Breast Cancer Clinical Trial

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

Summary

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.

View Full Description

Full Description

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.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Breast Cancer

Estimated Enrollment:

357

Study ID:

NCT00471601

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 4 Locations for this study

See Locations Near You

New School for Social Research
New York New York, 10003, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton Ontario, L8N 3, Canada
University College of London Hospitals
London England, WIT 3, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

357

Study ID:

NCT00471601

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.