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Tamoxifen Citrate Decision Aids for Women at Increased Risk of Breast Cancer

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ClinicalTrials.gov Identifier: NCT00967824
Recruitment Status : Completed
First Posted : August 28, 2009
Last Update Posted : March 24, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
University of Michigan Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Other: informational intervention Other: questionnaire administration Other: survey administration Phase 1 Phase 2

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  (Clinical Trial)
Estimated Enrollment : 1683 participants
Allocation: Randomized
Official Title: Developing and Testing a Tamoxifen Prophylaxis Decision Aid
Study Start Date : October 2005
Actual Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. Development and testing of a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00967824


Sponsors and Collaborators
University of Michigan Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Angela Fagerlin, PhD University of Michigan Cancer Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter Anthony Ubel, University of Michigan Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00967824     History of Changes
Other Study ID Numbers: CDR0000649906
P50CA101451 ( U.S. NIH Grant/Contract )
P30CA046592 ( U.S. NIH Grant/Contract )
IRBMED-2004-0695 ( Other Identifier: University of Michigan Medical IRB )
First Posted: August 28, 2009    Key Record Dates
Last Update Posted: March 24, 2011
Last Verified: March 2011

Keywords provided by University of Michigan Cancer Center:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents