Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction
NCT ID: NCT04477538
Last Updated: 2024-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
240 participants
OBSERVATIONAL
2020-07-07
2021-11-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Participants with prepectoral reconstruction
-Participants will complete the post-mastectomy breast reconstruction physical well-being survey
Post-mastectomy breast reconstruction physical well-being survey
-The survey will ascertain: function status (BREAST Q - Physical Well Being Module and PROMIS upper extremity function), former interaction with physical or occupational therapy, amount of narcotics taken weekly due to chest/neck/breast pain, amount of Tylenol or similar anti-inflammatories taken weekly due to chest/neck/breast pain, and amount of muscle relaxants taken weekly due to chest/neck/breast pain.
Participants with postpectoral reconstruction
-Participants will complete the post-mastectomy breast reconstruction physical well-being survey
Post-mastectomy breast reconstruction physical well-being survey
-The survey will ascertain: function status (BREAST Q - Physical Well Being Module and PROMIS upper extremity function), former interaction with physical or occupational therapy, amount of narcotics taken weekly due to chest/neck/breast pain, amount of Tylenol or similar anti-inflammatories taken weekly due to chest/neck/breast pain, and amount of muscle relaxants taken weekly due to chest/neck/breast pain.
Interventions
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Post-mastectomy breast reconstruction physical well-being survey
-The survey will ascertain: function status (BREAST Q - Physical Well Being Module and PROMIS upper extremity function), former interaction with physical or occupational therapy, amount of narcotics taken weekly due to chest/neck/breast pain, amount of Tylenol or similar anti-inflammatories taken weekly due to chest/neck/breast pain, and amount of muscle relaxants taken weekly due to chest/neck/breast pain.
Eligibility Criteria
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Inclusion Criteria
* At least 18 years of age
* Had a mastectomy for breast cancer or cancer prevention any time between 01/01/2010 and 06/30/2021.
* Has undergone breast reconstruction surgery with plastic surgery faculty at the Washington University School of Medicine Division of Plastic and Reconstructive Surgery.
* Able to understand and willing to sign an IRB-approved written informed consent document.
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Terence Myckatyn, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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202006199
Identifier Type: -
Identifier Source: org_study_id
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