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.

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

Inclusion Criteria:

* Female patients ≥18 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)

Conditions4

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