Prevention of breast cancer in clients at increased risk Cancer
Conditions
Interventions
The study is a single-site study to evaluate the novel Preventing Cancer with Medications (PCMed) Service (the intervention) situated at the Peter MacCallum Cancer Centre in Melbourne, Australia. This
the potential absolute risk reduction if risk-reducing medications are taken
and other benefits and side effects of the medication/s.
For clients who indicate a desire to start a risk-reducing medication a prescription is provided, and an appointment is booked in eight to ten
Sponsors
Peter MacCallum Cancer Centre
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Eligibility criteria for clients: 1. Female 2. Age between 20 and 70 years old 3. Residual lifetime breast cancer risk of at least 20% or a 10-year risk of at least 5%, or history of lobular carcinoma in situ (LCIS) or atypical hyperplasia, or previous thoracic irradiation 4. Does not require germline genetic testing to further clarify the risk 5. Does not carry a pathogenic variant in a high-risk breast cancer predisposition gene and is not an untested 1st-degree relative for carriers 6. No history of invasive breast cancer or ductal carcinoma in situ (DCIS) 7. No history of bilateral mastectomy 8. No prior or current use of breast cancer prevention medications Eligibility for clinicians: Clinicians working in clinics from which eligible clients could be referred
Exclusion criteria
Exclusion criteria: Not meeting the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Use of risk-reducing medications measured using data documented in the medical records or self-reported at 12 months after a Risk Management Consultation | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 25/10/2024: The following secondary outcome measures are assessed using data recorded in medical and study records and by self-reporting at the end of the study unless specified: 1. Adoption of the PCMed Service measured using the attendance by women at the PCMed Service within 6 months following a documented discussion on the PCMed Service at the relevant catchment clinic. 2. Use of risk-reducing medications by clients measured by self-report at 6-months after the PCMed Service consultation where a decision was made. 3. Reason for not using risk-reducing medications measured by self-report at 6 months after the PCMed Service consultation where a decision was made. 4. Acceptability of the PCMed Service by clients measured using a brief questionnaire based on the theoretical framework of acceptability at 2 to 3 weeks following the PCMed Service consultation where a decision was made, and a telephone interview following the last planned PCMed Service consultation. 5. Acceptability of the PCMed Service by clinicians measured using a questionnaire and a telephone interview (based on the Theoretical Framework of Acceptability) at the end of the study recruitment period. 6. Feasibility and fidelity of the PCMed service intervention will be assessed using the following variables at the end of the study: 6.1. The number of consultations conducted by telehealth vs face-to-face vs telephone as recorded in the medical record at the time of the consultation. 6.2. Attending clinician type for each appointment (nurse practitioner and/or medical oncologist) as recorded in the medical record at the time of the consultation. 6.3. Duration of every consultation as measured using a stopwatch and recorded at the time of each consultation. 6.4. Number of consultations required before a prescription is written measured by the number of consultations a client has attended at the time a prescription is written for risk-reducing medications, or a | — |
Countries
Australia
Contacts
Public ContactKelly-Anne;Katrina Phillips;West
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Outcome results
None listed