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Quality of life and cosmetic result after breast saving surgery


- candidate number24030
- NTR NumberNTR5665
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-feb-2016
- Secondary IDsNL54888.015.15 MEC Number
- Public TitleQuality of life and cosmetic result after breast saving surgery
- Scientific TitleQuality of Life and satisfaction with cosmetic result in patients undergoing Breast Conserving Surgery
- ACRONYMCOSMAM TRIAL
- hypothesisPatients undergoing breast conserving surgery in combination with oncoplastic surgery are more satisfied with the cosmetic result and have a higher quality of life
- Healt Condition(s) or Problem(s) studiedBreast cancer, Breast conserving surgery, Quality of life, Cosmetic outcome
- Inclusion criteria- > 18 years
- Female
- Breast cancer eligible for BCS; either primarily of following neo-adjuvant systemic therapy
- Exclusion criteria- History of Breast cancer
- Incapacitated adults
- Not familiar with Dutch language
- Radiation therapy in the head/neck/axillary or breast region in the past
- Metastasis
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-jul-2015
- planned closingdate1-jul-2017
- Target number of participants300
- InterventionsBreast conserving surgery
Breast conserving surgery and oncoplastic surgery
- Primary outcomeThe aim of this trial is to assess the additional value of (different levels of) OPS in patients with breast cancer who are candidates for breast conserving surgery, with regard to quality of life and satisfaction with cosmetic outcome and objective measurements of the final cosmetic result versus patients undergoing standard breast conserving surgery.
- Secondary outcomeSecondly this trial will examine the value of different quality of life scoring systems in evaluating satisfaction with cosmetic results in patients undergoing breast conserving surgery.
- TimepointsT = 0 Pre-operative
T = 1 4 weeks after operation
T = 2 1 year after operation
- Trial web sitewww.cosmam.nl
- statusrecruitement status not public
- CONTACT FOR PUBLIC QUERIES Coriene J.L.M. Catsman
- CONTACT for SCIENTIFIC QUERIES Coriene J.L.M. Catsman
- Sponsor/Initiator Amphia Hospital Breda
- Funding
(Source(s) of Monetary or Material Support)
Amphia Hospital Breda
- PublicationsNone
- Brief summaryBackground: Treatment of breast cancer has drastically evolved and less aggressive surgical operation was constantly noted. The last decade a better overall cosmetic result in breast conserving surgery (BCS) became more desirably partly because of increasing survival in breast cancer patients and by preservation of body image and quality of life (QOL), next to its primary goal of complete resection of the tumour. Currently, approximately 30% of the patients treated with classic BCT are disappointed with the cosmetic result after adjuvant radiotherapy. The focus of BCT has now shifted toward recognizing the potentially unfavourable resection defect and reconstructing this defect in an attempt to prevent deformity.

Study design and aim: The COSMAM TRIAL is an observational prospective cohort study. The aim of this prospective cohort study is to investigate the difference in quality of life and satisfaction with cosmetic result in patients with breast cancer undergoing breast conserving therapy surgery versus patients undergoing breast conserving surgery with oncoplastic breast surgery stage I and II

Methods: All female patients, that are eighteen years or older, with pathology proven breast cancer eligible for BCS, who are referred to our outpatient clinic from, July 2015, will be evaluated for inclusion in this study. Before surgery and both one month and one year after surgery photographs of the breast will be taken to score cosmetic result both qualitative and quantitative by using an expert panel, the patient and its possible partner and BCCT.core software. At the same time points the patient will be asked to fill out a general questionnaire and QOL will be measured by using the BREAST-Q BCT questionnaire, EORTC-QLQ and EQ-5D-5L. Our team will collect diagnostics and treatment characteristics during treatment.
- Main changes (audit trail)
- RECORD25-feb-2016 - 20-mrt-2016


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