Sensory Morbidity Following Breast Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

February 20, 2008

Last Updated Date

January 28, 2010

Start Date ^ICMJE

February 2008

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00625924 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Sensory Morbidity Following Breast Surgery

Official Title ^ICMJE

Sensory Morbidity Following Breast Surgery

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.

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Crossover
Time Perspective: Retrospective

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

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'
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'

Study Arms / Comparison Groups

1
autogenous tissue breast reconstruction

Intervention: Behavioral: questionnaires
2
tissue expander/implant breast reconstruction

Intervention: Behavioral: questionnaires
3
mastectomy alone

Intervention: Behavioral: questionnaires

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

300

Estimated Completion Date

February 2011

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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).

Gender

Female

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Andrea Pusic, MD	212-639-5085
Contact: Babak Mehrara, MD	212-639-8639

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00625924

Responsible Party

Andrea Pusic, MD, FRCSC, Memorial Sloan-Kettering Cancer Center

Study ID Numbers ^ICMJE

08-009

Study Sponsor ^ICMJE

Memorial Sloan-Kettering Cancer Center

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Andrea Pusic, MD

Memorial Sloan-Kettering Cancer Center

Information Provided By

Memorial Sloan-Kettering Cancer Center

Verification Date

January 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP