Development of a Questionnaire to Evaluate Patient Expectations for Breast Reconstruction in Women With Breast Cancer or Other Conditions
This trial is active, not recruiting.
|Treatments||counseling intervention, questionnaire administration, psychosocial assessment and care, quality-of-life assessment|
|Sponsor||Memorial Sloan Kettering Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||March 2007|
|End date||March 2017|
|Trial size||357 participants|
|Trial identifier||NCT00471601, 07-024, MSKCC-07024, P30CA008748|
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.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|New York, NY||New School for Social Research||no longer recruiting|
|New York, NY||Memorial Sloan Kettering Cancer Center||no longer recruiting|
|Hamilton, Canada||McMaster Children's Hospital at Hamilton Health Sciences||no longer recruiting|
|London, United Kingdom||University College of London Hospitals||no longer recruiting|
|Intervention model||single group assignment|
|Primary purpose||health services research|
time frame: 2 years
time frame: 2 years
Female participants from 18 years up to 75 years old.
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.
|Official title||Measuring Patient Expectations for Breast Reconstruction: Development and Validation of a Patient-Reported Outcomes Instrument|
|Principal investigator||Andrea L. Pusic, MD, MHS|
|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.|
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