Comparison of Patient Reported and Clinical Outcome Measures Based on Scar Placement in Patients Undergoing Breast Conserving Surgery (PROM-S Study)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The BREAST-Q - Breast Conserving Therapy Module
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
The BREAST-Q - Breast Conserving Therapy Module
时间窗: 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.
次要结局
未报告次要终点