Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy

Yonsei University500 enrolled

Overview

This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Breast Cancer Female

Interventions

Breast reconstructive surgeryPROCEDURE

All sorts of breast reconstructive surgery are allowed in this study in terms of timing, autologous/prosthetic and so forth.

Eligibility

Sex: FEMALEMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Pathologically confirmed invasive breast carcinoma * Women who underwent mastectomy and breast reconstruction * Good performance status (ECOG 0-1) Exclusion Criteria: * Recurrent breast cancer * History of ipsilateral breast irradiation

Locations (1)

Severance Hospital

Seoul, Korea, South Korea

RECRUITING

Outcomes

Primary Outcomes

Change from baseline of Breast-Q questionnaire score

Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)

Time frame: Before mastectomy & reconstruction surgery (allowed up to 8 weeks ago)

Change from baseline of Breast-Q questionnaire score

Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)

Time frame: Immediate after the last reconstructive procedures/surgery (allowed plus 8 weeks)

Change from baseline of Breast-Q questionnaire score

Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)

Time frame: 1 year after the last reconstructive procedures/surgery (allowed plus 8 weeks)

Secondary Outcomes

Reconstruction complications

Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)

Time frame: within 1 year after last reconstruction procedures (plus 8 weeks)

Central Contacts

Yong Bae Kim, MD, PhD

CONTACT

82-2228-8095 ybkim3@yuhs.ac

Data from ClinicalTrials.gov

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