Overview
This prospective, single-centre, parallel-group randomised controlled trial evaluates the optimal sequencing of mammography views in women with a history of breast cancer undergoing surveillance mammography. Women treated with breast-conserving surgery within the previous five years will be randomised 1:1:1:1 to one of four mammography view sequencing groups.
The primary objective is to compare patient-reported pain and satisfaction across sequencing groups. Secondary objectives include comparison of image quality (PGMI scoring), compression force, and breast thickness.
A total of 400 participants will be enrolled at Beaumont Hospital Breast Care Centre over 2.5 years.
Description
Women with a history of breast cancer routinely undergo annual surveillance mammography following breast-conserving surgery and radiotherapy. Standard mammography includes mediolateral oblique (MLO) and craniocaudal (CC) views of each breast. However, there is limited evidence regarding whether the order in which these views are obtained affects patient experience or image quality.
This study randomises 400 women (1:1:1:1) to four different view sequencing protocols:
- Untreated MLO --- Treated MLO --- Untreated CC --- Treated CC
- Untreated CC --- Treated CC --- Untreated MLO --- Treated MLO
- Treated MLO --- Untreated MLO --- Treated CC --- Untreated CC
- Treated CC --- Untreated CC --- Treated MLO --- Untreated MLO
Pain is assessed using a visual analogue scale (VAS) before and after mammography. Patient satisfaction is measured using a post-procedure questionnaire. Image quality will be assessed retrospectively using PGMI scoring by two radiologists. Compression force and breast thickness will also be recorded.
The study uses an intention-to-treat analysis framework.
Eligibility
Inclusion Criteria:
Female patients aged 18 years or older History of breast cancer treated with breast-conserving surgery (wide local excision) Undergoing first annual surveillance mammogram following completion of surgery and radiotherapy Within five years of breast cancer treatment May have history of whole-breast or partial-breast radiotherapy May have history of axillary surgery Able and willing to provide informed consent
Exclusion Criteria:
Male patients Patients younger than 18 years History of mastectomy History of bilateral wide local excision Lack of capacity to provide informed consent More than five years since completion of breast cancer treatment