Quantitative Analysis of Outcomes in Breast Reconstruction
NCT ID: NCT00677430
Last Updated: 2021-04-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
224 participants
OBSERVATIONAL
2008-05-31
2021-04-09
Brief Summary
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Detailed Description
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The photographs will be used to develop automated methods for evaluating the appearance and shape of the breasts.
You may be asked to complete additional follow-up visits for this study. These visits would take place at a regularly-scheduled clinic visit that takes place just before a surgical procedure is planned. At these visits you would be asked to fill out another questionnaire packet and to allow the research the research staff to repeat the photographs. The number of follow-up visits needed would depend on your individual treatment plan. A final study visit would take place once you feel you are finished with your breast reconstructive process. At this point, your participation in the study would be completed. Breast reconstruction is different for each patient. The length of time of the reconstructive process depends on the procedure(s) that you and your surgeon have agreed upon. These options will be discussed at your regularly scheduled clinic appointments.
This is an investigational study. A total of up to 300 patients will take part in this study. All will be enrolled at UTMDACC.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Questionnaire + Digital Imaging
A brief questionnaire packet will be completed. Photographs of the breast(s) will be taken with two different types of digital cameras (2D and 3D). The photos will be used to develop automated methods for evaluating the appearance and shape of the breasts.
Questionnaire
A brief questionnaire packet will be completed.
Digital Imaging
Photographs of the breast(s) will be taken with two different types of digital cameras (2D and 3D). The photos will be used to develop automated methods for evaluating the appearance and shape of the breasts.
Interventions
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Questionnaire
A brief questionnaire packet will be completed.
Digital Imaging
Photographs of the breast(s) will be taken with two different types of digital cameras (2D and 3D). The photos will be used to develop automated methods for evaluating the appearance and shape of the breasts.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age greater than 21 years old.
3. Candidate who has had or is planning to have breast reconstructive surgery and has at least one breast mound.
4. Willing to participate in the study and able to complete informed consent.
5. Proficient at reading and speaking English.
Exclusion Criteria
2. Women who are unable to stand unassisted for 2 minutes.
3. Diagnosis of serious mental illness (e.g. schizophrenia) or cognitive impairment.
21 Years
FEMALE
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Gregory P. Reece, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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RSGPB-09-157-01-CPPB
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2004-0899
Identifier Type: -
Identifier Source: org_study_id
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