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This study aim to investigate the effect of 5-fraction stereotactic partial breast irradiation and whole breast irradiation on patient-reported outcomes, cosmetic outcome, and breast tissue fibrosis in early-stage breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Partial Breast Irradiation (PBI) | Patients receiving 5-fraction stereotactic partial breast irradiation for breast cancer |
| |
| Whole Breast Irradiation (WBI) | Patients receiving whole breast irradiation for breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partial breast irradiation | Radiation | After breast- conservating surgery, all patients are allowed to receive partial breast irradiation or whole breast irradiation after surgery according to the international guidelines and physician's discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of patient reported psychosocial functioning score | Patient reported psychosocial functioning measured in 7 point Likert scale | Before radiotherapy (allowed to 8 weeks before radiotherapy) |
| Change of patient reported psychosocial functioning score | Patient reported psychosocial functioning measured in 7 point Likert scale | 2 year after radiotherapy (allowed to plus 8 weeks) |
| Change of patient reported patient treatment satisfaction score | Patient reported patient treatment satisfaction measured in 7 point Likert scale | Before radiotherapy (allowed to 8 weeks before radiotherapy) |
| Change of patient reported patient treatment satisfaction score | Patient reported patient treatment satisfaction measured in 7 point Likert scale | 2 year after radiotherapy (allowed to plus 8 weeks) |
| Change of patient reported physical functioning score | Patient reported physical functioning measured in 7 point Likert scale | Before radiotherapy (allowed to 8 weeks before radiotherapy) |
| Change of patient reported physical functioning score | Patient reported physical functioning measured in 7 point Likert scale | 2 year after radiotherapy (allowed to plus 8 weeks) |
| Change of patient reported body image score |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Radiotherapy-related complications | Investigators will check whether there are any kinds of radiotherapy-related complications after PBI or WBI. Any differences of complications according to the radiotherapy techniques will be examed. | Before radiotherapy (allowed to 8 weeks before radiotherapy) |
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Inclusion Criteria:
Exclusion Criteria:
Women undergoing radiotherapy after breast-conservating surgery at an academic center
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Women undergoing radiotherapy after breast-conservating surgery at an academic center
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Bae Kim, MD, PhD | Contact | 82-2228-8095 | ybkim3@yuhs.ac |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Recruiting | Seoul | Korea | 120-752 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37201757 | Derived | Byun HK, Chang JS, Kim H, Kim J, Han MC, Kim SY, Park RH, Kim CJ, Kim YB. Cosmetic Outcome and Toxicity After Stereotactic Accelerated Partial Breast Irradiation in Early Breast Cancer: A Prospective Observational Cohort Study. Int J Radiat Oncol Biol Phys. 2023 Nov 1;117(3):690-700. doi: 10.1016/j.ijrobp.2023.05.018. Epub 2023 May 17. |
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| Whole breast irradiation | Radiation | After breast- conservating surgery, all patients are allowed to receive partial breast irradiation or whole breast irradiation after surgery according to the international guidelines and physician's discretion. |
|
Patient reported body image score measured in 7 point Likert scale
| Before radiotherapy (allowed to 8 weeks before radiotherapy) |
| Change of patient reported body image score | Patient reported body image score measured in 7 point Likert scale | 2 year after radiotherapy (allowed to plus 8 weeks) |
| Change of breast cosmesis measures (excellent/good/poor) | breast cosmesis result is measures by BCCT.core (Breast Cancer Conservative Treatment cosmetic results) software - Investigators will whether there are any changes on patient-reported outcomes, cosmetic outcome, and breast tissue fibrosis after radiotherapy. Any differences of theses parameters according to the radiotherapy techniques (PBI vs. WBI) will be examed. | Before radiotherapy (allowed to 8 weeks before radiotherapy |
| Change of breast cosmesis measures (excellent/good/poor) | breast cosmesis result is measures by BCCT.core (Breast Cancer Conservative Treatment cosmetic results) software | 2 year after radiotherapy (allowed to plus 8 weeks) |
| Change of breast-tissue fibrosis measures (gram) | breast-tissue fibrosis is measured by tissue compliance meter device. | Before radiotherapy (allowed to 8 weeks before radiotherapy |
| Change of breast-tissue fibrosis measures (gram) | breast-tissue fibrosis is measured by tissue compliance meter device. | 2 year after radiotherapy (allowed to plus 8 weeks) |
| Incidence of Radiotherapy-related complications |
Investigators will check whether there are any kinds of radiotherapy-related complications after PBI or WBI. Any differences of complications according to the radiotherapy techniques will be examed. |
| 2 year after radiotherapy (allowed to plus 8 weeks) |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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