At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Not specified by the sponsor
- How long the study runs
- Study runs about 28 months (dates as stated)
- About the drug or intervention
- Not specified by the sponsor
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called the PROM-S Study, looks at women having standard breast conserving surgery (sometimes called a lumpectomy) for breast cancer. It compares how women feel about their scars and their clinical results, depending on where the scar is placed on the breast. It is sponsored by The Leeds Teaching Hospitals NHS Trust.
Who can take part
- Women aged 18 or over
- Able to give written informed consent
- Have invasive breast cancer or ductal carcinoma in situ (DCIS, early-stage cancer inside the milk ducts) that can be treated with standard breast conserving surgery, including cancers in more than one place needing two wires or magseeds
- Able to understand and complete a questionnaire
- Scar placed over the cancer (radial, transverse, vertical or oblique) or a remote cut-away incision (at the side of the breast, around the nipple, in the crease under the breast, Benelli or hemi-batwing)
- Any tumour size, based on the clinical team's assessment
- Any status of the lymph nodes under the arm
- Cancer in both breasts is allowed
- Chemotherapy before surgery is allowed
Who may not be able to
- Men and transgender patients
- Patients having oncoplastic breast conserving surgery (such as wise pattern or vertical scar mastopexy incisions, or volume replacement chest wall perforator flap)
- Patients having a mastectomy, with or without immediate reconstruction
- Patients needing nipple removal (central wide local excision)
- Patients having surgery under local anaesthetic (awake)
- Women unable or unwilling to give informed consent
- Cases where the cancer is very close to, or involves, the skin and skin over the tumour must be removed
- Cancer that has come back in the same breast or nearby area
- Cancer that has spread to other parts of the body
- Surgery to remove atypical (unusual) or benign (non-cancer) breast lesions
- A phyllodes lesion (a rare breast tumour)
- Previous surgery on the same breast (any type)
What taking part involves
- • Standard breast conserving surgery (removal of the cancer with some surrounding tissue, keeping the breast)
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team; the data only mentions completing a questionnaire about how you feel about your results.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 100
- Started
- 2025-02-20
- Last checked
- 2025-07
Plain English Summary
What is this study?
- • Testing a new treatment for breast cancer - female
- • Clinical study - 100 participants
- • 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)
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with breast cancer - female
- • Female only
Where?
- • Leeds - St James's University Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
Advances in surgical techniques, has led to a growing importance on breast appearance (cosmesis). Presently, scar placement for standard breast conserving surgery (sBCS) can vary from either directly over the cancer or be in remote locations with the aim of hiding the scar in more aesthetically acceptable locations on the breast. A number of factors dictate the outcome of scar placement such as aesthetics, comorbidities, location of the cancer, etc. However, it is currently unclear whether the location of scar placement for sBCS affects patient reported outcomes in short- or long- term post-surgery as we do not have sufficient information from the patient's point of view of their experience and satisfaction. We will use a validated patient outcomes questionnaire for breast surgery (BREAST-Q) to compare patient satisfaction with scar placement (over the lesion vs. remote) for patients undergoing sBCS. We hope that the results will provide valuable additional information when future patients are counselled with regards to scar placement. The principle research objective is to assess the impact of scar placement location on patient reported and clinical outcomes utilising the BREAST-Q questionnaire in patients undergoing standard breast conserving surgery (sBCS). Secondary objectives include: * comparing aesthetic outcome (appearance) and functional outcome of standard breast conserving surgery based on scar placement using Patient Reported Outcome Measures (PROMs) from the patients' point of view. * comparing clinical outcomes between over the lesion vs. remote scar placement in patients undergoing standard breast conserving surgery * explore potential factors that influence the locations of scar placement for standard breast conserving surgery (surgeon / clinical factors). * explore the extent of patient involvement in decision-making process This is a single-centre, non-randomised observational study that aims to recruit a minimum of 75 participants. The surgery could be for invasive or non-invasive breast cancer, with or without axilla surgery. All patients will be invited to complete the BREAST-Q patient reported outcome questionnaire on four occasions. The four time points are: before surgery, 2 weeks after surgery and at 3 and 12 months after surgery.The BREAST-Q is a standardised and validated questionnaire that covers symptoms and issues such as physical, sexual and psychosocial well-being, satisfaction with breasts, the impact of radiotherapy and satisfaction with the treating medical team and the level of information provided. The patient will receive instructions for completing the questionnaires from the study team. These can be completed either in paper forms or electronically. Additionally, socio-demographic and routine clinical data collected as part of standard care (including but not limited to complications and other treatments required, such as radiotherapy) will be recorded.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
What the study is looking for
- ✓Female patients ≥18 years of age
- ✓Able to provide written agreement to take part
- ✓Invasive breast cancer or ductal carcinoma in situ (DCIS) suitable for sBCS (including multifocal cancers requiring...
- ✓Able to understand and complete the questionnaire
- ✓No restrictions on tumour size (decision on suitability for sBCS will be based on clinical assessment)
Who cannot take part
- ✗Male patients (BCS not proven as the usual treatment) or transgender
- ✗Patients undergoing oBCS (such as wise pattern, vertical scar mastopexy incision pattern or volume replacement chest...
- ✗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
See the full criteria
Where Is This Study? (1 UK site)
St James's University Hospital
Leeds LS9 7TF, United Kingdom
How to Get in Touch
Sue M Dr Hartup, PhD, RGN
Sponsor contactCONTACT
Baek Mr Kim, FRCS, MD, MA
Sponsor contactCONTACT