Specialist Recommendation on FBC (Familial Breast Cancer) Chemoprevention Prescribing

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.

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Key information

Conditions

Familial Breast Cancer Breast Cancer, Familial

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nottingham

Nottingham, United Kingdom

About this study

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:

t-test to compare the chemoprevention prescribing rate in general practices where chemoprevention is recommended versus not recommended;
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
panel regression across all practices, in order to distinguish the relative impacts of national versus local recommendation, and the change over time.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Survey Administration

Other

Completion of a short survey.

Primary outcomes

Proportion of specialist service that recommends chemoprevention prescribing by areas in England

Time frame: 2019

Proportion of specialist service that recommends chemoprevention prescribing by areas in England, measured using survey questionnaire
Chemoprevention medication prescribing rates in primary care by area in England

Time frame: post specialist recommendation over 24 months

2.1. The chemoprevention prescribing rate in general practices where chemoprevention is recommended versus not recommended. The rate will be measured as the number of average daily quantities (ADQs) of chemoprevention prescribed per 1000 registered female patients aged between 35 and 74 per practice. For our primary outcome we will measure only tamoxifen items, and assess other therapies used in chemoprevention in supplementary analyses.

2.2. The change in chemoprevention prescribing rate (described in outcome 2.1) in general practices after recommendation from local specialist, compared with changes occurring in practices where chemoprevention is not recommended.

2.3. The relative change in the chemoprevention prescribing rate (described in outcome 2.1) in general practice in response to local recommendation, compared with change occurring in response to national recommendation.

Sponsors and collaborators

Lead sponsor

University of Nottingham

Other

Collaborators

University of Oxford

Registry information

Official study 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

Acronym: FBC

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2019
First posted: Aug 15, 2019
Registry last updated: Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed