SMC Radiation Oncology Breast Cancer Cohort Study

Study Overview
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Brief Summary
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The goal of this observational study is to learn about toxicities and cosmetic outcomes in breast cancer patients treated with hypofractionated radiotherapy. The main question it aims to answer are: Changes in breast skin Factors related to breast skin changes Patient-reported outcomes Cosmetic outcomes Participants will be assessed by multi-dimensional methods before and after radiotherapy: Photographs Fibrometer Questionnaires (BREAST-Q) CTCAE version 4.03 evaluated by treating physicians

Official Title
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Registry for Analysis of Impact of Radiation Dose to Skin on Cosmetic Outcome and Patient-reported Outcomes in Patients With Breast Cancer Treated With Radiation Therapy

Conditions
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Radiotherapy Side Effect

Intervention / Treatment
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* Radiation: Hypofractionated radiation therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer treated with curative surgery Exclusion Criteria: History of thoracic radiation therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: Hypofractionated radiation therapy|Both 3-week and 1-week hypofractioanted radiation therapy are allowed. (simultaneous or sequential tumor bed boost is allowed.) A 3-week regimen includes 42.4 Gy in 16 fractions. A 1-week regimen includes 26 Gy in 5 fractions or 28.5 Gy in 3 fractions, 30 Gy in 5 fractions.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of cosmesis from baseline | Evaluated by two blinded independent physicians based on photographs | After 2-3 weeks after the start of radiation therapy (During radiation therapy) | 
| Change of cosmesis from baseline | Evaluated by two blinded independent physicians based on photographs | 2-3 weeks after the completion of radiation therapy | 
| Change of cosmesis from baseline | Evaluated by two blinded independent physicians based on photographs | 6 months after radiation therapy | 
| Change of cosmesis from baseline | Evaluated by two blinded independent physicians based on photographs | 1 year after radiation therapy | 
| Change of cosmesis from baseline | Evaluated by two blinded independent physicians based on photographs | 2 year after radiation therapy | 
| Change of cosmesis from baseline | Evaluated by two blinded independent physicians based on photographs | 5 year after radiation therapy | 
| Change of fibrosis from baseline | Evaluated using fibrometer measuring both breast | After 2-3 weeks after the start of radiation therapy (During radiation therapy) | 
| Change of fibrosis from baseline | Evaluated using fibrometer measuring both breast | 2-3 weeks after the completion of radiation therapy | 
| Change of fibrosis from baseline | Evaluated using fibrometer measuring both breast | 6 months after radiation therapy | 
| Change of fibrosis from baseline | Evaluated using fibrometer measuring both breast | 1 year after radiation therapy | 
| Change of fibrosis from baseline | Evaluated using fibrometer measuring both breast | 2 year after radiation therapy | 
| Change of fibrosis from baseline | Evaluated using fibrometer measuring both breast | 5 year after radiation therapy | 
| Change of patient-reported outcome from baseline | BREAST-Q questionnaire is used to evaluate patient-reported outcome. | After 2-3 weeks after the start of radiation therapy (During radiation therapy) | 
| Change of patient-reported outcome from baseline | BREAST-Q questionnaire is used to evaluate patient-reported outcome. | 2-3 weeks after the completion of radiation therapy | 
| Change of patient-reported outcome from baseline | BREAST-Q questionnaire is used to evaluate patient-reported outcome. | 6 months after radiation therapy | 
| Change of patient-reported outcome from baseline | BREAST-Q questionnaire is used to evaluate patient-reported outcome. | 1 year after radiation therapy | 
| Change of patient-reported outcome from baseline | BREAST-Q questionnaire is used to evaluate patient-reported outcome. | 2 year after radiation therapy | 
| Change of patient-reported outcome from baseline | BREAST-Q questionnaire is used to evaluate patient-reported outcome. | 5 year after radiation therapy | 
| Physician assessed toxicity | CTCAE version 4.03 is used to evaluate physician-assessed toxicities. | After 2-3 weeks after the start of radiation therapy | 
| Physician assessed toxicity | CTCAE version 4.03 is used to evaluate physician-assessed toxicities. | 2-3 weeks after the completion of radiation therapy | 
| Physician assessed toxicity | CTCAE version 4.03 is used to evaluate physician-assessed toxicities. | 6 months after radiation therapy | 
| Physician assessed toxicity | CTCAE version 4.03 is used to evaluate physician-assessed toxicities. | 1 year after radiation therapy | 
| Physician assessed toxicity | CTCAE version 4.03 is used to evaluate physician-assessed toxicities. | 2 year after radiation therapy | 
| Physician assessed toxicity | CTCAE version 4.03 is used to evaluate physician-assessed toxicities. | 5 year after radiation therapy |