Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT04058418
Status:
COMPLETED
Last Update Posted:
2023-03-24
First Post:
2019-06-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Specialist Recommendation on FBC (Familial Breast Cancer) Chemoprevention Prescribing
Sponsor:
University of Nottingham
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FBC
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: