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

NCT00906321 | Completed

• 2 other identifiers: 99990915009-C-N150
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

High Risk for Breast Cancer; Risk Reduction Behavior

Keywords

Web-Based Decision Support; Breast Cancer Risk

Outcome Measures

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

Interventions

Web-Based Decision Support BEHAVIORAL

Eligibility Criteria

• Age: 35 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Cancer Institute (NCI), 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 12421895 BACKGROUND

• 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.

  PMID: 10387940 BACKGROUND

• 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.

  PMID: 16113531 BACKGROUND

MeSH Terms

Conditions

Risk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 20, 2009
• First Posted: May 21, 2009
• Study Start: May 18, 2009
• Primary Completion: May 26, 2010
• Study Completion: May 26, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-05-26

Locations

US (1)