Clinical trial · Observational
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
NCT03523078CI-TRIAL-00047382unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast reconstructive surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Change from baseline of Breast-Q questionnaire score
- timeFrame
- Before mastectomy & reconstruction surgery (allowed up to 8 weeks ago)
- description
- Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)
- measure
- Change from baseline of Breast-Q questionnaire score
- timeFrame
- Immediate after the last reconstructive procedures/surgery (allowed plus 8 weeks)
- description
- Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)
- measure
- Change from baseline of Breast-Q questionnaire score
- timeFrame
- 1 year after the last reconstructive procedures/surgery (allowed plus 8 weeks)
- description
- Patient reported outcome measures include psychosocial functioning, patient treatment satisfaction, physical functioning, body image and pain. (Breast-Q survey)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDChung SY, Chang JS, Shin KH, Kim JH, Park W, Kim H, Kim K, Lee IJ, Yoon WS, Cha J, Lee KC, Kim JH, Choi JH, Ahn SJ, Ha B, Lee SY, Lee DS, Lee J, Shin SO, Lee SW, Choi J, Kim MY, Kim YJ, Im JH, Suh CO, Kim YB. Impact of radiation dose on complications among women with breast cancer who underwent breast reconstruction and post-mastectomy radiotherapy: A multi-institutional validation study. Breast. 2021 Apr;56:7-13. doi: 10.1016/j.breast.2021.01.003. Epub 2021 Jan 20. PMID 33517043
- DERIVEDChang JS, Song SY, Oh JH, Lew DH, Roh TS, Kim SY, Keum KC, Lee DW, Kim YB. Influence of Radiation Dose to Reconstructed Breast Following Mastectomy on Complication in Breast Cancer Patients Undergoing Two-Stage Prosthetic Breast Reconstruction. Front Oncol. 2019 Apr 9;9:243. doi: 10.3389/fonc.2019.00243. eCollection 2019. PMID 31024845