Actively Recruiting
Comparing Patient Reported Outcomes and Clinical Outcomes Based on Different Scar Placement in Patients Undergoing Standard Breast Conserving Surgery for Breast Cancer: The PROM-S Study.
Led by The Leeds Teaching Hospitals NHS Trust · Updated on 2025-08-11
100
Participants Needed
1
Research Sites
118 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is for patients with breast cancer and the objective is to compare patient reported outcome measures (PROMs) based on scar placement in patients undergoing standard breast-conserving surgery (sBCS). BCS has become the standard of care for eligible patients with breast cancer (current UK national BCS rate is 60%). Scar placement for sBCS can be divided into two groups: those directly over the cancer, or those in remote locations (e.g. around the nipple, near the armpit, the lower part of the breast, where the breast and the chest meet etc.) with the aim of hiding the scar in more visually acceptable locations on the breast. Multiple factors determine where the scar is placed such as aesthetics, other health conditions, location of the cancer, etc. However, it is currently unclear whether the location of scar placement for sBCS affects patient reported outcomes. The growing importance on breast cosmesis has led to more attention from clinicians and patients with regards to the selection of surgical incision placement for sBCS. By using a validated questionnaire (BREAST-Q), we wish to assess if there is any difference in PROMs based on scar placement (over the lesion vs. remote) in patients undergoing sBCS. It is anticipated that the study results will help champion and guide care for future breast cancer patients, as well as providing an insight into how patient satisfaction may vary between different sBCS approaches. This questionnaire study will include consecutive patients undergoing sBCS at Leeds Teaching Hospitals NHS Trust. Participation in this non-randomised study will not impact on routine clinical care or decision making for the type of surgery planned or scar placement choice. Patients will be asked to complete the BREAST-Q questionnaire prior to surgery, after 2 weeks, as well as 3 and 12 months after surgery.
CONDITIONS
Official Title
Comparing Patient Reported Outcomes and Clinical Outcomes Based on Different Scar Placement in Patients Undergoing Standard Breast Conserving Surgery for Breast Cancer: The PROM-S Study.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients 65 18 years of age
- Able to provide written informed consent
- Invasive breast cancer or ductal carcinoma in situ (DCIS) suitable for standard breast conserving surgery (including multifocal cancers requiring x2 wires or magseeds)
- Able to understand and complete the questionnaire
- No restrictions on tumour size; suitability for surgery based on clinical assessment
- Any axillary nodal staging status
- Bilateral cancers allowed
- Post neo-adjuvant chemotherapy allowed
You will not qualify if you...
- Male patients or transgender individuals
- Patients undergoing oncoplastic breast conserving surgery such as wise pattern or volume replacement flap
- Patients undergoing mastectomy with or without reconstruction
- Patients requiring nipple excision
- Patients undergoing wide local excision under local anaesthetic
- Women not able or willing to give informed consent
- Tumour close to or involving skin requiring skin excision over the tumour
- Patients with locoregional recurrence of cancer
- Patients with distant metastasis
- Patients undergoing diagnostic excision for atypical or benign breast lesions
- Patients diagnosed with phyllodes lesion
- Patients who have had previous ipsilateral breast surgery of any type
AI-Screening
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Trial Site Locations
Total: 1 location
1
St James's University Hospital
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Actively Recruiting
Research Team
S
Sue M Dr Hartup, PhD, RGN
CONTACT
B
Baek Mr Kim, FRCS, MD, MA
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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