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临床试验/NCT00471601
NCT00471601已完成不适用

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

Memorial Sloan Kettering Cancer Center6 个研究点 分布在 3 个国家目标入组 357 人开始时间: 2007年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
357
试验地点
6
主要终点
Item reduction

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age > or = to 18 to 75 years.
  • Patients who are presenting for consultation about breast reconstruction

排除标准

  • Inability to speak or understanding English
  • Inability to provide meaningful informed consent due to physical, cognitive, or psychiatric disability.
  • Prior breast reconstruction surgery.

结局指标

主要结局

Item reduction

时间窗: 2 years

Psychometric evaluation

时间窗: 2 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (6)

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