Sensory Morbidity Following Breast Surgery

Study Overview
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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.

Official Title
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Sensory Morbidity Following Breast Surgery

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: questionnaires
* Behavioral: questionnaires
* Behavioral: questionnaires


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>autogenous tissue breast reconstruction | Behavioral: questionnaires<br>* 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'<br>|
| 2<br>tissue expander/implant breast reconstruction | Behavioral: questionnaires<br>* 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'<br>|
| 3<br>mastectomy alone | Behavioral: questionnaires<br>* 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'<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plastic surgery, reconstruction