Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05082740 |
| Other study ID # |
FH-Risk 2.0 Research Protocol |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2022 |
| Est. completion date |
September 29, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
University of Manchester |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
In the UK women with a strong family history of breast cancer are eligible for breast cancer
risk estimation via Family History Risk and Prevention Clinics (FHRPCs). Here breast cancer
risk is calculated using popular risk prediction models like the Tyrer-Cuzick, CanRisk or
Gail models. These models combine breast cancer risk factors to calculate a risk estimate for
women. Risk factors include, family history, hormonal and reproductive factors, and risk
factors related to health behaviours, for example, smoking, exercise and alcohol intake.
Recently, risk estimation for breast cancer has become more accurate with the inclusion of
mammographic density and Single Nucleotide Polymorphisms (SNPs) into popular risk prediction
models. The addition of these new risk factors could alter the risk estimates that women in
FHRPCs have been provided. How much these new risk factors alter a previously given risk
estimate is unknown. It is also unknown how women will react to a revised risk estimate,
especially if it changes their previous estimate and their access to preventive management
options.
This research aims to explore this gap in the literature.
Description:
Estimation of breast cancer risk is important since it enables selection of a high and
moderate risk population who benefit from more frequent breast screening and the introduction
of targeted measures to reduce risk such as lifestyle change, chemoprevention and risk
reducing surgery. Traditionally, risk is estimated by combining information concerning family
history and non-familial factors, such as age of menarche and first pregnancy. Subsequent
management is related to the degree of risk (high, moderate or average) according to NICE
guidelines. Members of the research team and others have added mammographic density (MD) and
breast cancer risk associated single nucleotide polymorphisms (SNPs) to risk models which
improves the accuracy of risk estimation but which may change the original given risk and
risk management given before the updated models became available.
The objective of this body of work is to quantify change in risk and risk management when MD
and SNPs are incorporated into two standard models (Tyrer-Cuzick v8 & BOADACEA V). A second
objective of the study is to determine the psychological effects of change of risk and
management.
This work will use participant data from the Family History Risk (FH-Risk) study to
recalculate risk. The FH-Risk study population consists of 954 women referred to the Family
History Risk and Prevention Clinic (FHRPC) between 2000 and 2012 who gave informed consent
for DNA testing and estimation of MD as part of the FH-Risk study which recruited between
2010 and 2012. Change in risk and management will be calculated by comparing given risk at
the time of clinic entry compared with re-estimated risk when MD and SNPs are added to the
risk models according to NICE guidelines. Risk will be estimated retrospectively at the time
of entry to the clinic and the time of latest follow up.
A sample of those who took part in the FH-Risk study who are still in the FHRPC for follow-up
or discharged (approx.954) will be given the opportunity to discuss their updated risk.
Following the risk update consultation a sample of women will be asked whether they would
like to take part in an interview to assess the psychological effects of the change, as well
as their views and perceptions of the change. These interviews will inform the development of
information materials for communicating recalculated risk. These materials will be appraised
via 'think aloud' interviews with women from the FH-Risk study who have received their
recalculated risk.
The results of this work are likely to inform the next iteration of NICE management
guidelines for Family History Clinics, as well as inform the creation of patient facing
information materials to aid patient - healthcare professional communication. The findings
will also be used to develop a questionnaire to be given to women who previously took part in
the FH-Risk study to assess the psychological impact of changed risk in a definitive study.
This body of work is split into 3 studies:
Study 1 - risk recalculation
Risk recalculation will be performed for all women who took part in the original FH-Risk
study, with all women (still under follow up at the FHRPC or discharged) given the
opportunity to attend a consultation to discuss their revised breast cancer risk estimate.
Study 2 - women's experiences of receiving a revised breast cancer risk estimate.
One to one semi-structured interviews will be conducting with women from study 1 to explore
their experiences of receiving a revised breast cancer risk estimate. Breast cancer risk
appraisals, the trustworthiness of the estimate, women's emotional responses will all be
considered in these interviews. Information and communication needs will also be explored.
Study 3 - a questionnaire study assessing for whether women's subjective risk appraisals are
inline with the revised risk estimate provided.
A questionnaire will be distributed to women in the study and they will be asked about their
subjective risk appraisals, their thoughts on whether risk has changed, their satisfaction
with the risk communicated and their cancer worry.
