Development of a Questionnaire to Evaluate Patient Expectations for Breast Reconstruction in Women With Breast Cancer or Other Conditions
- Conditions
- Breast Cancer
- Registration Number
- NCT00471601
- Lead Sponsor
- Memorial Sloan Kettering Cancer Center
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 357
- Female.
- Age > or = to 18 to 75 years.
- Patients who are presenting for consultation about breast reconstruction
- Inability to speak or understanding English
- Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability.
- Prior breast reconstruction surgery.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Item reduction 2 years Psychometric evaluation 2 years
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
New School for Social Research
🇺🇸New York, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
McMaster Children's Hospital at Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
University College of London Hospitals
🇬🇧London, England, United Kingdom
New School for Social Research🇺🇸New York, New York, United States