Development of a Questionnaire to Evaluate Patient Expectations for Breast Reconstruction in Women With Breast Cancer or Other Conditions - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00471601

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	Other: counseling intervention Other: questionnaire administration Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Breast Reconstruction Cancer Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Health Services Research
Official Title:	Measuring Patient Expectations for Breast Reconstruction: Development and Validation of a Patient-Reported Outcomes Instrument

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Item reduction [ Designated as safety issue: No ]
Psychometric evaluation [ Designated as safety issue: No ]

Estimated Enrollment:	480
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

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 a questionnaire (preliminary questionnaire developed after part 1) about their expectations for breast reconstructive surgery after patient education about breast reconstructive surgery.
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 Life Orientation Test-Revised (LOT-R) addressing body image, sexuality, personal well-being, and lifestyle.

PROJECTED ACCRUAL: A total of 480 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Presenting for consultation with a plastic surgeon about breast reconstruction
Hormone receptor status not specified

PATIENT CHARACTERISTICS:

Female
Menopausal status not specified
Able to speak and understand English
No physical, cognitive, or psychiatric disability that would preclude study participation

PRIOR CONCURRENT THERAPY:

No 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	Recruiting
New York, New York, United States, 10065
Contact: Andrea L. Pusic, MD, MHS 212-639-5085 pusica@mskcc.org
New School for Social Research	Recruiting
New York, New York, United States, 10003
Contact: Lisa Rubin, PhD 212-229-5700
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences	Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Anne Klassen, DPhil 905-521-2000 ext. 73464
United Kingdom, England
University College of London Hospitals	Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Stefan Cano, PhD 44-20-7636-8333

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000542896, MSKCC-07024
Study First Received:	May 8, 2007
Last Updated:	April 8, 2009
ClinicalTrials.gov Identifier:	NCT00471601 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009