Clinical trial NCT04058418: Specialist Recommendation on FBC (Familial Breast Cancer) Chemoprevention Prescribing
Official title: Impact of Familial Cancer Specialist Recommendation on Chemoprevention Prescribing for Familial Breast Cancer (FBC) Risk in Primary Care: Short Survey and Interrupted Time Series Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Familial Breast Cancer
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2019-08-15
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: NHS familial cancer services and general practices in England

Brief summary: Some women are more likely to get breast cancer as it runs in their family, they are at risk of familial breast cancer. There are medications, called chemoprevention, which may lower their risk of developing breast cancer by a third. However chemoprevention can also cause serious side effects, like womb cancer and blood clots. This makes decision to start them difficult. Researchers found that not all women who can have these medications are on them.

The investigators want to ask familial breast cancer specialists whether they recommend general practitioners (GP) to prescribe chemoprevention, by sending them a short survey. These specialists look after women where breast cancer runs in the family. The specialists assess a women's chance of getting breast cancer and advice those with increased risk what can be done to prevent breast cancer.

The investigators will then look at whether specialist recommendation makes a difference to whether GPs prescribe chemoprevention medication. This will be done by linking the specialists' survey response to information on GP prescribing that the government regularly publishes. This may help the investigators understand why chemoprevention is not used as often as it potentially can be.

Detailed description: Phase I: Short survey of lead clinicians of familial cancer services, descriptive analysis of recommendations by areas of the country

Phase II: Prescribing data analysis (using OpenPrescribing) comprising:

1. t-test to compare the chemoprevention prescribing rate in general practices where chemoprevention is recommended versus not recommended;
2. interrupted times series analysis to assess the change in the chemoprevention prescribing after recommendation from specialist compared with changes occurring in practices where chemoprevention is not recommended and
3. panel regression across all practices, in order to distinguish the relative impacts of national versus local recommendation, and the change over time.

Eligibility criteria: Inclusion Criteria:

* Lead clinicians of NHS familial cancer services across England
* Standard general practices (classed as type 4 by NHS Digital, to exclude walk-in centres, prisons, care homes, etc.) with prescribing data for chemoprevention available on OpenPrescribing

Exclusion Criteria:

* General practices with less than 10 female patients aged 35 to 44 registered
* General practices which cannot be linked to any familial cancer service from survey responses

Primary outcomes:
measure: Proportion of specialist service that recommends chemoprevention prescribing by areas in England
timeFrame: 2019
measure: Chemoprevention medication prescribing rates in primary care by area in England
timeFrame: post specialist recommendation over 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: University of Nottingham
Study officials:
References:
citation: Curtis HJ, Walker AJ, Goldacre B. Impact of NICE guidance on tamoxifen prescribing in England 2011-2017: an interrupted time series analysis. Br J Cancer. 2018 May;118(9):1268-1275. doi: 10.1038/s41416-018-0065-2. Epub 2018 Apr 23.
citation: Qureshi N, O'Flynn N, Evans G. Dealing with family history of breast cancer: something new, something old. Br J Gen Pract. 2014 Jan;64(618):6-7. doi: 10.3399/bjgp14X676267. No abstract available.