Sensory Morbidity Following Breast Surgery

Memorial Sloan Kettering Cancer Center1 site in 1 country290 target enrollmentFebruary 2008

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 290
Locations: 1
Primary Endpoint: To evaluate the prevalence, severity and level of distress of subjective breast sensations following mastectomy and postmastectomy reconstruction.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The goal of the study is measure breast sensations after breast surgery. The results of this study will help surgeons better understand breast sensations and may improve the way surgery is done.

Registry

clinicaltrials.gov

Start Date

February 2008

End Date

January 2014

Last Updated

12 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The Samples used will be derived from three cohorts below and will only include patients who have completed mastectomy or reconstruction within 1-5 years of enrollment.
•Patients who have undergone immediate, two-stage expander/implant postmastectomy reconstruction
•Patients who have undergone immediate, autogenous tissue flap reconstruction following mastectomy
•Patients who have undergone mastectomy alone
•Patients at least 21 years of age
•Patients who completed mastectomy ± immediate post-mastectomy reconstruction at least one year but no longer than five years prior to study entry

Exclusion Criteria

•Patients who have had any of the following:
•delayed reconstruction (no reconstruction at time of surgery) combined autogenous tissue/implant breast reconstruction, and/or
•Patients who have a pre-surgical history of complex regional pain syndrome
•Patients who have had radiation therapy
•Patients who have had a local recurrence
•Patients who do not speak the English language (validated translations of key questionnaires are not available).

Outcomes

Primary Outcomes

To evaluate the prevalence, severity and level of distress of subjective breast sensations following mastectomy and postmastectomy reconstruction.

Time Frame: conclusion of the study

Secondary Outcomes

To compare sensory morbidity following three types of breast surgery: tissue expander/implant breast reconstruction, autogenous tissue reconstruction, and no reconstruction.(conclusion of the study)