ISRCTN16117197Completed未知
Proactive familial breast cancer risk assessment in primary care: feasibility of an optimised intervention to improve identification and care of women at risk (Phase 2)
niversity of Nottingham (UK)0 sites2,163 target enrollmentStarted: December 20, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 2,163
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •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
- •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.
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