Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery. A Multicentre, Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,200
- 试验地点
- 3
- 主要终点
- Avoidance of mastectomy
研究概览
简要总结
The study aspires to provide outcomes on surgery, quality of life and time-to-event outcomes following the development and validation of a standardised surgical assessment tool in a shared decision-making framework for patients with pre-invasive or invasive breast cancer with breast conservation.
详细描述
Oncoplastic breast-conserving surgery (OPBCS) has gained increasing popularity over the last years and tends to be considered the standard of care in surgical practice. OPBCS allows for the resection of larger volumes and tumors with acceptable cosmesis, by incorporating different techniques that have evolved mainly from mastopexy, mammoplasty, and breast reduction or volume replacement techniques, such as perforator flap reconstruction.
However, no randomized controlled trial data on indications, methods, decision-making and outcomes are available, and present practice is largely based on evidence from cohort data derived from single- or multi-institutional series. Along with that, the fact that surgical decision-making in OPBCS is highly individualized renders any effort for standardization of these operations highly challenging and controversial. This is a multifactorial phenomenon, owing to anatomic differences such as breast volume, breast shape, lesion volume, localization, ptosis, body mass index (BMI) but also patient preference and availability of surgical techniques. Efforts for standardization of techniques based on tumor location, breast size, and ptosis have been made, but they do not address the principle of tailored treatment and do not cover all clinical scenarios.
On the other hand, breast-conserving surgery (BCS) followed by whole breast irradiation (WBI) yields comparable to better outcomes compared with mastectomy without WBI in terms of survival, but much better in terms of quality of life (QoL) and patient-reported outcomes and measures (PROMS), even when compared to the reconstructed breast. At the same time, OPBCS seems to yield superior cosmesis and patient satisfaction compared to traditional wide local excisions (WLE), but it is unclear whether this comes at the cost of increased morbidity or unnecessary revisionary procedures, with an impact on the delivery of systemic treatment, QoL and health economy. In addition, patient preference is a factor that precludes randomization to the method of operation in the traditional meaning, as it would not be ethical to randomize surgery that may be unnecessarily extensive or oncologically dubious. Moreover, surgeon and patient preferences and expectations may involve bias which is hard to define and a non-randomized study on the subject of WLE vs OPBCS could inevitably be unclear in how to address this inherent flaw.
PROMS such as QoL and cosmesis are even more important in the case of benign lesions that need to be operated on. This has to do with the fact that no compromises need to be made for the sake of a radical breast cancer operation as well as that benign breast surgery is more common in women of younger age. There, despite the instinctive assessment that a well-placed incision should have better outcomes, there is a complete lack of high-quality data on the matter.
At the same time, the decision-making process of the choice of surgical technique is a phenomenon poorly investigated; surgeons tend to offer the techniques they are most comfortable with and offer therapy per patient preference largely dependent on the health setting. This may account for the lack of consistency in identifying factors related to re-excision, postoperative complications, and PROMS. In this procedure, patient preference has shown to vary depending on surgical consultation, not only on the choice not to undergo mastectomy but also on the extent of BCS. Another fact that needs to be taken into account is that, despite that several classification systems and algorithms have been proposed, everyday clinical practice represents more of a continuum. On the other hand, "standard surgical assessment" performed by breast surgeons is likely to reflect personal preferences, techniques one may be most comfortable with as well as variances in healthcare provision.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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 aged above 18 years.
- •Signed and dated written informed consent before the start of specific protocol procedures; oral consent for the participants of the quality control retrospective cohort study before accepting to partake a telephone interview.
- •Patients with invasive breast cancer (IBC) or ductal cancer in situ (DCIS) or unclear lesions mandating surgical excision or benign lesions amenable for surgical resection with BCS.
- •ECOG performance status 0-
- •Exclusion Criteria
- •Life expectancy of less than 6 months
- •Non candidate for breast conservation
- •Inability to understand given information and give informed consent or undergo study procedures
排除标准
- 未提供
结局指标
主要结局
Avoidance of mastectomy
时间窗: 3 months
Percenteage of patients not amenable to standard wide local excision following a standardized assessment, that are operated with oncoplastic breast conservation resulting in negative margins and avoid mastectomy.
Re-excision rates
时间窗: 3 months
Percenteage of patients not amenable to standard wide local excision following a standardized assessment, that undergo breast conservation, but require re-excision of margins without conversion to mastectomy as a final result.
Patient reported outcomes, BreastQ module for Satisfaction with Breasts
时间窗: Baseline, postoperative (6, 12, 24 months)
The BREAST-Q questionnaire is developed especially for breast cancer patients undergoing breast surgery. Independent modules are available for the different surgical interventions (e.g., mastectomy, reconstruction, augmentation). The BREAST-Q questionnaire has been validated and serves as of a standardized measurement instrument. The Satisfaction with Breasts module is summarized in a score ranging from 0 to 100, with higher scores denoting higher satisfaction
Patient reported outcomes, BreastQ module for Physical Wellbeing: Chest
时间窗: Baseline, postoperative (6, 12, 24 months)
The BREAST-Q questionnaire is developed especially for breast cancer patients undergoing breast surgery. Independent modules are available for the different surgical interventions (e.g., mastectomy, reconstruction, augmentation). The BREAST-Q questionnaire has been validated and serves as of a standardized measurement instrument. The Physical Wellbeing: Chest module is summarized in a score ranging from 0 to 100, with higher scores denoting higher wellbeing
Patient reported outcomes, European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30)
时间窗: Baseline, postoperative (6, 12, 24 months)
The European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Core Questionnaire (QLQ-C30) is a validated 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients. It assesses both quality of life domains and symptom domains in a scale score ranging from 0 to 100. For the quality of life domains, higher scores denote higher satisfaction or higher quality of life. For symptom scales, higher score denotes more severe symptoms. In the Summary Score of the Questionnaire, higher values denote higher quality of life
次要结局
- Profile of mastectomy candidates(Preoperative)
- Procedure-related costs(Postoperative)
- Operative time(At surgery)
- Postoperative Complications(6 weeks or up to 3 months if no other adjuvant oncologic treatment has been employed)
- Length of stay(Perioperative)
- Local Recurrence Free Survival(Up to 10 years)
- Locoregional Recurrence Free Survival(Up to 10 years)
- Overall Survival(Up to 10 years)
- Disease Free Survival(Up to 10 years)
- Breast Cancer Specific Survival(Up to 10 years)
研究者
Andreas Karakatsanis
Associate Professor, MD, PhD
Uppsala University
