RecruitingNCT07116642

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.

Comparison of Patient Reported and Clinical Outcome Measures Based on Scar Placement in Patients Undergoing Breast Conserving Surgery (PROM-S Study)


Sponsor

The Leeds Teaching Hospitals NHS Trust

Enrollment

100 participants

Start Date

Feb 20, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares patient-reported outcomes (how patients feel about their scars and appearance) and clinical results based on whether the surgical scar from breast-conserving surgery (lumpectomy) is placed directly over the tumor or in a more discreet location on the breast. **You may be eligible if...** - You are a woman 18 or older - You have been diagnosed with invasive breast cancer or DCIS (early-stage breast cancer in the milk ducts) - You are scheduled for standard breast-conserving surgery (lumpectomy) - You are able to complete questionnaires **You may NOT be eligible if...** - You are male or transgender - You are having a mastectomy instead of lumpectomy - You require removal of the nipple area - You have cancer that has already spread to distant organs (metastatic) - You are having a local recurrence of breast cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

St James's University Hospital

Leeds, West Yorkshire, United Kingdom

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NCT07116642


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