Facilitating Web-based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk
Information source: National Institutes of Health Clinical Center (CC)
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: High Risk for Breast Cancer; Risk Reduction Behavior
Intervention: Web-Based Decision Support (Behavioral)
Phase: N/A
Status: Recruiting
Sponsored by: National Cancer Institute (NCI) Overall contact:
Kathleen Calzone, R.N., Phone: (301) 435-0538, Email: calzonek@mail.nih.gov
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
Clinical Details
Official title: Facilitating Web-Based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk
Study design: Other, Randomized, Open Label, Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Conduct a formative evaluation of the impact of the chemoprevention module of the Trusted Advisor for Cancer Health Decisions (TACHD) decision support intervention
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.
Eligibility
Minimum age: 35 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Kathleen Calzone, R.N., Phone: (301) 435-0538, Email: calzonek@mail.nih.gov
National Cancer Institute (NCI), 9000 Rockville Pike, Bethesda, Maryland 20892, United States; Recruiting
Additional Information
Related publications: Guttmacher AE, Collins FS. Genomic medicine--a primer. N Engl J Med. 2002 Nov 7;347(19):1512-20. Review. No abstract available. Collins FS. Shattuck lecture--medical and societal consequences of the Human Genome Project. N Engl J Med. 1999 Jul 1;341(1):28-37. No abstract available. 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.
Starting date: May 2009
Ending date: June 2011
Last updated: August 27, 2009
|
