Clinical trial NCT00471601: Development of a Questionnaire to Evaluate Patient Expectations for Breast Reconstruction in Women With Breast Cancer or Other Conditions
Official title: Measuring Patient Expectations for Breast Reconstruction: Development and Validation of a Patient-Reported Outcomes Instrument
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: McMaster University
name: University College, London
name: The New School for Social Research
First posted: 2007-05-10
Enrollment: 357
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

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 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.

Primary outcomes:
measure: Item reduction
timeFrame: 2 years
measure: Psychometric evaluation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New School for Social Research
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Hamilton
country: Canada
facility: McMaster Children's Hospital at Hamilton Health Sciences
state: Ontario
city: London
country: United Kingdom
facility: University College of London Hospitals
state: England
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Colleen McCarthy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Memorial Sloan Kettering Cancer Center
name: Peter G. Cordeiro, MD
role: PRINCIPAL_INVESTIGATOR
References: