Impact of 5-fraction Stereotactic Partial Breast Irradiation and Whole Breast Irradiation on Cosmetic Outcome and Patient-reported Outcomes in Early-stage Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Yonsei University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Change of patient reported psychosocial functioning score
- Last Updated
- 7 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pathologically confirmed invasive breast carcinoma or ductal carcinoma in situ (DCIS)
- •Women who underwent breast-conservating surgery and have a plan to undergoing partial or whole breast irradiation
- •Good performance status (ECOG 0-1)
Exclusion Criteria
- •Recurrent breast cancer
- •History of ipsilateral breast irradiation
- •Positive resection margin status after breast surgery
Outcomes
Primary Outcomes
Change of patient reported psychosocial functioning score
Time Frame: 2 year after radiotherapy (allowed to plus 8 weeks)
Patient reported psychosocial functioning measured in 7 point Likert scale
Change of patient reported patient treatment satisfaction score
Time Frame: 2 year after radiotherapy (allowed to plus 8 weeks)
Patient reported patient treatment satisfaction measured in 7 point Likert scale
Change of patient reported physical functioning score
Time Frame: 2 year after radiotherapy (allowed to plus 8 weeks)
Patient reported physical functioning measured in 7 point Likert scale
Change of patient reported body image score
Time Frame: 2 year after radiotherapy (allowed to plus 8 weeks)
Patient reported body image score measured in 7 point Likert scale
Change of breast cosmesis measures (excellent/good/poor)
Time Frame: 2 year after radiotherapy (allowed to plus 8 weeks)
breast cosmesis result is measures by BCCT.core (Breast Cancer Conservative Treatment cosmetic results) software
Change of breast-tissue fibrosis measures (gram)
Time Frame: 2 year after radiotherapy (allowed to plus 8 weeks)
breast-tissue fibrosis is measured by tissue compliance meter device.
Secondary Outcomes
- Incidence of Radiotherapy-related complications(2 year after radiotherapy (allowed to plus 8 weeks))