Development of a Questionnaire to Evaluate Patient Expectations for Breast Reconstruction in Women With Breast Cancer or Other Conditions
NCT ID: NCT00471601
Last Updated: 2024-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
357 participants
INTERVENTIONAL
2007-03-13
2023-12-22
Brief Summary
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PURPOSE: This clinical trial is developing a questionnaire to evaluate patient expectations for breast reconstruction in women with breast cancer or other conditions.
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Interviews/Questionnaires
The primary intervention in part 1 includes the interview for item generation with 50 women and the pilot-testing with a separate group of n = 30 women. The primary intervention in part 2 and 3 is the administration of the questionnaire. In part 3, along with the questionnaire being developed, the Body Image Scale (BIS), the Life Orientation Test-Revised (LOT-R), and the upcoming MSKCC BREAST-Q will be given to determine convergent and discriminant construct validity. No other therapeutic or diagnostic agents will be administered.
counseling intervention
questionnaire administration
psychosocial assessment and care
quality-of-life assessment
Interventions
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counseling intervention
questionnaire administration
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* Age \> or = to 18 to 75 years.
* Patients who are presenting for consultation about breast reconstruction
Exclusion Criteria
* Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability.
* Prior breast reconstruction surgery.
18 Years
75 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
McMaster University
OTHER
University College, London
OTHER
The New School for Social Research
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Colleen McCarthy, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Peter G. Cordeiro, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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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
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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MSKCC-07024
Identifier Type: -
Identifier Source: secondary_id
07-024
Identifier Type: -
Identifier Source: org_study_id
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