Sensory Morbidity Following Breast Surgery

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: questionnaires

• Registration Number: NCT00625924
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-20
• Study First Submitted QC: 2008-02-20
• Study First Posted: 2008-02-29
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-14
• Last Update Posted: 2014-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 290

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3	questionnaires	mastectomy alone
1	questionnaires	autogenous tissue breast reconstruction
2	questionnaires	tissue expander/implant breast reconstruction

Primary Outcome Measures

Name	Time	Method
To evaluate the prevalence, severity and level of distress of subjective breast sensations following mastectomy and postmastectomy reconstruction.	conclusion of the study

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States