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CompletedNCT00906321Updated Jul 2, 2017

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

An interventional study of Web-Based Decision Support in High Risk for Breast Cancer and Risk Reduction Behavior, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to female participants aged 35 Years to 100 Years. Per ClinicalTrials.gov, last updated 2017-07-02.

Sponsored by National Cancer Institute (NCI) · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
35 Years to 100 Years
Sex
Female
01

Study 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
Read the 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.
02

Conditions studied

  • High Risk for Breast Cancer
  • Risk Reduction Behavior

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Keywords

  • Web-Based Decision Support
  • Breast Cancer Risk
03

In context

Breast Neoplasms

12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 64 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,505 studies on the registry; 333 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (estimated)

Interventions

  • BehavioralWeb-Based Decision Support
06

What researchers measure

Primary outcomes

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

07

Study locations

1 site
  • National Cancer Institute (NCI), 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
08

References and documents

Publications

  • Guttmacher AE, Collins FS. Genomic medicine--a primer. N Engl J Med. 2002 Nov 7;347(19):1512-20. doi: 10.1056/NEJMra012240. No abstract available. PubMed 12421895 ↗
  • Collins FS. Shattuck lecture--medical and societal consequences of the Human Genome Project. N Engl J Med. 1999 Jul 1;341(1):28-37. doi: 10.1056/NEJM199907013410106. No abstract available. PubMed 10387940 ↗
  • Rose AL, Peters N, Shea JA, Armstrong K. Attitudes and misconceptions about predictive genetic testing for cancer risk. Community Genet. 2005;8(3):145-51. doi: 10.1159/000086757. PubMed 16113531 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00906321
Lead sponsor
National Cancer Institute (NCI)
First posted
May 21, 2009
Start date
May 18, 2009
Primary completion
May 26, 2010
Completion
May 26, 2010
Last update
Jul 2, 2017
View the source record on ClinicalTrials.gov ↗

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