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

Breast Cancer Clinical Trial

Official title:

Measuring Patient Expectations for Breast Reconstruction: Development and Validation of a Patient-Reported Outcomes Instrument

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471601
• Other study ID #: 07-024
• Secondary ID: P30CA008748MSKCC
• Status: Completed
• Phase: N/A
• Start date: March 13, 2007
• Est. completion date: December 22, 2023

Study information

• Verified date: December 2023
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 357
• Est. completion date: December 22, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• counseling intervention

• questionnaire administration

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital at Hamilton Health Sciences	Hamilton	Ontario
United Kingdom	University College of London Hospitals	London	England
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New School for Social Research	New York	New York

Sponsors (5)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	McMaster University, National Cancer Institute (NCI), The New School for Social Research, University College, London

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Item reduction		2 years
Primary	Psychometric evaluation		2 years

External Links

•   Memorial Sloan Kettering Cancer Center