Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments counseling intervention, questionnaire administration, psychosocial assessment and care, quality-of-life assessment
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date March 2007
End date March 2017
Trial size 357 participants
Trial identifier NCT00471601, 07-024, MSKCC-07024, P30CA008748

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
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.
counseling intervention
questionnaire administration
psychosocial assessment and care
quality-of-life assessment

Primary Outcomes

Measure
Item reduction
time frame: 2 years
Psychometric evaluation
time frame: 2 years

Eligibility Criteria

Female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Measuring Patient Expectations for Breast Reconstruction: Development and Validation of a Patient-Reported Outcomes Instrument
Principal investigator Andrea L. Pusic, MD, MHS
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.