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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04477538
Recruitment Status : Recruiting
First Posted : July 20, 2020
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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

Condition or disease Intervention/treatment
Post-mastectomy Breast Reconstruction Other: Post-mastectomy breast reconstruction physical well-being survey

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Operative Approach on Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction
Actual Study Start Date : July 7, 2020
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Compare the physical well-being Q-score derived from the BREAST-Q between the two groups [ Time Frame: 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 :
  1. Satisfaction with outcome [ Time Frame: 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.

  2. Satisfaction with breasts [ Time Frame: 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.

  3. Upper extremity function as measured by PROMIS Upper Extremity Short Form 7a [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04477538


Contacts
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Contact: Terence Myckatyn, M.D. 314-996-3255 myckatyn@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Terence Myckatyn, M.D.    314-996-3255    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: Julie Margenthaler, M.D.         
Sub-Investigator: Marissa Tenenbaum, M.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Terence Myckatyn, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04477538    
Other Study ID Numbers: 202006199
First Posted: July 20, 2020    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No