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.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorThe Leeds Teaching Hospitals NHS Trust

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

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.

Time frame
from enrolment to 12 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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