Quantitative Analysis of Outcomes in Breast Reconstruction

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00677430
First received: May 9, 2008
Last updated: February 11, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Questionnaire
Procedure: Digital Imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Multimodality Anthropometric Analysis for Quantitative Assessment of Outcomes in Breast Reconstructive Surgery

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Evaluate accuracy of digital image-processing techniques used to provide the physical dimensions of human breasts. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: May 2008
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Behavioral: Questionnaire
A brief questionnaire packet will be completed.
Other Name: Survey
Procedure: 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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Study participants with breast cancer that have had or are about to have breast reconstructive surgery.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677430

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Gregory P. Reece, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00677430     History of Changes
Other Study ID Numbers: 2004-0899
Study First Received: May 9, 2008
Last Updated: February 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Breast Reconstruction
Digital Imaging
Questionnaire
Survey

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 01, 2014