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

September 28, 2020 updated by: Yonsei University

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Yong Bae Kim, MD, PhD
  • Phone Number: 82-2228-8095
  • Email: ybkim3@yuhs.ac

Study Locations

  • Korea, Republic of
    • Korea
      • Seoul, Korea, Korea, Republic of, 120-752
        • Recruiting
        • Severance Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women undergoing reconstruction surgery after mastectomy at an academic center

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline of Breast-Q questionnaire score
Time Frame: Before 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)
Before mastectomy & reconstruction surgery (allowed up to 8 weeks ago)
Change from baseline of Breast-Q questionnaire score
Time Frame: Immediate 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)
Immediate after the last reconstructive procedures/surgery (allowed plus 8 weeks)
Change from baseline of Breast-Q questionnaire score
Time Frame: 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)
1 year after the last reconstructive procedures/surgery (allowed plus 8 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reconstruction complications
Time Frame: 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)
within 1 year after last reconstruction procedures (plus 8 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2018

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

May 1, 2018

First Submitted That Met QC Criteria

May 1, 2018

First Posted (Actual)

May 14, 2018

Study Record Updates

Last Update Posted (Actual)

September 29, 2020

Last Update Submitted That Met QC Criteria

September 28, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2017-1108

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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