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临床试验/NCT01399359
NCT01399359已完成不适用

A Study to Evaluate Different Decision-Making Approaches Used by Women Known to be at Increased Risk for Breast Cancer

NSABP Foundation Inc1 个研究点 分布在 1 个国家目标入组 1,023 人开始时间: 2011年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,023
试验地点
1
主要终点
Social, environmental, and psychological influences on the decision of women at risk for breast cancer as to whether or not to take a SERM

研究概览

简要总结

RATIONALE: Learning about how patients make decisions about using chemoprevention may help doctors plan treatment in which more patients are willing to choose chemoprevention to reduce their breast cancer risk.

PURPOSE: This clinical trial studies factors influencing decision-making about the use of chemoprevention in women at increased risk for breast cancer.

详细描述

OBJECTIVES:

Primary

  • To describe the influence of social, environmental, and psychological factors (sociality of medication intake, life-events, understanding of prevention, clinical situation) on the decision of women at risk for breast cancer as to whether or not to take chemoprevention agents.

Secondary

  • To determine the implications of and influences on decision-making that a diagnosis of "being at risk for breast cancer" has for women.
  • To determine what factors hinder women from taking chemoprevention for breast cancer.
  • To field test a questionnaire that identifies the factors that influence the decision-making process of women at increased risk of breast cancer for whom chemoprevention is a medically indicated option.
  • To describe the influence of social, environmental, and psychological factors on the decision of women at risk for breast cancer as to whether or not to take chemoprevention agents by menopausal status.
  • For postmenopausal women who decide to take a selective estrogen-receptor modulator (SERM) for breast cancer prevention, to assess reasons for the choice of raloxifene versus tamoxifen.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
35 Years 至 120 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Social, environmental, and psychological influences on the decision of women at risk for breast cancer as to whether or not to take a SERM

时间窗: Measured at start of study and at 3 to 6 months

次要结局

  • The implications of and influences on decision-making that a diagnosis of "being at risk for breast cancer" has for women.(Measured at start of study and at 3 to 6 months)
  • Factors hindering women from taking chemoprevention for breast cancer(Measured at start of study and at 3 to 6 months)
  • Reasons for the choice of raloxifene vs tamoxifen among menopausal women(Measured at start of study and at 3 to 6 months)
  • To describe the influence of social, environmental, and psychological factors on the decision of women at risk for breast cancer as to whether or not to take chemoprevention agents by menopausal status.(Measured at start of study and at 3 to 6 months)
  • To test a questionnaire that identifies the factors that influence the decision-making process of women at increased risk of breast cancer for whom chemoprevention is a medically-indicated option.(Measured at start of study and at 3 to 6 months)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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