Breast cancer Cancer
Conditions
Interventions
The CanRisk-GP research study is a pragmatic multicentre feasibility study of proactive multifactorial breast cancer risk assessment within general practice (GP), which will take place within 5 to 8 G
Sponsors
University of Cambridge
Eligibility
Sex/Gender
Female
Age
40 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1. Aged 40-49 years 2. Registered with a participating general practice 3. Capacity to consent 4. English speaker
Exclusion criteria
Exclusion criteria: 1. Personal history of breast or ovarian cancer 2. Known high-risk gene mutation 3. Previous diagnosis of metastatic cancer or entry on the palliative care register 4. Prior notification of dissent to research 5. Lack of capacity to consent 6. Non-English speaker
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Uptake of multifactorial breast cancer risk assessment, including the proportion of those invited who consent and the proportion of those invited who complete the breast cancer risk assessment, with or without the inclusion of the polygenic risk score. Measured from recruitment data and completion of MyCanRisk and return of saliva sampling kits for genetic analysis at baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Distribution of breast cancer risk measured using CanRisk risk score generated at baseline and following further clinical assessment where applicable 2. Identification of women at moderate and high risk of breast cancer, including the proportion of registered women aged 40-49 years at participating practices who are at moderate or high risk of breast cancer after assessment in secondary/tertiary care compared with the proportion of women aged 40-49 years at moderate or high risk of breast cancer after referral to secondary/tertiary care at non-participating practices across Cambridgeshire and Peterborough and compared with the proportion of registered women aged 40-49 years at participating practices in the 12 months prior to the study. Measured using data on referrals to secondary/tertiary care from across Cambridgeshire and Peterborough during the study and from participating practices for the 12 months before the study start. 3. Uptake of risk-reducing interventions measured using GP appointment, referral and outcome data collected at end of study 4. The amount of information collected through MyCanRisk measured using MyCanRisk completion at baseline 5. Psychological and behavioural impact of multifactorial breast cancer risk assessment, measured through participant questionnaires including measures of cancer worry (the Lerman cancer worry scale-R, the short-form of the STAI and the EQ-5D-5L) at baseline, 4 weeks, 3 months and 6 months 6. Acceptability of the pathway, including response rates and completion of questionnaires, measured through participant questionnaires incorporating elements of the theoretical framework of acceptability at baseline, 4 weeks, and 3 months and 6 months, healthcare professional questionnaires incorporating the NoMAD checklist at end of study, and participant and healthcare professional interviews throughout the study, and observation of GP appointment for women above population-level risk 7. Response rates and completion of quest | — |
Countries
England, United Kingdom
Contacts
Public ContactCambridge University Hospitals CanRisk-GP study team
Outcome results
None listed