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

Terminated

• Conditions: Post-mastectomy Breast Reconstruction
• Interventions: Other: Post-mastectomy breast reconstruction physical well-being survey

• Registration Number: NCT04477538
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-07-07
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-14
• Study First Posted: 2020-07-20
• Primary Completion: 2021-11-08
• Study Completion: 2021-11-08
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 240

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.

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Exclusion Criteria

-Known distant metastatic disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants with postpectoral reconstruction	Post-mastectomy breast reconstruction physical well-being survey	-Participants will complete the post-mastectomy breast reconstruction physical well-being survey
Participants with prepectoral reconstruction	Post-mastectomy breast reconstruction physical well-being survey	-Participants will complete the post-mastectomy breast reconstruction physical well-being survey

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States