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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
St James's University Hospital
RECRUITING
Leeds
Contact Information
Primary
Sue M Dr Hartup, PhD, RGN
s.hartup@nhs.net
+44 0113 2068628
Backup
Baek Mr Kim, FRCS, MD, MA
b.kim@nhs.net
+44 0113 2068628
Time Frame
Start Date: 2025-02-20
Estimated Completion Date: 2027-06
Participants
Target number of participants: 100
Related Therapeutic Areas
Sponsors
Leads: The Leeds Teaching Hospitals NHS Trust

This content was sourced from clinicaltrials.gov