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PI decision
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The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with prepectoral reconstruction | -Participants will complete the post-mastectomy breast reconstruction physical well-being survey |
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| Participants with postpectoral reconstruction | -Participants will complete the post-mastectomy breast reconstruction physical well-being survey |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Post-mastectomy breast reconstruction physical well-being survey | Other | -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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with outcome | -The satisfaction with outcome module is one of the domains of the BREAST-Q. Patients answer specific questions with answers that range from 1-3. Upon completion of this component of the survey, a 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. | Completion of study (estimated to be 30 months) |
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Inclusion Criteria:
Exclusion Criteria:
-Known distant metastatic disease
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Participants who undergone breast reconstruction surgery with plastic surgery faculty at the Washington University School of Medicine Division of Plastic and Reconstructive Surgery.
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| Name | Affiliation | Role |
|---|---|---|
| Terence Myckatyn, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| Satisfaction with breasts | -The satisfaction with breast module is one of the domains of the BREAST-Q. Patients answer specific questions with answers that range from 1-4. Upon completion of this component of the survey, a 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. | Completion of study (estimated to be 30 months) |
| Upper extremity function as measured by PROMIS Upper Extremity Short Form 7a | -Questions regarding upper extremity function as reported by patient. Answers range from 5=without any difficulty to 1=unable to do. The total score ranges from 5-35. | Completion of study (estimated to be 30 months) |