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Sensory Morbidity Following Breast Surgery

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ClinicalTrials.gov Identifier: NCT00625924
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : January 16, 2014
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date February 20, 2008
First Posted Date February 29, 2008
Last Update Posted Date January 16, 2014
Study Start Date February 2008
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 20, 2008)
To evaluate the prevalence, severity and level of distress of subjective breast sensations following mastectomy and postmastectomy reconstruction. [ Time Frame: conclusion of the study ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00625924 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 20, 2008)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Sensory Morbidity Following Breast Surgery
Official Title 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 Not Provided
Study Type Observational
Study Design Observational Model: Case-Crossover
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population MSKCC clinics
Condition 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'
  • 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 Groups/Cohorts
  • 1
    autogenous tissue breast reconstruction
    Intervention: Behavioral: questionnaires
  • 2
    tissue expander/implant breast reconstruction
    Intervention: Behavioral: questionnaires
  • 3
    mastectomy alone
    Intervention: Behavioral: questionnaires
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 30, 2010)
290
Original Estimated Enrollment
 (submitted: February 20, 2008)
300
Actual Study Completion Date January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility 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 1-5 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).
Sex/Gender
Sexes Eligible for Study: Female
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00625924
Other Study ID Numbers 08-009
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Andrea Pusic, MD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date January 2014