Post-mastectomy Breast ReconstructionNCT04477538
Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction
An observational study of Post-mastectomy Breast Reconstruction, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-mastectomy Breast Reconstruction
- What is being tested?
- Post-mastectomy breast reconstruction physical well-being survey
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2020to 8 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- -Known distant metastatic disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: 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.
- Conditions
- Post-mastectomy Breast Reconstruction
- Being tested
- Post-mastectomy breast reconstruction physical well-being survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-mastectomy breast reconstruction physical well-being surveyOther
-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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with prepectoral reconstruction | -Participants will complete the post-mastectomy breast reconstruction physical well-being survey Receives: 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 Receives: Other: Post-mastectomy breast reconstruction physical well-being survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Completion of study (estimated to be 30 months)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Completion of study (estimated to be 30 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2020
- Study start7 Jul 2020
- Primary completion8 Nov 2021
- Study completion8 Nov 2021
Why it stopped: PI decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-mastectomy Breast ReconstructionStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terence Myckatyn, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04477538
- Sponsor's protocol ID
- 202006199
- Status last verified
- Jun 2024
- First submitted
- 14 Jul 2020
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Operative Approach on Long Term Function Outcomes and Pain in Implant-based Post-mastectomy Breast Reconstruction
- ClinicalTrials.gov ID
- NCT04477538
- Acronym / sponsor ID
- 202006199
- Conditions
- Post-mastectomy Breast Reconstruction
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI decision
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 8 Nov 2021 (actual)
- Study completion
- 8 Nov 2021 (actual)
- First posted
- 20 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this proposal is to broadly assess patient physical functioning following breast reconstruction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with prepectoral reconstruction | – | Other: Post-mastectomy breast reconstruction physical well-being survey-Participants will complete the post-mastectomy breast reconstruction physical well-being survey |
| Participants with postpectoral reconstruction | – | Other: Post-mastectomy breast reconstruction physical well-being survey-Participants will complete the post-mastectomy breast reconstruction physical well-being survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -Known distant metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Participants with postpectoral reconstruction, Participants with prepectoral reconstruction |
Primary outcome
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.
3 secondary outcomes
Satisfaction with outcome
Time frame: Completion of study (estimated to be 30 months)
Satisfaction with breasts
Time frame: Completion of study (estimated to be 30 months)
Upper extremity function as measured by PROMIS Upper Extremity Short Form 7a
Time frame: Completion of study (estimated to be 30 months)
Results and safety
The study was stopped early (reason given: PI decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Post-mastectomy Breast Reconstruction
Not yet recruiting
Thermal Preconditioning in Mastectomy Patients With Immediate Breast Reduction
Breast Reconstruction After Mastectomy
Not yet recruiting
Synthetic Electrospun Fiber Matrix in Abdominal Wall Donor Sites for Breast Reconstruction
Breast Reconstruction, Deep Inferior Epigastric Perforator
Not yet recruitingPhase 4
Does Nerve Grafting Improve Sensation After Nipple-Sparing Mastectomy With Implant Reconstruction?
Breast Reconstruction Following Mastectomy
Recruiting
Hypofractionated vs. Conventionally Fractionated Postmastectomy Radiotherapy After Implant-Based Reconstruction
Breast Cancer, Implant Breast Reconstruction
Active, not recruitingObservational study
Evaluating Mechanical Properties of Post-Mastectomy Skin Flaps to Estimate Reconstruction Risks, the EMPOWER Study
Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terence Myckatyn, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-mastectomy Breast Reconstruction, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2024.