Early detection of breast cancer risk in younger women Cancer
Conditions
Interventions
A cross-sectional cohort of 240 women, aged 30 to 49 years, will be recruited to undergo the Mi~Scan® breast density assessment. We anticipate recruiting approximately half (i.e. 120) of the women in
Sponsors
University of Manchester
Eligibility
Sex/Gender
Female
Age
30 Years to 49 Years
Inclusion criteria
Inclusion criteria: 1. Born biologically female 2. Aged 30-49 years at time of consent 3. Able to provide informed consent 4. Registered at participating GPs if recruited via primary care route
Exclusion criteria
Exclusion criteria: 1. Prior breast cancer diagnosis 2. Have had both breasts removed (a double mastectomy) 3. Are known to be currently pregnant (does not require pregnancy test) or breastfeeding 4. Are already under follow-up in breast cancer family history clinic or have a known mutation in a high-risk cancer gene such as BRCA1 or BRCA2 5. Have any implantable electronic devices (e.g., a cardiac pacemaker or implanted defibrillator) 6. Have non-removable nipple piercings or body modifications 7. Have had breast implants or augmentation surgery 8. Were not born biologically female 9. Have areas of broken skin on breast or armpit 10. Have conductive or electronic (tech) tattoos 11. Inability to understand written and verbal English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Acceptability of the Mi~Scan® device, measured using the standard Theoretical Framework for Acceptability questionnaire at baseline, immediately after participants have had the breast density scan | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety and performance of the Mi~Scan® device, measured using the following measures, all recorded at a single timepoint: 1. The reporting of adverse events: the number of adverse events and serious adverse events recorded through the study will be recorded and summarised using descriptive statistics. 2. The pain and discomfort domains of the questionnaire as the device should not cause any physical discomfort or pain. As such, the two questions on the 5-point Likert scale that imply there was some pain (“I found the scan to be a painful procedure” answers “strongly agree” and “agree”) or discomfort (“I found the scan to be a comfortable procedure” answers “Strongly disagree” and “disagree”) will be recorded as a percentage of the total responses in a descriptive analysis. 3. Focus group data: the focus groups with women who had the scan will explore the acceptability of general device performance and safety 4. Interview data: interviews with healthcare professionals who delivered the scans will explore the acceptability of general device performance and safety | — |
Countries
England, United Kingdom
Contacts
Public ContactMolly Parfett
Outcome results
None listed