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Sensory Morbidity Following Breast Surgery

Sensory Morbidity Following Breast Surgery

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00625924
Enrollment
290
Registered
2008-02-29
Start date
2008-02-29
Completion date
2014-01-31
Last updated
2014-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Plastic surgery, reconstruction

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.

Interventions

BEHAVIORALquestionnaires

Patients will be evaluated at one time point using the Breast Sensation Assessment Score (BSAS©), the SF-36 Health Survey, the MSKCC BREAST Q, the Brief Pain Inventory, the Hopwood Body Image Scale, the Profile of Mood States - Brief Version (POMS - BRF), and the 'Patient Demographic and Treatment Information Form'

Sponsors

Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026