Specialist Recommendation on FBC (Familial Breast Cancer) Chemoprevention Prescribing

NCT04058418 | Completed

• 1 other identifier: 19049
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Familial Breast Cancer

Outcome Measures

Primary Outcomes (2)

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

  Proportion of specialist service that recommends chemoprevention prescribing by areas in England, measured using survey questionnaire

  2019

• Chemoprevention medication prescribing rates in primary care by area in England

  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.

  post specialist recommendation over 24 months

Study Arms (1)

Familial breast cancer risk assessment services in England

All familial breast cancer risk assessment services in England

Other: Survey Administration

Interventions

Survey Administration OTHER

Completion of a short survey.

Familial breast cancer risk assessment services in England

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

NHS familial cancer services and general practices in England

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nottingham: lead
• University of Oxford: collaborator

Study Sites (1)

University of Nottingham

Nottingham, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 29681615 BACKGROUND

• 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.

  PMID: 24567549 BACKGROUND

MeSH Terms

Conditions

Breast Cancer, Familial

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: August 15, 2019
• Study Start: July 22, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)