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Measuring Patient Expectations for Breast Reconstruction: Development and Validation of a Patient-Reported Outcomes Instrument


N/A
18 Years
75 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Measuring Patient Expectations for Breast Reconstruction: Development and Validation of a Patient-Reported Outcomes Instrument


OBJECTIVES:

- Develop and validate a questionnaire to evaluate preoperative expectations about breast
reconstruction in women with breast cancer or other conditions.

- Determine variations in expectations related to patient characteristics.

- Develop educational modules to help patients understand realistic outcomes.

- Identify patient groups at risk for dissatisfaction.

OUTLINE: This is a 3-part study.

- Part 1 (first 80 patients): Both preoperative and postoperative patients (50 patients
total) undergo an interview by a research study assistant about their expectations for
breast reconstructive surgery. Some of these patients will also complete a pilot
version of a questionnaire about their expectations for breast reconstructive surgery
(30 patients total).

- Part 2 (next 200 patients): Preoperative patients complete questionnaires (the
preliminary questionnaire developed after part 1 and the MSKCC BREAST-Q [Reconstruction
Module]) about their expectations for breast reconstructive surgery after patient
education about breast reconstructive surgery. Some of these patients (100 patients)
also complete the Brief Cope addressing emotional expression and emotional processing
styles of coping, Impact of Events Scale, and Life Orientation Test-Revised (LOT-R)
questionnaires.

- Part 3 (final 200 patients): Preoperative patients complete a questionnaire (final
questionnaire developed after part 2) about their expectations for breast
reconstructive surgery after patient education about breast reconstruction and once
after surgery. Patients also complete the Breast Reconstruction Outcomes Questionnaire
(MSKCC BREAST-Q) once before surgery (after patient education) and once after surgery
measuring patient satisfaction and quality of life. A small group of patients complete
the Body Image Scale (BIS) and the LOT-R addressing body image, sexuality, personal
well-being, and lifestyle.


Inclusion Criteria:



- Female.

- Age > or = to 18 to 75 years.

- Patients who are presenting for consultation about breast reconstruction

Exclusion Criteria:

- Inability to speak or understanding English

- Inability to provide meaningful informed consent due to physical, cognitive, or
psychiatric disability.

- Prior breast reconstruction surgery.

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

Item reduction

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Andrea L. Pusic, MD, MHS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07-024

NCT ID:

NCT00471601

Start Date:

March 2007

Completion Date:

March 2014

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IA breast cancer
  • stage IB breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
New School for Social ResearchNew York, New York  10003