Breast Cancer - FemalePROM-SNCT07116642
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.
An observational study of Breast Cancer - Female and Surgery of Breast Cancer, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer - Female, Surgery of Breast Cancer
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Feb 2025to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients been treated with surgery at a single site in Leeds, UK
Who may be able to join
- 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)
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- Any axillary nodal staging status
- Bilateral cancers allowed
- Post neo-adjuvant chemotherapy (NACT) allowed
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
St James's University Hospital
Leeds, West Yorkshire, LS9 7TF
Sue Dr Hartup, PhD, RN, +44 0113 2068628, s.hartup@nhs.net
Baek Mr Kim, FRCS, MD, MA, b.kim@nhs.net
About this study
Official title: Comparison of Patient Reported and Clinical Outcome Measures Based on Scar Placement in Patients Undergoing Breast Conserving Surgery (PROM-S Study)
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Breast Cancer - Female, Surgery of Breast Cancer
- Keywords
- breast cancer, surgery, patient reported outcomes
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from enrolment to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2025
- Study start20 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer - FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sue Dr Hartup, PhD, RN, Principal investigator, Leeds Teaching Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116642
- Sponsor's protocol ID
- CO24/163189
- Acronym
- PROM-S
- Status last verified
- Jul 2025
- First submitted
- 6 Aug 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Reported and Clinical Outcome Measures Based on Scar Placement in Patients Undergoing Breast Conserving Surgery (PROM-S Study)
- ClinicalTrials.gov ID
- NCT07116642
- Acronym / sponsor ID
- PROM-S / CO24/163189
- Conditions
- Breast Cancer - Female, Surgery of Breast Cancer
- Keywords
- breast cancer, surgery, patient reported outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 11 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients been treated with surgery at a single site in Leeds, UK
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The BREAST-Q - Breast Conserving Therapy Module
Time frame: from enrolment to 12 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sue Dr Hartup, PhD, RN principal investigator
Leeds Teaching Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer - Female and Surgery of Breast Cancer, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sue M Dr Hartup, PhD, RGN (+44 0113 2068628, s.hartup@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The BREAST-Q - Breast Conserving Therapy Module (time frame: from enrolment to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2025.