Development of a Questionnaire to Evaluate Patient Expectations for Breast Reconstruction in Women With Breast Cancer or Other Conditions
This study is ongoing, but not recruiting participants.
Sponsor:
Memorial Sloan-Kettering Cancer Center
Collaborators:
McMaster University
University College, London
NEW SCHOOL FOR SOCIAL RESEARCH
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00471601
First received: May 8, 2007
Last updated: March 6, 2013
Last verified: March 2013
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Purpose
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 | Intervention |
|---|---|
|
Breast Cancer |
Behavioral: counseling intervention Behavioral: questionnaire administration Behavioral: psychosocial assessment and care Behavioral: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Measuring Patient Expectations for Breast Reconstruction: Development and Validation of a Patient-Reported Outcomes Instrument |
Resource links provided by NLM:
Further study details as provided by Memorial Sloan-Kettering Cancer Center:
Primary Outcome Measures:
- Item reduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Psychometric evaluation [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 357 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Behavioral: counseling intervention Behavioral: questionnaire administration Behavioral: psychosocial assessment and care Behavioral: quality-of-life assessment |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471601
Locations
| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10065 | |
| New School for Social Research | |
| New York, New York, United States, 10003 | |
| Canada, Ontario | |
| McMaster Children's Hospital at Hamilton Health Sciences | |
| Hamilton, Ontario, Canada, L8N 3Z5 | |
| United Kingdom | |
| University College of London Hospitals | |
| London, England, United Kingdom, WIT 3AA | |
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
McMaster University
University College, London
NEW SCHOOL FOR SOCIAL RESEARCH
Investigators
| Principal Investigator: | Andrea L. Pusic, MD, MHS | Memorial Sloan-Kettering Cancer Center |
| Principal Investigator: | Peter G. Cordeiro, MD | Memorial Sloan-Kettering Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00471601 History of Changes |
| Other Study ID Numbers: | 07-024, P30CA008748, MSKCC-07024 |
| Study First Received: | May 8, 2007 |
| Last Updated: | March 6, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Memorial Sloan-Kettering Cancer Center:
|
recurrent breast cancer stage IA breast cancer stage IB breast cancer stage II breast cancer |
stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013