Dataset Information

The COSMAM TRIAL a prospective cohort study of quality of life and cosmetic outcome in patients undergoing breast conserving surgery.

ABSTRACT: BACKGROUND:Cosmetic result in breast cancer surgery is gaining increased interest. Currently, some 30-40% of the patients treated with breast conserving surgery (BCS) are dissatisfied with their final cosmetic result. In order to prevent disturbing breast deformity oncoplastic surgical techniques have been introduced. The extent of different levels of oncoplastic surgery incorporated in breast conserving surgery and its value with regard to cosmetic outcome, patient satisfaction and quality of life remains to be defined. The aim of this prospective cohort study is to investigate quality of life and satisfaction with cosmetic result in patients with breast cancer, undergoing standard lumpectomy versus level I or II oncoplastic breast conserving surgery. METHODS:Female breast cancer patients scheduled for BCS, from 18 years of age, referred to our outpatient clinic from July 2015 are asked to participate in this study. General, oncologic and treatment information will be collected. Patient satisfaction will be scored preceding surgery, and at 1 month and 1 year follow up. Photographs of the breast will be used to score cosmetic result both by the patient, an independent expert panel and BCCT.Core software. Quality of life will be measured by using the BREAST-Q BCT, EORTC-QLQ and EQ-5D-5 L questionnaires. DISCUSSION:The purpose of this prospective study is to determine the clinical value of different levels of oncoplastic techniques in breast conserving surgery, with regard to quality of life and cosmetic result. Analysis will be carried out by objective measurements of the final cosmetic result in comparison with standard breast conserving surgery. The results of this study will be used to development of a clinical decision model to guide the use oncoplastic surgery in future BCS. TRIAL REGISTRATION:Central Commission of Human Research (CCMO), The Netherlands: NL54888.015.15. Medical Ethical Commission (METC), Maxima Medical Centre, Veldhoven, The Netherlands: 15.107. Dutch Trial Register: NTR5665 , retrospectively registered, 02-25-2016.

SUBMITTER: Catsman CJLM

PROVIDER: S-EPMC5914027 | biostudies-literature | 2018 Apr

REPOSITORIES: biostudies-literature

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The COSMAM TRIAL a prospective cohort study of quality of life and cosmetic outcome in patients undergoing breast conserving surgery.

Catsman Coriene J L M CJLM Beek Martinus A MA Voogd Adri C AC Mulder Paul G H PGH Luiten Ernest J T EJT

BMC cancer 20180423 1

<h4>Background</h4>Cosmetic result in breast cancer surgery is gaining increased interest. Currently, some 30-40% of the patients treated with breast conserving surgery (BCS) are dissatisfied with their final cosmetic result. In order to prevent disturbing breast deformity oncoplastic surgical techniques have been introduced. The extent of different levels of oncoplastic surgery incorporated in breast conserving surgery and its value with regard to cosmetic outcome, patient satisfaction and qual ...[more]

PMID: 29688847

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Project description:BackgroundMastectomy currently constitutes a necessary surgical procedure in the oncologic setting and in the context of high risk. Prepectoral breast reconstruction (PBR) has been proposed as a surgical alternative to retropectoral techniques by providing less postoperative morbidity and a better cosmetic result. However, there is a lack of prospective studies that have evaluated its safety and patient-reported satisfaction.MethodsWe conducted a prospective cohort study to assess the safety, quality of life and cosmetic sequelae of PBR in women with breast cancer and high risk. The study's main objective is to assess the safety of PBR in terms of postsurgical complications and the feasibility of reconstruction (loss of implants). The secondary objectives are to evaluate oncologic safety (local relapses, residual glandular tissue) and to identify factors related to quality of life and cosmetic sequelae. The evaluation of residual tissue will be conducted by MRI 12 to 18 months after the surgery, and the quality-of-life assessment will be performed using the Breast-Q questionnaire. An initial patient evaluation will be conducted 12-18 months after the surgery, and a second evaluation will be performed at 5 years. The estimated sample size is 81 patients.DiscussionThe PreQ-20 study will analyze the impact of PBR on 3 separate measures: safety, quality of life and cosmetic sequelae. Unlike other studies that analyzed these three measures jointly for women with breast cancer and high risk, this study will individualize the results for these 2 patient groups. This differentiation is necessary from the methodological point of view, given that the 2 patient groups have separate clinical and emotional implications. The assessment of these groups will focus on the following aspects: postoperative complications, local relapses, evaluation of residual glandular tissue and incidence rate of primary tumors in the same, the cosmetic sequelae and the satisfaction and the quality-of-life assessment by the patients.Trial registrationClinicalTrials.gov: NCT04642508.

Project description:OBJECTIVES:To assess the health burden of breast hypertrophy and the comparative effectiveness of breast reduction surgery in improving health-related quality of life. DESIGN:Prospective cohort study. SETTING:A major public tertiary care hospital in Australia. PARTICIPANTS:Women with symptomatic breast hypertrophy who underwent breast reduction surgery were followed for 12 months. A comparison control cohort comprised women with breast hypertrophy who did not undergo surgery. INTERVENTIONS:Bilateral breast reduction surgery for women in the surgical cohort. MAIN OUTCOME MEASURES:The primary outcome measure was health-related quality of life measured preoperatively and at 3, 6 and 12 months postoperatively using the Short Form-36 (SF-36) questionnaire. Secondary outcome measures included post-surgical complications. RESULTS:209 patients in the surgical cohort completed questionnaires before and after surgery. 124 patients in the control hypertrophy cohort completed baseline and 12-month follow-up questionnaires. At baseline, both groups had significantly lower scores compared with population norms across all scales (p<0.001). In the surgical cohort significant improvements were seen across all eight SF-36 scales (p<0.001) following surgery. Within 3 months of surgery scores were equivalent to those of the normal population and this improvement was sustained at 12 months. SF-36 physical and mental component scores both significantly improved following surgery, with a mean change of 10.2 and 9.2 points, respectively (p<0.001). In contrast, SF-36 scores for breast hypertrophy controls remained at baseline across 12 months. The improvement in quality of life was independent of breast resection weight and body mass index. CONCLUSION:Breast reduction significantly improved quality of life in women with breast hypertrophy. This increase was most pronounced within 3?months of surgery and sustained at 12-month follow-up. This improvement in quality of life is comparable to other widely accepted surgical procedures. Furthermore, women benefit from surgery regardless of factors including body mass index and resection weight.

Dataset Information

The COSMAM TRIAL a prospective cohort study of quality of life and cosmetic outcome in patients undergoing breast conserving surgery.

Publications

The COSMAM TRIAL a prospective cohort study of quality of life and cosmetic outcome in patients undergoing breast conserving surgery.

Similar Datasets

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