Quantitative Analysis of Outcomes in Breast Reconstruction
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 12/1/2018 |
| Start Date: | May 2008 |
| End Date: | May 2019 |
Multimodality Anthropometric Analysis for Quantitative Assessment of Outcomes in Breast Reconstructive Surgery
The first objective of this study is to assess the accuracy of digital image-processing
techniques to provide measurements of human breast physical dimensions. The ultimate
usefulness of these techniques is to develop quantitative outcome measures of the visual
appearance of breast after local treatments for breast cancer. These measures will be used to
improve clinical outcomes from multimodality therapy that includes surgery and radiotherapy
and form the basis for the future development of patient decision making aids. The second
objective is to evaluate the relationship between patient reported body image outcomes and
measurement of human breast physical dimensions for patients with breast cancer.
techniques to provide measurements of human breast physical dimensions. The ultimate
usefulness of these techniques is to develop quantitative outcome measures of the visual
appearance of breast after local treatments for breast cancer. These measures will be used to
improve clinical outcomes from multimodality therapy that includes surgery and radiotherapy
and form the basis for the future development of patient decision making aids. The second
objective is to evaluate the relationship between patient reported body image outcomes and
measurement of human breast physical dimensions for patients with breast cancer.
If you agree to take part in this study, you will be asked to fill out a brief questionnaire
packet. This packet contains questions about how you feel about your appearance and your
overall well-being. You will be asked to have photographs of your breast(s) taken with two
different types of digital cameras (2D and 3D). These are the same type of photographs
routinely taken for all patients having breast reconstructive surgery. The photographs and
measurements will be taken during your routine clinic visit. You will not be identifiable in
the photographs.
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.
packet. This packet contains questions about how you feel about your appearance and your
overall well-being. You will be asked to have photographs of your breast(s) taken with two
different types of digital cameras (2D and 3D). These are the same type of photographs
routinely taken for all patients having breast reconstructive surgery. The photographs and
measurements will be taken during your routine clinic visit. You will not be identifiable in
the photographs.
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.
Inclusion Criteria:
1. Female
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:
1. Women who have undergone previous bilateral mastectomy without reconstruction.
2. Women who are unable to stand unassisted for 2 minutes.
3. Diagnosis of serious mental illness (e.g. schizophrenia) or cognitive impairment.
We found this trial at
1
site
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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