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

NCT04477538 | Terminated

• 1 other identifier: 202006199
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Post-mastectomy Breast Reconstruction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Satisfaction with outcome

  Completion of study (estimated to be 30 months)

• Satisfaction with breasts

  Completion of study (estimated to be 30 months)

• Upper extremity function as measured by PROMIS Upper Extremity Short Form 7a

  Completion of study (estimated to be 30 months)

Study Arms (2)

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

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

Interventions

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.

Participants with postpectoral reconstruction; Participants with prepectoral reconstruction

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Known distant metastatic disease

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

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

Study Officials

• Terence Myckatyn, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2020
• First Posted: July 20, 2020
• Study Start: July 7, 2020
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: June 5, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)