Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy
- Conditions
- Breast Cancer Female
- Registration Number
- NCT03523078
- Lead Sponsor
- Yonsei University
- Brief Summary
This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 500
Inclusion Criteria
- Pathologically confirmed invasive breast carcinoma
- Women who underwent mastectomy and breast reconstruction
- Good performance status (ECOG 0-1)
Read More
Exclusion Criteria
- Recurrent breast cancer
- History of ipsilateral breast irradiation
Read More
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline of Breast-Q questionnaire score 1 year after the last reconstructive procedures/surgery (allowed plus 8 weeks) Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)
- Secondary Outcome Measures
Name Time Method Reconstruction complications within 1 year after last reconstruction procedures (plus 8 weeks) Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)
Trial Locations
- Locations (1)
Severance Hospital
🇰🇷Seoul, Korea, Korea, Republic of