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临床试验/NCT00906321
NCT00906321已完成不适用

Facilitating Web-Based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk

National Cancer Institute (NCI)1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2009年5月18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
64
试验地点
1
主要终点
Conduct a formative evaluation of the impact of the chemoprevention module of the Trusted Advisor for Cancer Health Decisions (TACHD) decision support intervention

研究概览

简要总结

Background:

  • Chemoprevention is the use of preventive medications to reduce the risk of breast cancer for women who are at a high risk of developing the disease. Although the treatment has shown effectiveness in preventing cancer development, chemoprevention is notably underutilized even by women who are at a high risk of developing breast cancer.
  • Researchers are interested in determining if better decision support mechanisms, such as interactive Web sites, can help to overcome some of the barriers to chemoprevention.

Objectives:

- To develop and test a prototype Web-based module that will provide decision support to women who are considering chemoprevention for breast cancer.

Eligibility:

  • Women 35 years of age and older who are at high risk for breast cancer and whose doctor has recommended chemoprevention (either Tamoxifen or Raloxifene), and who have no other history of cancer (apart from non-melanoma skin cancer or precancerous cervical lesions).
  • Participants must have a working e-mail address and access to a computer with internet access and a telephone.

Design:

  • Participants who are considering chemoprevention will be randomized to a Web-based decision support module or standard care online information resources.
  • Participation lasts two months and involves using the online resources provided and filling out questionnaires two times during the study (at the beginning and the end).

The first time will be at the begin of the study.

  • No medical treatments are offered as a part of this study

详细描述

BACKGROUND:

  • Breast cancer chemoprevention has been notably underutilized.
  • Barriers to integrating breast cancer risk reducing measures include: lack of time, low priority of risk reduction in comparison to treatment, the need to personalize risks and benefits of chemoprevention, and the need for resources/information necessary for women to make informed decisions.
  • Access to quality decision support resources to facilitate making informed, preference-sensitive decisions about chemoprevention may provide a mechanism to overcome some of the current barriers to chemoprevention utilization.

OBJECTIVES:

  • Develop and refine a web-based patient decision support module for high-risk women making a decision about breast cancer chemoprevention.
  • Conduct a randomized study of TACHD decision support versus standard care online information support to evaluate the impact of the chemoprevention module of the TACHD decision support intervention.

ELIGIBILITY:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
35 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •INCLUSION CRITERIA:
  • •Women with no history of cancer other than cervical carcinoma in situ or non-melanoma skin cancer
  • •High risk for breast cancer based on at least one of the following:
  • •Gail score > 1.67
  • •History of atypical hyperplasia (either ductal or lobular)
  • •History of lobular carcinoma in situ
  • •Documentation of a deleterious BRCA1 or BRCA2 mutation
  • •Considering a decision about chemoprevention with tamoxifen or raloxifene
  • •Access to an IBM-compatible or MacIntosh personal computer with broadband Internet access
  • •Access to an email account
  • •Access to a telephone
  • •Aged 35 or older
  • •Able to communicate in English verbally and in writing
  • •Women of all races and ethnic groups are eligible for this study.

排除标准

  • •Concurrent participation in another cancer chemoprevention study
  • •Prior history of cancer, other than cervical carcinoma in situ or non-melanoma skin cancer
  • •Ever taken tamoxifen or raloxifene
  • •Age less than 35
  • •Unable to communicate in English verbally and in writing
  • •No computer with internet access
  • •No email account
  • •No telephone

结局指标

主要结局

Conduct a formative evaluation of the impact of the chemoprevention module of the Trusted Advisor for Cancer Health Decisions (TACHD) decision support intervention

次要结局

未报告次要终点

研究者

申办方类型
Nih

研究点 (1)

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