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

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

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

Study Overview

• Status: Recruiting
• Conditions: Post-mastectomy Breast Reconstruction
• Intervention / Treatment: Other: Post-mastectomy breast reconstruction physical well-being survey

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

• Study Contact: Name: Terence Myckatyn, M.D.; Phone Number: 314-996-3255; Email: myckatyn@wustl.edu

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Sub-Investigator: Julie Margenthaler, M.D.
      • Contact: Terence Myckatyn, M.D.; Phone Number: 314-996-3255; Email: myckatyn@wustl.edu
      • Principal Investigator: Terence Myckatyn, M.D.
      • Sub-Investigator: Janessa Sullivan
      • Sub-Investigator: Danielle Cooper, M.D.
      • Sub-Investigator: Grace Keane
      • Sub-Investigator: Marissa Tenenbaum, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants who undergone breast reconstruction surgery with plastic surgery faculty at the Washington University School of Medicine Division of Plastic and Reconstructive Surgery.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with prepectoral reconstruction; -Participants will complete the post-mastectomy breast reconstruction physical well-being survey	Other: 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.
Participants with postpectoral reconstruction; -Participants will complete the post-mastectomy breast reconstruction physical well-being survey	Other: 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.

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)

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Terence Myckatyn, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 14, 2020
• First Posted (Actual): July 20, 2020

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 202006199

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No