Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00588419

Collaborator

(none)

153

Enrollment

Location

178.2

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Breast Cancer Cancer	Behavioral: breast exam and questionaire

Detailed Description

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.

Study Design

Study Type:

Observational

Actual Enrollment :

153 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Quantification of Breast Sensation Following Postmastectomy Breast Reconstruction

Study Start Date :

Jun 1, 2006

Actual Primary Completion Date :

Apr 7, 2021

Actual Study Completion Date :

Apr 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
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	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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Evaluate the degree of touch, vibration, superficial pain, and temperature sensation recovered in the postmastectomy as well as in the reconstructed breast and to compare the sensations recovered in the different groups. [1 year]

Secondary Outcome Measures

The secondary objective is to compare the sensations recovered following tissue expander/implant breast reconstruction with sensations recovered following autogenous tissue reconstruction. [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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
Patients at least 21 years of age
Patients at least 1 year from the time of mastectomy or completion of immediate, postmastectomy reconstruction