Sensory Morbidity Following Breast Surgery - Full Text View

Sponsor:	Memorial Sloan-Kettering Cancer Center
Information provided by:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT00625924

Purpose

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.

Condition	Intervention
Breast Cancer	Behavioral: questionnaires

Study Type:	Observational
Study Design:	Case-Crossover, Retrospective
Official Title:	Sensory Morbidity Following Breast Surgery

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To evaluate the prevalence, severity and level of distress of subjective breast sensations following mastectomy and postmastectomy reconstruction. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To compare sensory morbidity following three types of breast surgery: tissue expander/implant breast reconstruction, autogenous tissue reconstruction, and no reconstruction. [ Time Frame: conclusion of the study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	February 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 autogenous tissue breast reconstruction	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'
2 tissue expander/implant breast reconstruction	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'
3 mastectomy alone	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'

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

MSKCC clinics

Criteria

Inclusion Criteria:

The Samples used will be derived from three cohorts below and will only include patients who have completed mastectomy or reconstruction within 1-3 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 three 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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00625924

Contacts

Contact: Andrea Pusic, MD		pusica@mskcc.org
Contact: Babak Mehrara		mehrarab@mskcc.org

Locations

United States, New York
Memorial Sloan Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Andrea Pusic, MD pusica@mskcc.org
Contact: Babak Mehrara, MD mehrarab@mskcc.org
Principal Investigator: Adrea Pusic, MD

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Andrea Pusic, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center ( Andrea Pusic, MD, FRCSC )
Study ID Numbers:	08-009
Study First Received:	February 20, 2008
Last Updated:	September 18, 2009
ClinicalTrials.gov Identifier:	NCT00625924 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Plastic surgery
reconstruction

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on November 25, 2009