Tamoxifen Citrate Decision Aids for Women at Increased Risk of Breast Cancer
March 22, 2011 updated by: University of Michigan Rogel Cancer Center
Developing and Testing a Tamoxifen Prophylaxis Decision Aid
RATIONALE: Evaluating a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent breast cancer may be helpful for women at increased risk of breast cancer.
PURPOSE: This randomized phase I/II trial is studying tamoxifen citrate decision aids for women at increased risk of breast cancer.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- To develop and test a decision aid for describing the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer in women at increased risk of breast cancer.
OUTLINE:
- Phase I: Patients are randomized to view 1 of 16 decision aids that vary in terms of how the information is presented based on 5 dimensions: 1) statistical information in pictographs vs plain text, 2) risk information presented with denominators of 100 vs 1000, 3) risk information presented in terms of total vs additional risk, 4) whether the risks of tamoxifen citrate are presented before or after the benefits are presented, and 5) contextual information about other risks the patient faces (all cause mortality, colon cancer, heart attack).
Patients complete baseline and post-test questionnaires.
Phase II: Patients are randomized to 1 of 3 arms.
- Arm I (control): Patients do not view the decision aid, but complete baseline and post-test questionnaires.
- Arm II (control): Patients complete a baseline questionnaire only. They do not view the decision aid or complete the post-test questionnaire.
- Arm III (intervention): Patients view 1 of 16 decision aids that vary based on 5 factors: 1) providing (or not) comparative information about the average woman's breast cancer risk, 2) sequencing presentation of risks and benefits (risks first vs benefits first), 3) including (or not) a summary table following presentation of risks and benefits, 4) using second vs third person language ("your risk" vs "a person like you"), and 5) presenting the decision as having 2 vs 3 options (taking/not taking a breast cancer prevention drug vs taking tamoxifen citrate/raloxifene, or no drug). Patients also complete baseline and post-test questionnaires.
Patients in both phases complete an online follow-up survey at 3 months. Patients in arms I or II (of phase II) receive a decision aid after completion of the follow-up survey.
Study Type
Interventional
Enrollment (Anticipated)
1683
Phase
- Phase 2
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
DISEASE CHARACTERISTICS:
- Believed to be at increased risk of breast cancer (risk of ≥ 1.66% over 5 years) according to electronic-based medical data
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Development and testing of a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Angela Fagerlin, PhD, University of Michigan Rogel Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Korfage IJ, Fuhrel-Forbis A, Ubel PA, Zikmund-Fisher BJ, Greene SM, McClure JB, Smith DM, Alford SH, Fagerlin A. Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention. Breast Cancer Res. 2013;15(5):R74. doi: 10.1186/bcr3468.
- Banegas MP, McClure JB, Barlow WE, Ubel PA, Smith DM, Zikmund-Fisher BJ, Greene SM, Fagerlin A. Results from a randomized trial of a web-based, tailored decision aid for women at high risk for breast cancer. Patient Educ Couns. 2013 Jun;91(3):364-71. doi: 10.1016/j.pec.2012.12.014. Epub 2013 Feb 8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2005
Primary Completion (Actual)
August 1, 2008
Study Registration Dates
First Submitted
August 27, 2009
First Submitted That Met QC Criteria
August 27, 2009
First Posted (Estimate)
August 28, 2009
Study Record Updates
Last Update Posted (Estimate)
March 24, 2011
Last Update Submitted That Met QC Criteria
March 22, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000649906
- P30CA046592 (U.S. NIH Grant/Contract)
- P50CA101451 (U.S. NIH Grant/Contract)
- IRBMED-2004-0695 (Other Identifier: University of Michigan Medical IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.