Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction

Study Overview
=================
Brief Summary
-----------------
The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction.

Official Title
-----------------
The Impact of Operative Approach on Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction

Conditions
-----------------
Post-mastectomy Breast Reconstruction

Intervention / Treatment
-----------------
* Other: Post-mastectomy breast reconstruction physical well-being survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female 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: -Known distant metastatic disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants with prepectoral reconstruction<br>-Participants will complete the post-mastectomy breast reconstruction physical well-being survey | Other: Post-mastectomy breast reconstruction physical well-being survey<br>* -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.<br>|
| Participants with postpectoral reconstruction<br>-Participants will complete the post-mastectomy breast reconstruction physical well-being survey | Other: Post-mastectomy breast reconstruction physical well-being survey<br>* -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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |