Facilitating Web-based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk
Condition: High Risk for Breast Cancer; Risk Reduction Behavior
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      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
    

Detailed description: 
      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:

        -  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

      DESIGN:

        -  The project will be guided by the Cognitive-Social Health Information Processing (CSHIP)
           model overall, and incorporate the Ottawa Decision Support. Framework (ODSF) in one
           consistent decision support process.

        -  Testing of the chemoprevention decision support module will be conducted in a two-group
           pre- post-test experimental design with 64 at-risk women identified through Fox Chase
           Risk Assessment Programs and the NCI Clinical Cancer Genetics Program (CCGP) at the
           National Naval Medical Center (NNMC).

        -  A process evaluation analysis will assess participants' experiences using TACHD.
    

Intervention name(s): Web-Based Decision Support
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Web-Based Decision Support; Breast Cancer Risk