Optimal Mammography View Sequencing in Women With a History of Breast Cancer Undergoing Surveillance Mammography
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mammography View Sequencing.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Breast Cancer Recurrence, Post Treatment Surveillance. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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.
Detailed 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:
1. Untreated MLO --- Treated MLO --- Untreated CC --- Treated CC 2. Untreated CC --- Treated CC --- Untreated MLO --- Treated MLO 3. Treated MLO --- Untreated MLO --- Treated CC --- Untreated CC 4. 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.
Interventions
- Procedure Mammography View Sequencing
Standard surveillance mammography consisting of MLO and CC views of both treated and untreated breasts. Participants are randomised to one of four predefined sequences determining the order in which views are obtained. No additional imaging beyond standard of care is performed.
Primary outcome measures
- Change in Patient-Reported Pain Score During Mammography [Time frame: Immediately before and immediately after mammography (same study visit)]
- Patient Satisfaction Following Mammography [Time frame: Immediately after mammography (same study visit)]
Secondary outcome measures (5)
- Image Quality (PGMI Score) [Time frame: Following image acquisition (retrospective review after mammography during normal reporting timeframe institutionally)]
- Compression Force During Mammography [Time frame: During mammography (same study visit)]
- Breast Thickness During Mammography [Time frame: During mammography (same study visit)]
- Mean Glandular Radiation Dose [Time frame: During mammography (same study visit)]
- Duration of Mammography Procedure [Time frame: During mammography (same study visit)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Ireland · 1 center
- Beaumont RCSI Cancer Centre — Beaumont
Identifiers
NCT: NCT07443579 · 25-49