Sensory Morbidity Following Breast Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2014-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

autogenous tissue breast reconstruction

questionnaires

Intervention Type BEHAVIORAL

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'

2

tissue expander/implant breast reconstruction

questionnaires

Intervention Type BEHAVIORAL

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'

3

mastectomy alone

questionnaires

Intervention Type BEHAVIORAL

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'

Interventions

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questionnaires

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'

Intervention Type BEHAVIORAL

questionnaires

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'

Intervention Type BEHAVIORAL

questionnaires

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'

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No