Development of a Questionnaire to Evaluate Patient Expectations for Breast Reconstruction in Women With Breast Cancer or Other Conditions



Status:Active, not recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 75
Updated:4/6/2019
Start Date:March 2007
End Date:September 2019

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

RATIONALE: A questionnaire that evaluates a patient's expectations about breast
reconstruction surgery may help doctors improve patient education before surgery and increase
patient satisfaction after surgery.

PURPOSE: This clinical trial is developing a questionnaire to evaluate patient expectations
for breast reconstruction in women with breast cancer or other conditions.

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.
We found this trial at
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Hamilton,
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New York, New York 10003
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New York, NY
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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