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


N/A
35 Years
N/A
Not Enrolling
Female
High Risk for Breast Cancer, Risk Reduction Behavior

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Trial Information

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


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.

Inclusion Criteria


-INCLUSION CRITERIA:

1. Women with no history of cancer other than cervical carcinoma in situ or non-melanoma
skin cancer

2. 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

3. Considering a decision about chemoprevention with tamoxifen or raloxifene

4. Access to an IBM-compatible or MacIntosh personal computer with broadband Internet
access

5. Access to an email account

6. Access to a telephone

7. Aged 35 or older

8. Able to communicate in English verbally and in writing

9. Women of all races and ethnic groups are eligible for this study.

EXCLUSION CRITERIA:

1. Concurrent participation in another cancer chemoprevention study

2. Prior history of cancer, other than cervical carcinoma in situ or non-melanoma skin
cancer

3. Ever taken tamoxifen or raloxifene

4. Age less than 35

5. Unable to communicate in English verbally and in writing

6. No computer with internet access

7. No email account

8. No telephone

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

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

Authority:

United States: Federal Government

Study ID:

999909150

NCT ID:

NCT00906321

Start Date:

May 2009

Completion Date:

May 2010

Related Keywords:

  • High Risk for Breast Cancer
  • Risk Reduction Behavior
  • Web-Based Decision Support
  • Breast Cancer Risk
  • Breast Neoplasms

Name

Location

National Cancer Institute (NCI), 9000 Rockville PikeBethesda, Maryland  20892