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

December 28, 2023 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

357

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
  • United Kingdom
    • England
      • London, England, United Kingdom, WIT 3AA
        • University College of London Hospitals
  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10003
        • New School for Social Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Item reduction
Time Frame: 2 years
2 years
Psychometric evaluation
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2007

Primary Completion (Actual)

December 22, 2023

Study Completion (Actual)

December 22, 2023

Study Registration Dates

First Submitted

May 8, 2007

First Submitted That Met QC Criteria

May 8, 2007

First Posted (Estimated)

May 10, 2007

Study Record Updates

Last Update Posted (Estimated)

January 1, 2024

Last Update Submitted That Met QC Criteria

December 28, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-024
  • P30CA008748 (U.S. NIH Grant/Contract)
  • MSKCC-07024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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