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Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery: Development and Validation of a Patient-Reported Outcomes Instrument


N/A
18 Years
85 Years
Open (Enrolling)
Both
Breast Cancer, Breast Surgery, Breast Reconstruction, Breast Reduction, Breast Augmentation

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Trial Information

Measuring Patient Satisfaction and Quality of Life Following Body Image Altering Surgery: Development and Validation of a Patient-Reported Outcomes Instrument


Inclusion Criteria:



- All stages (1-4)

- Age > or = to 18 to 85 years.

- Postoperative Group: Male and Female patients who have undergone mastectomy, breast
reconstruction, reduction, augmentation, bariatric or body contouring surgery between
1 month to 8 years ago

Or

- Preoperative Group: Male and Female patients who are scheduled to undergo mastectomy,
breast reconstruction, reduction, or augmentation or body contouring surgery

Exclusion Criteria:

- Inability to speak or understand English

- Active psychiatric illness, cognitive or sensory impairment

- Physical impairment that may prevent filling out a paper and pencil survey or
responding to interview questions

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To develop and validate a new patient derived measure of satisfaction with breast surgery.

Outcome Time Frame:

conclusion of study

Safety Issue:

No

Principal Investigator

Andrea Pusic, M.D., M.H.S.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

05-058

NCT ID:

NCT00605670

Start Date:

June 2005

Completion Date:

June 2014

Related Keywords:

  • Breast Cancer
  • Breast Surgery
  • Breast Reconstruction
  • Breast Reduction
  • Breast Augmentation
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
University of Pittsburgh Medical CenterPittsburgh, Pennsylvania  15213
John Hopkins Medical CenterBaltimore, Maryland  21287
Dartmouth Medical CenterLebanon, New Hampshire