13.64% (112) @ 6 months The self-reported psychological measures completion rate includes the following

  1. Complete original questionnaires
  2. Whole reminder questionnaires sent due to non-response of the first questionnaire sent. Reminder questionnaires were sent if they were not received within 2 weeks of
  3. Partial questionnaires sent due to partial non-response of the first questionnaire

 One reminder questionnaire (one whole, or one partial) was sent to each relevant participant at each time point (baseline, 2 week, 6 months).


Secondary Objective: acceptability of intervention


All 8 general practices completed post-intervention data extraction. Considering outcomes derived from medical records within six months of the last study participant recruited at each practice, automated computer extraction performed well in identifying outcome measures: breast cancer diagnosis, referral activity, breast cancer genetic testing, MRI surveillance, chemoprevention prescribing, and contraindications. In the intervention practices manual review enhanced quality of the data extraction and picked up more instances of complete family history recording for breast cancer (+0.9%) and ovarian cancer (+0.1%), breast examinations (+1.5%), breast symptom consultations (+3.1%), breast self-exam advice (+1.2%), and mammography (+7.7%) (Table 3)

Table 3: Comparing the absolute difference in proportions for proposed trial outcome measures using automated extraction alone to automated extraction with manual review for 1,070 women which data from electronic health records were available.

Outcome variable


Automated Extraction only 

Automated Extraction with Manual Review Absolute Difference Conclusion

Breast Cancer Diagnosed

None Recorded (%)

Yes (%)


1,069 (99.9%)

1 (0.1%)


1,069 (99.9%)

1 (0.1%)





Automated extraction sufficient



None Recorded (%)

Breast Clinic (%)

Breast Surgery Advice (%)

Fast Track-Breast Cancer (%)


1,020 (95%)

42 (3.9%)

1 (0.1%)

7 (0.6%)


1020 (95.4%)

42 (3.9%)

1 (0.1%)

7 (0.6%)







Automated extraction sufficient

Family History of Breast Cancer

None Recorded (%)

Incomplete Family History (%)

Complete Family History (%)1



1,055 (98.4%)

17 (1.6%)

0 (0%)



1,036 (96.8%)

24 (2.3%)

10 (0.9%)








Requires manual review + family history questionnaire

Family History of Ovarian Cancer

None Recorded (%)

Incomplete Family History (%)

Complete Family History (%)



1,069 (99.9%)

1 (0.1%)

0 (0%)



1,066 (99.6)

3 (0.3%)

1 (0.1%)








Requires manual review + family history questionnaire

Breast Examination By Clinician

None Recorded




1,063 (99.3%)

3 (0.3%)



1,048 (97.9%)

22 (2.1%)







Requires manual review

Breast Symptom Consultation

None Recorded



1,067 (99.7%)

3 (0.3%)


1,034 (96.6%)

36 (3.4%)





Requires manual review

Breast Self-Exam Advice Given

None Recorded



1,052 (98.3%)

18 (1.7%)


1,039 (97.1%)

31 (2.9%)





Requires manual review

Breast Cancer Genetic Testing2

None Recorded



1,070 (100%)

0 (0%)


1,070 (100%)

0 (0%)





Automated extraction sufficient

Mammographic Surveillance

None Recorded



1,004 (93.8%)

66 (6.2%)


921 (86.1%)

149 (13.9%)





Requires manual review

MRI Surveillance

None Recorded



1,070 (100%)

0 (0%)


1,070 (100%)

0 (0%)





Automated extraction sufficient

Chemoprevention Prescribing3

None Recorded



1,069 (99.9%)

1 (0.1%)


1,069 (99.9%)

1 (0.1%)





Automated extraction sufficient


None Recorded



1,068 (99.8%)

2 (0.2%)


1,068 (99.8%)

2 (0.2%)





Automated extraction sufficient

1 Complete family history is defined when age and degree of relation for patient is documented


3 Tamoxifen, Rolaxifene

4 Deep vein thrombosis, Endometrial cancer

Nested qualitative study

The aim of the nested qualitative study was to explore primary care staff and patient experiences of a new intervention to improving identification of familial breast cancer in primary care. It also aimed to identify ways in which to overcome barriers to recruitment, assessment, and management of familial risk in primary care in the UK to inform future exploratory trial.


Patient participants were identified from lists of women who agreed to be interviewed on joining linked exploratory feasibility trial. The latter recruited women from eight practices in Derbyshire. Purposive sampling was used to obtain a sample of participants with a broad range of characteristics including age, ethnicity, social deprivation, and degree of familial risk. Further sampling was supplemented with manual searches of patient electronic medical records within GP practices and a specialist service in Derbyshire to identify women referred to secondary care based on their family history.

Audio-recorded semi-structured interviews were conducted between January and July 2015. They were arranged at a location and time convenient to participants. Each transcript was read several times to increase familiarity with each participant’s account. Initial codes (thoughts, ideas) were identified in each of the transcripts and were collated with quotations used to support/describe each code using NVivo software. The relationships between codes were identified and led to codes being combine to form broad themes, which led to further changes and refinement to represent a coherent narrative of the participant’s experiences. Initial coding schemes on transcripts during data collection were used to guide subsequent interviews.

