Development of a Questionnaire to Evaluate Patient Expectations for Breast Reconstruction in Women With Breast Cancer or Other Conditions
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|ClinicalTrials.gov Identifier: NCT00471601|
Recruitment Status : Active, not recruiting
First Posted : May 10, 2007
Last Update Posted : May 22, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Behavioral: counseling intervention Behavioral: questionnaire administration Behavioral: psychosocial assessment and care Behavioral: quality-of-life assessment||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||357 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Measuring Patient Expectations for Breast Reconstruction: Development and Validation of a Patient-Reported Outcomes Instrument|
|Study Start Date :||March 2007|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
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.
Behavioral: counseling intervention
Behavioral: questionnaire administration
Behavioral: psychosocial assessment and care
Behavioral: quality-of-life assessment
- Item reduction [ Time Frame: 2 years ]
- Psychometric evaluation [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00471601
|United States, New York|
|New School for Social Research|
|New York, New York, United States, 10003|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|McMaster Children's Hospital at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8N 3Z5|
|University College of London Hospitals|
|London, England, United Kingdom, WIT 3AA|
|Principal Investigator:||Colleen McCarthy, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Peter G. Cordeiro, MD||Memorial Sloan Kettering Cancer Center|