Development of a Questionnaire to Evaluate Patient Expectations for Breast Reconstruction in Women With Breast Cancer or Other Conditions
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

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.
    

Intervention name(s): counseling intervention; questionnaire administration; psychosocial assessment and care; quality-of-life assessment
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: 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