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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00588419 |
The purpose of this study is to evaluate the return of sensation in the breast(s) following breast mastectomy with and without reconstruction. Four different sensations: touch, vibration, superficial pain, and temperature will be evaluated. In addition, we will look at factors that may contribute to the return of breast sensations.
Condition | Intervention |
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Breast Cancer Cancer |
Behavioral: breast exam and questionaire |
Study Type: | Observational |
Study Design: | Case-Only, Cross-Sectional |
Official Title: | Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction |
Estimated Enrollment: | 150 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | June 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Patients who have undergone mastectomy Patients who have undergone immediate, twostage expander/implant breast reconstruction; Patients who have undergone immediate, autogenous tissue flap reconstruction including: pedicled and/or free TRAM flap or DIEP flap reconstruction
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Behavioral: breast exam and questionaire
A physical examination of your breast(s), we will ask you to complete a short questionnaire that asks questions regarding sensations in your reconstructed breast(s) and another short questionnaire that asks questions regarding your medical and surgical history. The physical examination and the questionnaires will be completed in the outpatient clinic. This should take about 30 minutes to complete.
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This study entitled "The Quantification of Breast Sensations Following Postmastectomy Breast Reconstruction" will evaluate the recovery of sensation in the reconstructed as well as in the nonreconstructed breast. Touch, vibration, pain and temperature sensation will be objectively evaluated greater than 1 year following completion of reconstruction. Breast sensation following immediate, tissue expander/implant breast reconstruction will be compared with that following immediate, autogenous tissue reconstruction.
A formal sensory examination will be performed. SemmesWeinstein monofilaments will evaluate touchpressure sensation in the breast. A Bioesthesiometer will determine the recovery of vibratory sensation. Temperature sensation will be evaluated by application of warm and cool stimuli. Superficial pain sensation will be evaluated by application of sharp and dull stimuli.
A patient reported assessment of sensory changes in the breast will be administered to patients. The Breast Sensation Assessment Scale © is designed to measure the prevalence, severity, and distress of 18 different sensory symptoms following breast surgery. A "Patient Demographic and Treatment Information Form" and patients' medical records will be used to obtain demographic and treatment data. The role of confounding variables (including: patient age, breast volume, axillary procedures performed and adjuvant therapies received) on the recovery of sensation will be evaluated. The estimated accrual time for this study is 12 months.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients will be recruited by their attending surgeon when they return to their surgeon's office for a postoperative appointment following their qualifying surgery
Inclusion Criteria:
Exclusion Criteria:
Patients who have had any of the following:
Contact: Babak Mehrara, MD | mehrarab@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Babak Mehrara, MD mehrarab@mskcc.org |
Principal Investigator: | Babak Mehrara, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Babak Mehrara, MD ) |
Study ID Numbers: | 06-047 |
Study First Received: | December 24, 2007 |
Last Updated: | February 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00588419 History of Changes |
Health Authority: | United States: Institutional Review Board |
Breast Cancer Cancer Breast Sensation Postmastectomy Breast Reconstruction |
Skin Diseases Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |