Sponsor study identifier
observational
240
1 country
1
Study Start
July 7, 2020
Actual (reported)Primary Completion
November 8, 2021
Actual (reported)Study Completion
November 8, 2021
Actual (reported)The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 8, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 7, 2020
Actual (reported)July 14, 2020
Actual (reported)July 20, 2020
Actual (reported)November 8, 2021
Actual (reported)November 8, 2021
Actual (reported)Compare the physical well-being Q-score derived from the BREAST-Q between the two groups
The physical well-being module is one of the domains of the BREAST-Q that can be administered in isolation. Patients answer specific questions with answers that range from 1-4 to 1-5. Upon completion of this component of the survey, a physical well-being-specific numerical score is generated. This is then converted, based on previously published Rasch-modeling to generate a Q-score whose values range from 0-100. This same approach is used for all other domains of the BREAST-Q. Pre- versus postoperative Q-scores for physical well-being can be directly compared to study the impact of surgery on physical well-being. Similarly, the physical-well-being domain can be readministered to provide a longitudinal assessment of physical function over time.
Completion of study (estimated to be 30 months)
Satisfaction with outcome
Completion of study (estimated to be 30 months)
Satisfaction with breasts
Completion of study (estimated to be 30 months)
Upper extremity function as measured by PROMIS Upper Extremity Short Form 7a
Completion of study (estimated to be 30 months)
-Participants will complete the post-mastectomy breast reconstruction physical well-being survey
-Participants will complete the 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Participants who undergone breast reconstruction surgery with plastic surgery faculty at the Washington University School of Medicine Division of Plastic and Reconstructive Surgery.
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Terence Myckatyn, M.D.
Washington University School of Medicine
240 participants (actual enrollment reported by the registry).
First Submitted
July 14, 2020
First Posted
July 20, 2020
Study Start
July 7, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
November 8, 2021
Actual (reported)Study Completion
November 8, 2021
Actual (reported)Last Updated
June 5, 2024
Record last verified: 2024-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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