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

Post-mastectomy Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04477538
• Other study ID #: 202006199
• Status: Terminated
• Start date: July 7, 2020
• Est. completion date: November 8, 2021

Study information

• Verified date: June 2024
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 240
• Est. completion date: November 8, 2021
• Est. primary completion date: November 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post-mastectomy Breast Reconstruction

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)

External Links

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