Proactive familial breast cancer risk assessment in primary care (Phase 2)
- Conditions
- Topic: Primary Care Research Network for EnglandSubtopic: Not AssignedDisease: All DiseasesCancerMalignant neoplasm of breast
- Registration Number
- ISRCTN16117197
- Lead Sponsor
- niversity of Nottingham (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2163
Eligibility for General Practice anonymised MIQUEST searches:
General Practices in Nottinghamshire who consent to undertake anonymised database searches.
Eligibility for Focus Group 1:
Women with a family history of breast cancer and no previous referral to specialist services, identified through newspaper adverts in Nottingham newspapers. Participants will be aged between 18 to 70 years.
Eligibility for Focus Group 2:
Women identified with a family history of breast cancer with previous experience of specialist services identified through the Royal Derby Hospital. Participants will be aged between 18 to 70 years.
Eligibility criteria for patient participants for the exploratory trial and nested qualitative study:
1. Women aged between 30 and 60 years
2. Registered with a participating GP practice
3. Able to complete the family history questionnaire in English (assistance from a household member is permitted)
4. Have NO history of breast or ovarian cancer
5. Must NOT have undergone a Familial Breast Cancer Assessment at specialist services in the previous 12 months
6. Must not have participated in the focus groups
Eligible health professionals for the exploratory trial are:
Consenting GPs (principals, salaried, registrars), nurses (including nurse practitioners/practice nurses) and administration staff at the study general practices in Derbyshire.
Eligible health professionals for the nested qualitative study are:
1. Consenting GPs (principals, salaried, registrars), nurses (including nurse practitioners/practice nurses) and
administration staff at the study general practices in Derbyshire.
2. Nominated lead GPs involved in providing the information or risk communication/consultation with patients from each intervention practice
3. Designated administrative staff entering the FHQ data into FaHRAS (risk assessment software); Target Gender: Male & Female; Upper Age Limit 70 no age limit or unit specified ; Lower Age Limit 18 no age limit or unit specified
Exclusion criteria for General Practice undertaking the anonymised MIQUEST searches:
General Practices who do not consent to undertake anonymised database searches.
Exclusion criteria for Focus Group 1:
Women who do not have a family history of breast cancer
Women who were referred to specialist services as part of their NHS care for breast cancer/suspected breast cancer.
Exclusion criteria for Focus Group 2:
Women who do not have a family history of breast cancer
Women who were not referred to specialist services, for familial breast cancer risk, at Royal Derby Hospital.
Exclusion criteria for patient participants for the exploratory trial and nested qualitative study:
1. Women outside the age range of 30-60 years
2. Not registered with a participating practice
3. Unable to provide written informed consent
4. Unable to complete the family history questionnaire in English
5. History of breast or ovarian cancer
Exclusion criteria for Focus Group 2:
Women who do not have a family history of breast cancer
Women who were not referred to specialist services, for familial breast cancer risk, at Royal Derby Hospital.
Exclusion criteria for patient participants for the exploratory trial and nested qualitative study:
1. Women outside the age range of 30-60 years
2. Not registered with a participating practice
3. Unable to provide written informed consent
4. Unable to complete the family history questionnaire in English
5. History of breast or ovarian cancer
6. Undergone a Familial Breast Cancer Assessment at specialist services in previous 12 months
7. Must not have participated in the focus groups.
8. Patients considered by the General Practitioners to be inappropriate to recruit due to psychosocial reasons.
Exclusion criteria for health professionals for the exploratory trial and nested qualitative study are:
GPs (principals, salaried, registrars), nurses (including nurse practitioners/practice nurses) and administration staff at general practices not participating in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proactively identify women at risk of familial breast cancer; Timepoint(s): Final analysis
- Secondary Outcome Measures
Name Time Method <br> 1. Optimise study design for a further trial; Timepoint(s): Final analysis will identify whether this study is successful in meeting its aims<br> 2. Streamlined referrals to specialist services; Timepoint(s): Measured through participant medical records at 6 month follow-up<br>