No registrations found.
Source
Brief title
Health condition
Breast Cancer
Lumpectomy
Breast saving therapy
Breast saving Surgery
Cosmetic result
Quality of life
Borstkanker
Kwaliteit van leven
Lumpectomie
Cosmetisch resultaat
Borstsparende therapie
Borstsparende chirurgie
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
The 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 outcome
Secondly 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.
Background summary
Background: 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.
Study objective
Patients undergoing breast conserving surgery in combination with oncoplastic surgery are more satisfied with the cosmetic result and have a higher quality of life
Study design
T = 0 Pre-operative
T = 1 4 weeks after operation
T = 2 1 year after operation
Intervention
Breast conserving surgery
Breast conserving surgery and oncoplastic surgery
Coriene J.L.M. Catsman
Molengracht 21
Breda 4818 CK
The Netherlands
076 - 595 1000
ccatsman@amphia.nl
Coriene J.L.M. Catsman
Molengracht 21
Breda 4818 CK
The Netherlands
076 - 595 1000
ccatsman@amphia.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL5544 |
NTR-old | NTR5665 |
CCMO | NL54888.015.15 |