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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00471601

Collaborator

National Cancer Institute (NCI) (NIH), McMaster University (Other), University College, London (Other), The New School for Social Research (Other)

357

Enrollment

Locations

Arm

186.1

Duration (Months)

89.3

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Behavioral: counseling intervention Behavioral: questionnaire administration Behavioral: psychosocial assessment and care Behavioral: quality-of-life assessment	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

357 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Study Start Date :

Mar 1, 2007

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Item reduction [2 years]
Psychometric evaluation [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	New School for Social Research	New York	New York	United States	10003
2	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
3	McMaster Children's Hospital at Hamilton Health Sciences	Hamilton	Ontario	Canada	L8N 3Z5
4	University College of London Hospitals	London	England	United Kingdom	WIT 3AA

Sponsors and Collaborators

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

Investigators

Principal Investigator: Colleen McCarthy, MD, Memorial Sloan Kettering Cancer Center
Principal Investigator: Peter G. Cordeiro, MD, Memorial Sloan Kettering Cancer Center