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

Primary Purpose

High Risk for Breast Cancer, Risk Reduction Behavior

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Web-Based Decision Support
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional other trial for High Risk for Breast Cancer focused on measuring Web-Based Decision Support, Breast Cancer Risk

Eligibility Criteria

35 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

-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

Sites / Locations

  • National Cancer Institute (NCI), 9000 Rockville Pike

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 20, 2009
Last Updated
June 30, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00906321
Brief Title
Facilitating Web-based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk
Official Title
Facilitating Web-Based Patient Decision Support: Decision About Medication to Lower Breast Cancer Risk
Study Type
Interventional

2. Study Status

Record Verification Date
May 26, 2010
Overall Recruitment Status
Completed
Study Start Date
May 18, 2009 (undefined)
Primary Completion Date
May 26, 2010 (Actual)
Study Completion Date
May 26, 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Risk for Breast Cancer, Risk Reduction Behavior
Keywords
Web-Based Decision Support, Breast Cancer Risk

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Web-Based Decision Support
Primary Outcome Measure Information:
Title
Conduct a formative evaluation of the impact of the chemoprevention module of the Trusted Advisor for Cancer Health Decisions (TACHD) decision support intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
-INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: 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
Facility Information:
Facility Name
National Cancer Institute (NCI), 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12421895
Citation
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.
Results Reference
background
PubMed Identifier
10387940
Citation
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.
Results Reference
background
PubMed Identifier
16113531
Citation
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.
Results Reference
background

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

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