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NCT03523078 Clinical Trial

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

Breast Cancer Female Clinical Trial

Official title:
Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy: Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03523078
Other study ID # 4-2017-1108
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2018
Est. completion date February 1, 2024

Study information
Verified date September 2020
Source Yonsei University
Contact Yong Bae Kim, MD, PhD
Phone 82-2228-8095
Email ybkim3@yuhs.ac
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date February 1, 2024
Est. primary completion date February 1, 2024
Accepts healthy volunteers No
Gender Female
Age group 20 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Korea, Republic of Severance Hospital Seoul Korea

Sponsors (1)
Lead Sponsor Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) Before mastectomy & reconstruction surgery (allowed up to 8 weeks ago)
Primary 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) Immediate after the last reconstructive procedures/surgery (allowed plus 8 weeks)
Primary 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) 1 year after the last reconstructive procedures/surgery (allowed plus 8 weeks)
Secondary Reconstruction complications Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey) within 1 year after last reconstruction procedures (plus 8 weeks)
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