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.

NCT07116642 | Recruiting

• 1 other identifier: CO24/163189
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer - Female; Surgery of Breast Cancer

Keywords

breast cancer; surgery; patient reported outcomes

Outcome Measures

Primary Outcomes (1)

• The BREAST-Q - Breast Conserving Therapy Module

  The BREAST-Q is a validated PROM that has been developed for the use in a breast cancer population (Pusic et al. 2009). It can be used to assess the PROMs at pre-operative baseline and at multiple time points after surgery. In particular, the Breast Conserving Therapy Module is able to assess multiple domains including physical, sexual and psychosocial well-being, satisfaction with breasts, the impact of radiotherapy and satisfaction with the treating medical team and level of information provided (Klassen et al. 2020). The module uses an independent Rasch 'scales' with overarching themes of psychosocial and physical quality of life. The scores are converted to a Rasch scale 0-100 with higher scores meaning better satisfaction.

  from enrolment to 12 months

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients been treated with surgery at a single site in Leeds, UK

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Leeds Teaching Hospitals NHS Trust: lead

Study Sites (1)

St James's University Hospital

Leeds, West Yorkshire, LS9 7TF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sue Dr Hartup, PhD, RN

  Leeds Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sue M Dr Hartup, PhD, RGN

CONTACT

+44 0113 2068628; s.hartup@nhs.net

Baek Mr Kim, FRCS, MD, MA

CONTACT

+44 0113 2068628; b.kim@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 11, 2025
• Study Start: February 20, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: August 11, 2025

Record last verified: 2025-07

Locations

GB (1)