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Sensory Morbidity Following Breast Surgery

Memorial Sloan Kettering Cancer Center (MSK) logo

Memorial Sloan Kettering Cancer Center (MSK)

Status

Completed

Conditions

Breast Cancer

Treatments

Behavioral: questionnaires

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

290 patients

Sex

Female

Ages

21+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

290 participants in 3 patient groups

1
Description:
autogenous tissue breast reconstruction
Treatment:
Behavioral: questionnaires
Behavioral: questionnaires
Behavioral: questionnaires
2
Description:
tissue expander/implant breast reconstruction
Treatment:
Behavioral: questionnaires
Behavioral: questionnaires
Behavioral: questionnaires
3
Description:
mastectomy alone
Treatment:
Behavioral: questionnaires
Behavioral: questionnaires
Behavioral: questionnaires

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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