Sensory Morbidity Following Breast Surgery

Breast Cancer Clinical Trial

Official title:

Sensory Morbidity Following Breast Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00625924
• Other study ID #: 08-009
• Status: Completed
• Phase: N/A
• First received: February 20, 2008
• Last updated: January 14, 2014
• Start date: February 2008
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Observational Model: Case-Crossover, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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'
• 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'
• 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'

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the prevalence, severity and level of distress of subjective breast sensations following mastectomy and postmastectomy reconstruction.		conclusion of the study	No
Secondary	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	No

External Links

•   Memorial Sloan-Kettering Cancer Center