Quality of Life and satisfaction with cosmetic result in patients undergoing Breast Conserving Surgery

Quality of Life and satisfaction with cosmetic result in patients undergoing Breast Conserving Surgery - COSMAM TRIAL

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42536

Enrollment

300

Registered

2016-02-23

Start date

2016-07-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast conserving Surgery breastcancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - > 18 years - Female - Breast cancer eligible for breast conserving surgery

Exclusion criteria

Exclusion criteria: - History of Breast cancer - Not mentally competent - Insufficient knowledge of the Dutch language - Radiation therapy in the head/neck/axillary or breast region in the past - Metastasis

Design outcomes

Primary

Measure	Time frame
- What is the difference in QOL and satisfaction with cosmetic result in patients undergoing breast conserving surgery vs. oncoplastic surgery level I and II	—

Secondary

Measure	Time frame
- Which patients benefit from BCS with OPS? - Is there any difference between complications in patients undergoing BCS vs. BCS with OPS? - Is there any difference in LR en LRFS in patients undergoing BCT vs. BCS with OPS? - What is the cosmetic result in patients with multifocal tumours and tumours > 5 cm undergoing BCS with OPS - What is the quality of life in patients with multifocal tumours and tumours > 5 cm undergoing BCS with OPS? - What is the cosmetic result in patients undergoing BCT after re-resection BCT vs. BCT with OPS? - What is the and QOL in patients undergoing BCT after re-resection BCT vs. BCT with OPS? - What method should be used to score cosmetic result in patients undergoing BCT or BCT with OPS? - Which questionnaire should be used to score QOL in patients undergoing BCT or BCT with OPS?	—

Measure

Time frame

- Which patients benefit from BCS with OPS? - Is there any difference between complications in patients undergoing BCS vs. BCS with OPS? - Is there any difference in LR en LRFS in patients undergoing BCT vs. BCS with OPS? - What is the cosmetic result in patients with multifocal tumours and tumours > 5 cm undergoing BCS with OPS - What is the quality of life in patients with multifocal tumours and tumours > 5 cm undergoing BCS with OPS? - What is the cosmetic result in patients undergoing BCT after re-resection BCT vs. BCT with OPS? - What is the and QOL in patients undergoing BCT after re-resection BCT vs. BCT with OPS? - What method should be used to score cosmetic result in patients undergoing BCT or BCT with OPS? - Which questionnaire should be used to score QOL in patients undergoing BCT or BCT with OPS?

—

Countries

Netherlands

Outcome results