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. 2018 Apr 23;18(1):456.
doi: 10.1186/s12885-018-4368-8.

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

Coriene J L M Catsman  1 , Martinus A Beek  2 , Adri C Voogd  3   4 , Paul G H Mulder  2 , Ernest J T Luiten  2
Affiliations

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

Coriene J L M Catsman et al. BMC Cancer. .

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.

Keywords: Breast cancer; Breast conserving surgery; Cosmetic result; Oncoplastic surgery; Patient reported outcomes; Quality of life.

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Conflict of interest statement

Ethics approval and consent to participate

The ethical requirements of this institution have been met; all patients signed informed consent before inclusion in this study. This study was approved by the Medical Ethical Commission (METC), Maxima Medical Centre, Veldhoven, The Netherlands (15.107) and is registered in the Dutch Trial Register: NTR5665 retrospectively registered, 02-25-2016.

URL: http://www.trialregister.nl/trialreg/admin/rctsearch.asp?Term=cosmam

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Example of BCCT.core software
See this image and copyright information in PMC

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