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

N/ATerminatedNCT04477538

Washington University School of Medicine240 enrolled

Overview

The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction.

Study Type

OBSERVATIONAL

Enrollment

240

Conditions

Post-mastectomy Breast Reconstruction

Interventions

Post-mastectomy breast reconstruction physical well-being surveyOTHER

-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

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Outcomes

Primary Outcomes

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.

Time frame: Completion of study (estimated to be 30 months)

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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