Specialist Recommendation on FBC (Familial Breast Cancer) Chemoprevention Prescribing

NCT ID: NCT04058418

Last Updated: 2023-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-22

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Familial Breast Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Familial breast cancer risk assessment services in England

All familial breast cancer risk assessment services in England

Survey Administration

Intervention Type OTHER

Completion of a short survey.

Interventions

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Survey Administration

Completion of a short survey.

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Oxford

OTHER

Sponsor Role collaborator

University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Nottingham

Nottingham, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 29681615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24567549 (View on PubMed)

Other Identifiers

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19049

Identifier Type: -

Identifier Source: org_study_id

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