Post-mastectomy Breast Reconstruction
Conditions
Brief summary
The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction.
Interventions
OTHERPost-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.
Sponsors
Washington University School of Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare the physical well-being Q-score derived from the BREAST-Q between the two groups | Completion of study (estimated to be 30 months) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with outcome | Completion of study (estimated to be 30 months) | -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. |
| Upper extremity function as measured by PROMIS Upper Extremity Short Form 7a | Completion of study (estimated to be 30 months) | -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. |
| Satisfaction with breasts | Completion of study (estimated to be 30 months) | -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. |
Countries
United States
Outcome results
None listed