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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03523078
Enrollment
500
Registered
2018-05-14
Start date
2018-02-01
Completion date
2024-02-01
Last updated
2020-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female

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.

Interventions

PROCEDUREBreast reconstructive surgery

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline of Breast-Q questionnaire scoreBefore mastectomy & reconstruction surgery (allowed up to 8 weeks ago)Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)

Secondary

MeasureTime frameDescription
Reconstruction complicationswithin 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)

Countries

South Korea

Contacts

Primary ContactYong Bae Kim, MD, PhD
ybkim3@yuhs.ac82-2228-8095

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026