Results: mapped to both objectives

Sixteen GP staff consented to a semi-structured interview. Nine GP staff (5GPs, 4 administrator) were recruited from the intervention practices. All intervention staff participated in a one-to-one interview with the exception of 1 interview (GP) conducted over the telephone. Three GP staff (1 GP, 1 practice manager, 1 nurse auxiliary) were recruited from control practices. Two interviews were conducted via telephone with the other conducted one-to-one interview (nurse auxiliary).

Twenty patient participants took part in telephone interview and three participating in a one-to-one interviews, which convened at either a local community health centre (n=2) and their registered practice (n=1). All patient participants identified themselves as White British and all, except one, spoke English as their first language.

Key Themes from the Data:


The following three overarching themes emerged from the interview data with GP staff:

  • challenges to identifying and interpreting a family history,

GPs highlighted that in usual clinical practice that there were few opportunities to take a family history of breast cancer. They identified that a family history would usually be taken, in line with NICE familial breast cancer recommendations, at specific clinic appointments, such as new patient checks, contraception prescriptions or reviews, and when a patient presents with breast concerns or symptoms. GP expressed concern that, within a 10 minute consultation, it is not feasible to collect a full family history from patients and have an in-depth discussion of the information. Similarly due to the time restraints in consultation, GPs have limited opportunity to assess whether any further action is required once they have obtained a family history from patients. GPs, whilst demonstrating understanding of risk factors, still lacked confidence in assessing patients’ lifetime risk of breast cancer in clinic

  • Acceptability of Practice-Based Decision Support for Breast Cancer risk assessment,

Patient participants perceived having a familial risk assessment performed was beneficial. They did not perceive the assessment led to any distress or a burden on their time. Women found completing the family history questionnaire to be easy and straightforward where they had minimal family history of cancer and were happy to liaise with members of their family. However, those with a more extensive family history of breast cancer found the FHQ to be a little more difficult either because relatives had died or were no longer in contact, particularly for the paternal side of the family. Once completing and returning their documentation, patients participants who were found to be at average risk were not worry about the outcome of their results. Women identified as being at increased risk had anticipated this and there was some anxiety before receiving their results.

Administrative staff perceived the decisional support software as simple and straightforward to use and were able to utilise the output of the software to produce documents needed for both the patients and GPs. However, if patients reported additional health information on their questionnaires, administrative staff were unsure how to manage this information. Although administrative staff perceived the decisional support software as simple and straightforward to use, if patients reported additional health information on their questionnaires, administrative staff were unsure how to manage this information. GPs and administrative staff described breast awareness information sheets, provided to patients at an average lifetime risk of breast cancer, were appropriate.

  • Challenges of proactive identification of risk in Practice

GPs expressed concern that a considerable amount of time was taken to screen large lists of eligible patients. The inclusion criteria was broad and, thus, clinicians had to scan patient notes to identify patients who could be approached and those who should be excluded. It was suggested that patient lists be shared between all GPs involved in the trial or that GPs screen their own patients as they would be more familiar with these patients

Whilst administrative staff expressed concerns over the time taken to process the family history questionnaires. Administrative staff made several recommendations that could be employed into a larger trial. These included having protected time during the day and have at least 2 administrators involved in processing the FHQs. Some administrators mentioned having experienced administrators involved would make the process easier, but others perceived that the FHQs could be processed by receptionists. Administrative staff made several recommendations that could be employed into a larger trial. These included having protected time during the day and have at least 2 administrators involved in processing the FHQs. Some administrators mentioned having experienced administrators involved would make the process easier, but others perceived that the FHQs could be processed by receptionists. A number of patients were reported to have not attended their appointments to discuss their referral with their GP. Participants’ reasons for not attending their referral appointments included other commitments, such as work, which took priority.

In the intervention practices, GPs mentioned that they struggled to approach patients during clinic appointments to complete the family history questionnaire. This was due mostly to forgetfulness because of the demands of dealing with patients’ multiple complaints. GPs, whilst demonstrating understanding of breast cancer risk factors, still lacked confidence in assessing patients’ lifetime risk of breast cancer in the consultation. GPs were also asked to review the outcome questionnaire that patients complete at three time points (baseline, two-weeks after patients received their risk assessment, and 6-month follow-up). The questionnaire included items about general mood and health and cancer worry. GPs believed it would be beneficial to assess woman’s psychological well-being when having them undergo a familial risk assessment. GPs suggested some amendments to the questionnaire, which included offering a clearer explanation as to why they were being asked these questions and making the questionnaire more concise. General Practice staff working in deprived areas mentioned that some patients would have trouble reading and understanding the questionnaire. In general, patient participants were happy to complete self-report measures of physical and emotional well-being. They mentioned how responding to the mood items made them more aware of their feelings at that time. Other participants understood why items about breast cancer worry and general health were included, but could not see the relevance between the emotional items and breast cancer.


There was a good response to systematically inviting women for familial breast cancer assessment, despite 3 of the 4 intervention practices in deprived area. Response to opportunistic recruitment was more disappointing. Any follow-up study will need to consider approaches to improve recruitment and retention.

