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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.

Recruitingn/aAges 18 Years - anyFemaleThe Leeds Teaching Hospitals NHS Trust
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In plain words

What the trial is, and whether it could suit you

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 im

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Female patients โ‰ฅ18 years of age * Able to provide written informed consent * Invasive breast cancer or ductal carcinoma in situ (DCIS) suitable for sBCS (including multifocal cancers requiring x2 wires or magseeds) * Able to understand and complete the questionnaire Scar over the lesion defined as radial, transverse, vertical, oblique scar over the tumour lesion location in the breast Remote incisions defined as lateral perimeter/periareolar/infra-mammary fold/ benelli/hemi-batwing * No restrictions on tumour size (decision on suitability for sBCS will be based on clinical assessment) * Any axillary nodal staging status * Bilateral cancers allowed * Post neo-adjuvant chemotherapy (NACT) allowed Exclusion Criteria: * Male patients (BCS not proven as standard of care) or transgender * Patients undergoing oBCS (such as wise pattern, vertical scar mastopexy incision pattern or volume replacement chest wall perforator flap) * Patients undergoing mastectomy with or without immediate autologous or implant reconstruction * Patients requiring nipple excision (central wide local excision) * Patients undergoing wide local excision under local anaesthetic * Women not able or willing to give informed consent * Where close tumour proximity to skin or skin involvement necessitates skin excision over the tumour * Patients diagnosed with locoregional recurrence * Patients diagnosed with associated distant metastasis * Patients undergoing diagnostic excision surgery for atypical breast lesions or benign lesions * Patients diagnosed with phyllodes lesion * Patients who have had previous ipsilateral breast surgery (any type)
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What it tests

  • Not listed
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Where

1 site
St James's University Hospital
Leeds, United Kingdom
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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