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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
McMaster University
University College, London
The New School for Social Research
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00471601
First received: May 8, 2007
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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 Intervention
Breast Cancer
Behavioral: counseling intervention
Behavioral: questionnaire administration
Behavioral: psychosocial assessment and care
Behavioral: quality-of-life assessment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Measuring Patient Expectations for Breast Reconstruction: Development and Validation of a Patient-Reported Outcomes Instrument

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Item reduction [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Psychometric evaluation [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 357
Study Start Date: March 2007
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471601

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
New School for Social Research
New York, New York, United States, 10003
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
United Kingdom
University College of London Hospitals
London, England, United Kingdom, WIT 3AA
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
McMaster University
University College, London
The New School for Social Research
Investigators
Principal Investigator: Andrea L. Pusic, MD, MHS Memorial Sloan-Kettering Cancer Center
Principal Investigator: Peter G. Cordeiro, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00471601     History of Changes
Other Study ID Numbers: 07-024, P30CA008748, MSKCC-07024
Study First Received: May 8, 2007
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 28, 2014