Considering assessment using FAHRAS decision support tool, GP administrative staff performed well. GPs highlighted that they lacked time and resources to complete assessment in current consultations. In a follow-up full scale trial the GP team suggested training more administrative staff and better explanation in self- completed outcome questionnaire for reason for each group of psychological questions. They also indicated that opportunistic recruitment may not be effective. Women participating in the study were generally positive about the assessment.

Plain English summary

The aim of this study was develop a better approach to ensure women at higher familial risk of breast cancer are referred to specialist, leading to screening for early diagnosis. Whilst those at average, who do not need referral, stay under their GPs’ care.

To achieve this a Family History Questionnaire was created and mailed out to appropriate women in 4 practices (intervention arm practices) to complete in their own time, with a consent form and a general health and breast cancer worry questionnaire. The information from the family history questionnaire was returned to the University of Nottingham research team and was entered onto a computer package called FaHRAS which identified the breast cancer risk of women based on their family history. In the study, assessment was then rerun by a member of the General Practice administrative staff using a simplified online version of the FAHRAS computer package specifically designed for primary care. The risk result was passed to the GP. In another 4 practices (control arm practices) women with breast cancer concerns or family history of cancer taken at routine health check, were recruited to study but not offered the risk assessment. This group described as “standard care”.

In the study we recruited patients in all 8 practices as they came to see their GPs. Only 20 women were identified (10 offered FAHRAS assessment; 10 standard care – these women were offered FAHRAS assessment after study period ended). In the 4 Intervention practices all 7012 appropriate women were also mailed out study packs and 16.07% recruited.

Of the 1137 women recruited in intervention arm practices (1127 recruited via mail out, 10 identified by GP), 75% completed a follow-up questionnaire at 2 weeks, and 66% at 6 months. The administrative staff were very good at entering the family history information, out of 1137 they only made 3 mistakes (99.74% accurate).

Of the 1137 patients assessed with FAHRAS, 88.65% (1008) were not at increased risk, and 11.35% (129) were at increased risk and recommended referral. Of these women 69 (52.49%) were seen in specialist services, 59 (85.51%) were confirmed by the specialist to be at increased risk, whilst the remaining 10 (14.49%) were not at increased risk and discharged back to be cared for by their GPs.

The study team interviewed nine GP staff (5 GPs, 4 administrator) and twenty patients who had had the FAHRAS assessment. The GP staff suggested, in any further study, training more administrative staff and better explanation in outcome questionnaire, completed by patients, of reason for questions asked. They also indicated that recruiting women, incidentally, during consultation may not be effective.


It looks possible to systematically identify women, in primary care, at increased risk of breast cancer. Due to workload demands, assessment of women incidentally, during GP consultations maybe difficult.


Published outputs

Oureshi N, Weng S,Tranter J, El-Kadiki A, Kai j, Feasibility of improving identification of familial hypercholesterolaemia in general practice: intervention development study. BMJ Open


2015 ESHG NQ presented poster ‘From National Guideline Recommendations to Familial Cancer Risk Assessment Decision Support in Primary Care: UK Experience’

2017 ESHG BD presented poster ‘Improving Appropriateness of Referrals for Familial Breast Cancer in Primary Care’

PPI event March 2018 – present findings and future work for Familial Breast Cancer Research

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

Public involvement

A number of patient representatives were identified from a secondary care trust and agreed to be involved in the study. These include women with personal experience of breast cancer or a family history of breast cancer Through the help of these women, we consolidated patient and public involvement which directly fed into both study design and information leaflets.

Involvement of patients and relevant advocate groups at all stages of our previous research has proved invaluable in helping the research team to further focus the study design, output and dissemination on the needs of the public and the benefits that can be delivered for the community.

Specifically, the PPI representatives contributed to the preparation of ethics applications, protocol, and informed the purposeful sampling and interview schedules for the study. They also suggested improvements for future trials such as a creating a glossary of terms for patients with the Participant Information Sheet. By forging such links we have been able to involve our PPIs in future planned and related studies and will continue to benefit from their contribution and feedback in future study designs.

Collaboration also took place with Breast Cancer Now who provided the study with relevant documentation to send to the participating patients with their risk result; Risk Factor Leaflet, Touch Look Check Guide and advice on keeping their family history up to date with their GP


  • Initial evidence has been presented at All party parliamentary committee of breast and ovarian cancer
  • An implementation project with the Academic Health Science Network, FaHRAS and Division of Primary Care, University of Nottingham is currently being implemented in 4 CCG areas across England to offer the risk assessment software in general
  • The research team will continue to inform and contribute to NICE guidance for Breast Cancer Care and early prevention
  • By completion of the study, as a result of identifying increased familial breast cancer risk, a woman has been identified with breast cancer at a very early stage and accepted curative bilateral mastectomy

PPI representatives suggested 2 further impacts:

  • Empowers the participant with the choice to manage their own risk: if patient chooses not to take up the referral it is not necessarily a negative outcome
  • Increase awareness by General Practitioners of the importance of taking a family history


This project was funded by the National Institute for Health Research School for Primary Care Research (project number 206)

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.