Specialist Recommendation on FBC (Familial Breast Cancer) Chemoprevention Prescribing

Completed

• Conditions: Familial Breast Cancer
• Interventions: Other: Survey Administration

• Registration Number: NCT04058418
• Lead Sponsor: University of Nottingham

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.

Study Timeline

• Study First Submitted: 2019-06-12
• Study Start: 2019-07-22
• Study First Submitted QC: 2019-08-13
• Study First Posted: 2019-08-15
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-23
• Last Update Posted: 2023-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Familial breast cancer risk assessment services in England	Survey Administration	All familial breast cancer risk assessment services in England

Primary Outcome Measures

Name	Time	Method
Chemoprevention medication prescribing rates in primary care by area in England	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.
Proportion of specialist service that recommends chemoprevention prescribing by areas in England	2019	Proportion of specialist service that recommends chemoprevention prescribing by areas in England, measured using survey questionnaire

Trial Locations

Locations (1)

University of Nottingham; 🇬🇧 Nottingham, United Kingdom